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Risk of adverse birth outcomes for singleton infants born to ART-treated or subfertile women

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Fri, 01/18/2019 - 17:46

 

Singleton infants born to mothers who are subfertile or treated with assisted reproductive technology (ART) are at higher risk for multiple adverse health outcomes beyond prematurity, a recent retrospective study shows.

Risks of chromosomal abnormalities, infectious diseases, and cardiovascular and respiratory conditions were all increased, compared with infants born to fertile mothers, in analyses of neonatal outcomes stratified by gestational age.

This population-based study is among the first to show differences in adverse birth outcomes beyond preterm birth and, more specifically, by organ system conditions across gestational age categories, according to Sunah S. Hwang, MD, MPH, of the University of Colorado at Denver, Aurora, and her coinvestigators.

“With this approach, we offer more detailed associations between maternal fertility and the receipt of treatment along the continuum of fetal organ development and subsequent infant health conditions,” Dr. Hwang and her coauthors wrote in Pediatrics.

The study, which included singleton infants of at least 23 weeks’ gestational age born during 2004-2010, was based on data from a Massachusetts clinical ART database (MOSART) that was linked with state vital records.

Out of 350,123 infants with birth hospitalization records in the study cohort, 336,705 were born to fertile women, while 8,375 were born to women treated with ART, and 5,403 were born to subfertile women.

After adjustment for key maternal and infant characteristics, infants born to subfertile or ART-treated women were more often preterm as compared with infants to fertile mothers. Adjusted odds ratios were 1.39 (95% confidence interval, 1.26-1.54) and 1.72 (95% CI, 1.60-1.85) for infants of subfertile and ART-treated women, respectively, Dr. Hwang and her coinvestigators reported.

Infants born to subfertile or ART-treated women were also more likely to have adverse respiratory, gastrointestinal, or nutritional outcomes, with adjusted ORs ranging from 1.12 to 1.18, they added in the report.

Looking specifically at outcomes stratified by gestational age, they found an increased risk of congenital malformations, infectious diseases, and cardiovascular or respiratory outcomes, with adjusted ORs from 1.30 to 2.61, in the data published in the journal.

By contrast, there were no differences in risks of neonatal mortality, length of hospitalization, low birth weight, or neurologic and hematologic abnormalities for infants of subfertile and ART-treated women, compared with fertile women, according to Dr. Hwang and her coauthors.

These results confirm results of some previous studies that suggested a higher risk of adverse birth outcomes among infants born as singletons, according to the study authors.

“Although it is clearly accepted that multiple gestation is a significant predictor of preterm birth and low birth weight, recent studies have also revealed that, even among singleton births, mothers with infertility without ART treatment along with those who do undergo ART treatment are at higher risk for preterm delivery,” they wrote.

The study was funded by a grant from the National Institutes of Health. Authors said they had no financial relationships relevant to the study.

SOURCE: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.

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Singleton infants born to mothers who are subfertile or treated with assisted reproductive technology (ART) are at higher risk for multiple adverse health outcomes beyond prematurity, a recent retrospective study shows.

Risks of chromosomal abnormalities, infectious diseases, and cardiovascular and respiratory conditions were all increased, compared with infants born to fertile mothers, in analyses of neonatal outcomes stratified by gestational age.

This population-based study is among the first to show differences in adverse birth outcomes beyond preterm birth and, more specifically, by organ system conditions across gestational age categories, according to Sunah S. Hwang, MD, MPH, of the University of Colorado at Denver, Aurora, and her coinvestigators.

“With this approach, we offer more detailed associations between maternal fertility and the receipt of treatment along the continuum of fetal organ development and subsequent infant health conditions,” Dr. Hwang and her coauthors wrote in Pediatrics.

The study, which included singleton infants of at least 23 weeks’ gestational age born during 2004-2010, was based on data from a Massachusetts clinical ART database (MOSART) that was linked with state vital records.

Out of 350,123 infants with birth hospitalization records in the study cohort, 336,705 were born to fertile women, while 8,375 were born to women treated with ART, and 5,403 were born to subfertile women.

After adjustment for key maternal and infant characteristics, infants born to subfertile or ART-treated women were more often preterm as compared with infants to fertile mothers. Adjusted odds ratios were 1.39 (95% confidence interval, 1.26-1.54) and 1.72 (95% CI, 1.60-1.85) for infants of subfertile and ART-treated women, respectively, Dr. Hwang and her coinvestigators reported.

Infants born to subfertile or ART-treated women were also more likely to have adverse respiratory, gastrointestinal, or nutritional outcomes, with adjusted ORs ranging from 1.12 to 1.18, they added in the report.

Looking specifically at outcomes stratified by gestational age, they found an increased risk of congenital malformations, infectious diseases, and cardiovascular or respiratory outcomes, with adjusted ORs from 1.30 to 2.61, in the data published in the journal.

By contrast, there were no differences in risks of neonatal mortality, length of hospitalization, low birth weight, or neurologic and hematologic abnormalities for infants of subfertile and ART-treated women, compared with fertile women, according to Dr. Hwang and her coauthors.

These results confirm results of some previous studies that suggested a higher risk of adverse birth outcomes among infants born as singletons, according to the study authors.

“Although it is clearly accepted that multiple gestation is a significant predictor of preterm birth and low birth weight, recent studies have also revealed that, even among singleton births, mothers with infertility without ART treatment along with those who do undergo ART treatment are at higher risk for preterm delivery,” they wrote.

The study was funded by a grant from the National Institutes of Health. Authors said they had no financial relationships relevant to the study.

SOURCE: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.

 

Singleton infants born to mothers who are subfertile or treated with assisted reproductive technology (ART) are at higher risk for multiple adverse health outcomes beyond prematurity, a recent retrospective study shows.

Risks of chromosomal abnormalities, infectious diseases, and cardiovascular and respiratory conditions were all increased, compared with infants born to fertile mothers, in analyses of neonatal outcomes stratified by gestational age.

This population-based study is among the first to show differences in adverse birth outcomes beyond preterm birth and, more specifically, by organ system conditions across gestational age categories, according to Sunah S. Hwang, MD, MPH, of the University of Colorado at Denver, Aurora, and her coinvestigators.

“With this approach, we offer more detailed associations between maternal fertility and the receipt of treatment along the continuum of fetal organ development and subsequent infant health conditions,” Dr. Hwang and her coauthors wrote in Pediatrics.

The study, which included singleton infants of at least 23 weeks’ gestational age born during 2004-2010, was based on data from a Massachusetts clinical ART database (MOSART) that was linked with state vital records.

Out of 350,123 infants with birth hospitalization records in the study cohort, 336,705 were born to fertile women, while 8,375 were born to women treated with ART, and 5,403 were born to subfertile women.

After adjustment for key maternal and infant characteristics, infants born to subfertile or ART-treated women were more often preterm as compared with infants to fertile mothers. Adjusted odds ratios were 1.39 (95% confidence interval, 1.26-1.54) and 1.72 (95% CI, 1.60-1.85) for infants of subfertile and ART-treated women, respectively, Dr. Hwang and her coinvestigators reported.

Infants born to subfertile or ART-treated women were also more likely to have adverse respiratory, gastrointestinal, or nutritional outcomes, with adjusted ORs ranging from 1.12 to 1.18, they added in the report.

Looking specifically at outcomes stratified by gestational age, they found an increased risk of congenital malformations, infectious diseases, and cardiovascular or respiratory outcomes, with adjusted ORs from 1.30 to 2.61, in the data published in the journal.

By contrast, there were no differences in risks of neonatal mortality, length of hospitalization, low birth weight, or neurologic and hematologic abnormalities for infants of subfertile and ART-treated women, compared with fertile women, according to Dr. Hwang and her coauthors.

These results confirm results of some previous studies that suggested a higher risk of adverse birth outcomes among infants born as singletons, according to the study authors.

“Although it is clearly accepted that multiple gestation is a significant predictor of preterm birth and low birth weight, recent studies have also revealed that, even among singleton births, mothers with infertility without ART treatment along with those who do undergo ART treatment are at higher risk for preterm delivery,” they wrote.

The study was funded by a grant from the National Institutes of Health. Authors said they had no financial relationships relevant to the study.

SOURCE: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.

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Key clinical point: Subfertility, whether treated by ART or not, is associated with adverse health outcomes for infants.

Major finding: Infants of subfertile and ART-treated women were more likely to be born preterm (odds ratios, 1.39 and 1.72, respectively) than were the infants of fertile women.

Study details: Population-based study of 350,123 infants from a Massachusetts clinical database.

Disclosures: The study was funded by a grant from the National Institutes of Health. The authors said they had no financial relationships relevant to the study.

Source: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.

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Urge expectant parents to have prenatal pediatrician visit

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Fri, 01/18/2019 - 17:45

 

All parents-to-be, especially first-time parents, should visit a pediatrician during the third trimester of pregnancy to establish a relationship, according to an updated clinical report on the prenatal visit issued by the American Academy of Pediatrics. The report was published online June 25 and in the July issue of Pediatrics.

“It’s a chance to talk about how to keep a baby safe and thriving physically, but also ways to build strong parent-child bonds that promote resilience and help a child stay emotionally healthy,” Michael Yogman, MD, of Harvard Medical School, Boston, said in a statement. Dr. Yogman was the lead author of the report and chair of the AAP Committee on Psychosocial Aspects of Child and Family Health.

Doctor talking to pregnant patient.
Vesnaandjic/E+/Getty Images

A comprehensive prenatal visit gives pediatricians the opportunity to meet four objectives: build a trusting relationship with parents, gather information about family history, provide advice and guidance on infant care and safety, and identify risk factors for psychosocial issues such as perinatal depression, according to the report in Pediatrics.

The prenatal visit allows families and clinicians to learn whether their philosophies align to start a relationship that may last for many years and this visit can include extended family members such as grandparents. In addition, pediatricians can use the prenatal visit as an opportunity to learn more about family history including past pregnancies, failed and successful, as well as pregnancy complications, chronic medical conditions in family members that may affect the home environment, and plans for child care if parents will be working outside the home.

The report also emphasizes “positive parenting” and the role of pediatricians at a prenatal visit in offering support and guidance to help prepare parents for infant care. This guidance may include advice on feeding, sleeping, diapering, and bathing, as well as acknowledging cultural practices.

The authors noted that a prime opporunity to schedule the prenatal visit is when an expectant parent seeking information about insurance, practice hours, and whether the practice is taking new patients.

The AAP advises clinicians to encourage same sex parents, parents expecting via surrogate, and parents who are adopting to schedule a prenatal visit to identify particular concerns they may have.

“This is the only routine child wellness visit recommended by the American Academy of Pediatrics that doesn’t actually require a child in the room,” coauthor Arthur Lavin, MD, also of Harvard Medical School, said in a statement.

The prenatal visit “gives parents an opportunity to really focus on any questions and concerns they may have. They can talk with a pediatrician before the fatigue of new parenthood sets in and there’s an adorably distracting little human in their arms who may be crying, spitting up, or in immediate need of feeding or a diaper change,” Dr. Lavin said.

“At its heart and soul,” Dr. Lavin noted, “this visit is about laying a foundation for a trusting, supportive relationship between the family and their pediatrician, who will work together to keep the child healthy for the next 18 or 20 years.”

The report recommends the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Fourth Edition, as a resource for clinicians. The researchers had no financial conflicts to disclose.

SOURCE: Yogman M et al. Pediatrics. 2018; doi: 10.1542/peds. 2018-1218

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All parents-to-be, especially first-time parents, should visit a pediatrician during the third trimester of pregnancy to establish a relationship, according to an updated clinical report on the prenatal visit issued by the American Academy of Pediatrics. The report was published online June 25 and in the July issue of Pediatrics.

“It’s a chance to talk about how to keep a baby safe and thriving physically, but also ways to build strong parent-child bonds that promote resilience and help a child stay emotionally healthy,” Michael Yogman, MD, of Harvard Medical School, Boston, said in a statement. Dr. Yogman was the lead author of the report and chair of the AAP Committee on Psychosocial Aspects of Child and Family Health.

Doctor talking to pregnant patient.
Vesnaandjic/E+/Getty Images

A comprehensive prenatal visit gives pediatricians the opportunity to meet four objectives: build a trusting relationship with parents, gather information about family history, provide advice and guidance on infant care and safety, and identify risk factors for psychosocial issues such as perinatal depression, according to the report in Pediatrics.

The prenatal visit allows families and clinicians to learn whether their philosophies align to start a relationship that may last for many years and this visit can include extended family members such as grandparents. In addition, pediatricians can use the prenatal visit as an opportunity to learn more about family history including past pregnancies, failed and successful, as well as pregnancy complications, chronic medical conditions in family members that may affect the home environment, and plans for child care if parents will be working outside the home.

The report also emphasizes “positive parenting” and the role of pediatricians at a prenatal visit in offering support and guidance to help prepare parents for infant care. This guidance may include advice on feeding, sleeping, diapering, and bathing, as well as acknowledging cultural practices.

The authors noted that a prime opporunity to schedule the prenatal visit is when an expectant parent seeking information about insurance, practice hours, and whether the practice is taking new patients.

The AAP advises clinicians to encourage same sex parents, parents expecting via surrogate, and parents who are adopting to schedule a prenatal visit to identify particular concerns they may have.

“This is the only routine child wellness visit recommended by the American Academy of Pediatrics that doesn’t actually require a child in the room,” coauthor Arthur Lavin, MD, also of Harvard Medical School, said in a statement.

The prenatal visit “gives parents an opportunity to really focus on any questions and concerns they may have. They can talk with a pediatrician before the fatigue of new parenthood sets in and there’s an adorably distracting little human in their arms who may be crying, spitting up, or in immediate need of feeding or a diaper change,” Dr. Lavin said.

“At its heart and soul,” Dr. Lavin noted, “this visit is about laying a foundation for a trusting, supportive relationship between the family and their pediatrician, who will work together to keep the child healthy for the next 18 or 20 years.”

The report recommends the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Fourth Edition, as a resource for clinicians. The researchers had no financial conflicts to disclose.

SOURCE: Yogman M et al. Pediatrics. 2018; doi: 10.1542/peds. 2018-1218

 

All parents-to-be, especially first-time parents, should visit a pediatrician during the third trimester of pregnancy to establish a relationship, according to an updated clinical report on the prenatal visit issued by the American Academy of Pediatrics. The report was published online June 25 and in the July issue of Pediatrics.

“It’s a chance to talk about how to keep a baby safe and thriving physically, but also ways to build strong parent-child bonds that promote resilience and help a child stay emotionally healthy,” Michael Yogman, MD, of Harvard Medical School, Boston, said in a statement. Dr. Yogman was the lead author of the report and chair of the AAP Committee on Psychosocial Aspects of Child and Family Health.

Doctor talking to pregnant patient.
Vesnaandjic/E+/Getty Images

A comprehensive prenatal visit gives pediatricians the opportunity to meet four objectives: build a trusting relationship with parents, gather information about family history, provide advice and guidance on infant care and safety, and identify risk factors for psychosocial issues such as perinatal depression, according to the report in Pediatrics.

The prenatal visit allows families and clinicians to learn whether their philosophies align to start a relationship that may last for many years and this visit can include extended family members such as grandparents. In addition, pediatricians can use the prenatal visit as an opportunity to learn more about family history including past pregnancies, failed and successful, as well as pregnancy complications, chronic medical conditions in family members that may affect the home environment, and plans for child care if parents will be working outside the home.

The report also emphasizes “positive parenting” and the role of pediatricians at a prenatal visit in offering support and guidance to help prepare parents for infant care. This guidance may include advice on feeding, sleeping, diapering, and bathing, as well as acknowledging cultural practices.

The authors noted that a prime opporunity to schedule the prenatal visit is when an expectant parent seeking information about insurance, practice hours, and whether the practice is taking new patients.

The AAP advises clinicians to encourage same sex parents, parents expecting via surrogate, and parents who are adopting to schedule a prenatal visit to identify particular concerns they may have.

“This is the only routine child wellness visit recommended by the American Academy of Pediatrics that doesn’t actually require a child in the room,” coauthor Arthur Lavin, MD, also of Harvard Medical School, said in a statement.

The prenatal visit “gives parents an opportunity to really focus on any questions and concerns they may have. They can talk with a pediatrician before the fatigue of new parenthood sets in and there’s an adorably distracting little human in their arms who may be crying, spitting up, or in immediate need of feeding or a diaper change,” Dr. Lavin said.

“At its heart and soul,” Dr. Lavin noted, “this visit is about laying a foundation for a trusting, supportive relationship between the family and their pediatrician, who will work together to keep the child healthy for the next 18 or 20 years.”

The report recommends the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Fourth Edition, as a resource for clinicians. The researchers had no financial conflicts to disclose.

SOURCE: Yogman M et al. Pediatrics. 2018; doi: 10.1542/peds. 2018-1218

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Research provides more evidence of a maternal diabetes/autism link

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– Longer-term data are providing more evidence of a possible link between maternal diabetes and autism spectrum disorder in their children.

Anny Xiang, PhD, and coathors with Kaiser Permanente of Southern California sought to further understand the possible effect of maternal T1D on offspring’s development of autism spectrum disorder (ASD) by expanding the cohort and timeline of their earlier work (JAMA. 2015;313(14):1425-1434).

The current study includes data on to 419,425 children (51% boys) born at Kaiser Permanente Southern California hospitals from 1995-2012. The children were followed for a median of 6.9 years, through 2017.

A total of 621 children were exposed in utero to T1D , 9,453 to T2D, 11,922 to gestational diabetes diagnosed by 26 weeks, and 24,505 to gestational diabetes diagnosed after 26 weeks.


Across the cohort, 1.3% of children were diagnosed with autism spectrum disorder (ASD). The rate was barely different, at 1.5%, for those whose mothers developed gestational diabetes after 26 weeks. But rates of ASD were higher – 3.1%, 2.5%, 2.1% – among those whose mothers had T1D, T2D, and gestational diabetes that developed at 26 weeks or earlier, respectively. The findings were adjusted for co-founders such as birth year, age at delivery, eduction level and income, Dr. Xiang said at the annual scientific sessions of the American Diabetes Association.

Compared to offspring of mothers without diabetes, ASD was more common in the children of mothers with T1D (adjusted HR=2.36, 95% CI, 1.36-4.12) mothers with type 2 diabetes (AHR= 1.45, 95% CI, 1.24-1.70) and gestational diabetes mellitus that developed by 26 weeks gestation (1.30, 95% CI, 1.12-1.51).

The numbers remained similar after they were adjusted for smoking during pregnancy and prepregnancy BMI, statistics which were available for about 36% of the subjects, according to the findings which were published simultaneously in JAMA (June 23, 2018. doi:10.1001/jama.2018.7614).

Possible explanations for the link between ASD and maternal diabetes include maternal glycemic control, prematurity, and levels of neonatal hypoglycemia, Dr. Xiang said.

The results do not take into account any paternal risks for offspring developing ASD, which also includes diabetes, Dr. Xiang said, noting that two previous studies linked diabetes in fathers to ASD, although to a lesser extent than diabetes in mothers. (Epidemiology. 2010 Nov;21(6):805-8; Pediatrics. 2009 Aug;124(2):687-94)

The study also doesn’t take breastfeeding into account, Dr. Xiang noted. A 2016 study found that women with T2D were less likely to breastfeed (J Matern Fetal Neonatal Med. 2016;29(15):2513-8), and some research has suggested that breastfeeding may be protective against the development of ASD in children (Nutrition 2012;28(7-8):e27-32).

In addition, the study doesn’t track maternal glucose levels over time.

Session co-chair Peter Damm, MD, professor of obstetrics at the University of Copenhagen, said in an interview that he is impressed by the study. He cautioned, however, that it does not prove a connection.“This not a proof, but it seems likely, or like a possibility,” he said.

One possible explanation for a diabetes/ASD connection is the fact that the fetal brain is evolving throughout pregnancy unlike other body organs, which simply grow after developing in the first trimester, he said. As a result, glucose levels may affect the brain’s development in a unique way compared to other organs.

 

 

He also noted that the impact may be reduced when pregnancy is further along, potentially explaining why researchers didn’t connect late-developing gestational diabetes to ASD.

There’s still a “low risk” of ASD even in children born to mothers with diabetes, he said. “You shouldn’t scare anyone with this.”

The study was funded in part by Kaiser Permanente Southern California Direct Community Benefit funds. The study authors and Dr. Damm report no relevant disclosures.

SOURCE: Xiang A, et al. ADA 2018 Abstract OR-117.

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– Longer-term data are providing more evidence of a possible link between maternal diabetes and autism spectrum disorder in their children.

Anny Xiang, PhD, and coathors with Kaiser Permanente of Southern California sought to further understand the possible effect of maternal T1D on offspring’s development of autism spectrum disorder (ASD) by expanding the cohort and timeline of their earlier work (JAMA. 2015;313(14):1425-1434).

The current study includes data on to 419,425 children (51% boys) born at Kaiser Permanente Southern California hospitals from 1995-2012. The children were followed for a median of 6.9 years, through 2017.

A total of 621 children were exposed in utero to T1D , 9,453 to T2D, 11,922 to gestational diabetes diagnosed by 26 weeks, and 24,505 to gestational diabetes diagnosed after 26 weeks.


Across the cohort, 1.3% of children were diagnosed with autism spectrum disorder (ASD). The rate was barely different, at 1.5%, for those whose mothers developed gestational diabetes after 26 weeks. But rates of ASD were higher – 3.1%, 2.5%, 2.1% – among those whose mothers had T1D, T2D, and gestational diabetes that developed at 26 weeks or earlier, respectively. The findings were adjusted for co-founders such as birth year, age at delivery, eduction level and income, Dr. Xiang said at the annual scientific sessions of the American Diabetes Association.

Compared to offspring of mothers without diabetes, ASD was more common in the children of mothers with T1D (adjusted HR=2.36, 95% CI, 1.36-4.12) mothers with type 2 diabetes (AHR= 1.45, 95% CI, 1.24-1.70) and gestational diabetes mellitus that developed by 26 weeks gestation (1.30, 95% CI, 1.12-1.51).

The numbers remained similar after they were adjusted for smoking during pregnancy and prepregnancy BMI, statistics which were available for about 36% of the subjects, according to the findings which were published simultaneously in JAMA (June 23, 2018. doi:10.1001/jama.2018.7614).

Possible explanations for the link between ASD and maternal diabetes include maternal glycemic control, prematurity, and levels of neonatal hypoglycemia, Dr. Xiang said.

The results do not take into account any paternal risks for offspring developing ASD, which also includes diabetes, Dr. Xiang said, noting that two previous studies linked diabetes in fathers to ASD, although to a lesser extent than diabetes in mothers. (Epidemiology. 2010 Nov;21(6):805-8; Pediatrics. 2009 Aug;124(2):687-94)

The study also doesn’t take breastfeeding into account, Dr. Xiang noted. A 2016 study found that women with T2D were less likely to breastfeed (J Matern Fetal Neonatal Med. 2016;29(15):2513-8), and some research has suggested that breastfeeding may be protective against the development of ASD in children (Nutrition 2012;28(7-8):e27-32).

In addition, the study doesn’t track maternal glucose levels over time.

Session co-chair Peter Damm, MD, professor of obstetrics at the University of Copenhagen, said in an interview that he is impressed by the study. He cautioned, however, that it does not prove a connection.“This not a proof, but it seems likely, or like a possibility,” he said.

One possible explanation for a diabetes/ASD connection is the fact that the fetal brain is evolving throughout pregnancy unlike other body organs, which simply grow after developing in the first trimester, he said. As a result, glucose levels may affect the brain’s development in a unique way compared to other organs.

 

 

He also noted that the impact may be reduced when pregnancy is further along, potentially explaining why researchers didn’t connect late-developing gestational diabetes to ASD.

There’s still a “low risk” of ASD even in children born to mothers with diabetes, he said. “You shouldn’t scare anyone with this.”

The study was funded in part by Kaiser Permanente Southern California Direct Community Benefit funds. The study authors and Dr. Damm report no relevant disclosures.

SOURCE: Xiang A, et al. ADA 2018 Abstract OR-117.

 

– Longer-term data are providing more evidence of a possible link between maternal diabetes and autism spectrum disorder in their children.

Anny Xiang, PhD, and coathors with Kaiser Permanente of Southern California sought to further understand the possible effect of maternal T1D on offspring’s development of autism spectrum disorder (ASD) by expanding the cohort and timeline of their earlier work (JAMA. 2015;313(14):1425-1434).

The current study includes data on to 419,425 children (51% boys) born at Kaiser Permanente Southern California hospitals from 1995-2012. The children were followed for a median of 6.9 years, through 2017.

A total of 621 children were exposed in utero to T1D , 9,453 to T2D, 11,922 to gestational diabetes diagnosed by 26 weeks, and 24,505 to gestational diabetes diagnosed after 26 weeks.


Across the cohort, 1.3% of children were diagnosed with autism spectrum disorder (ASD). The rate was barely different, at 1.5%, for those whose mothers developed gestational diabetes after 26 weeks. But rates of ASD were higher – 3.1%, 2.5%, 2.1% – among those whose mothers had T1D, T2D, and gestational diabetes that developed at 26 weeks or earlier, respectively. The findings were adjusted for co-founders such as birth year, age at delivery, eduction level and income, Dr. Xiang said at the annual scientific sessions of the American Diabetes Association.

Compared to offspring of mothers without diabetes, ASD was more common in the children of mothers with T1D (adjusted HR=2.36, 95% CI, 1.36-4.12) mothers with type 2 diabetes (AHR= 1.45, 95% CI, 1.24-1.70) and gestational diabetes mellitus that developed by 26 weeks gestation (1.30, 95% CI, 1.12-1.51).

The numbers remained similar after they were adjusted for smoking during pregnancy and prepregnancy BMI, statistics which were available for about 36% of the subjects, according to the findings which were published simultaneously in JAMA (June 23, 2018. doi:10.1001/jama.2018.7614).

Possible explanations for the link between ASD and maternal diabetes include maternal glycemic control, prematurity, and levels of neonatal hypoglycemia, Dr. Xiang said.

The results do not take into account any paternal risks for offspring developing ASD, which also includes diabetes, Dr. Xiang said, noting that two previous studies linked diabetes in fathers to ASD, although to a lesser extent than diabetes in mothers. (Epidemiology. 2010 Nov;21(6):805-8; Pediatrics. 2009 Aug;124(2):687-94)

The study also doesn’t take breastfeeding into account, Dr. Xiang noted. A 2016 study found that women with T2D were less likely to breastfeed (J Matern Fetal Neonatal Med. 2016;29(15):2513-8), and some research has suggested that breastfeeding may be protective against the development of ASD in children (Nutrition 2012;28(7-8):e27-32).

In addition, the study doesn’t track maternal glucose levels over time.

Session co-chair Peter Damm, MD, professor of obstetrics at the University of Copenhagen, said in an interview that he is impressed by the study. He cautioned, however, that it does not prove a connection.“This not a proof, but it seems likely, or like a possibility,” he said.

One possible explanation for a diabetes/ASD connection is the fact that the fetal brain is evolving throughout pregnancy unlike other body organs, which simply grow after developing in the first trimester, he said. As a result, glucose levels may affect the brain’s development in a unique way compared to other organs.

 

 

He also noted that the impact may be reduced when pregnancy is further along, potentially explaining why researchers didn’t connect late-developing gestational diabetes to ASD.

There’s still a “low risk” of ASD even in children born to mothers with diabetes, he said. “You shouldn’t scare anyone with this.”

The study was funded in part by Kaiser Permanente Southern California Direct Community Benefit funds. The study authors and Dr. Damm report no relevant disclosures.

SOURCE: Xiang A, et al. ADA 2018 Abstract OR-117.

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Key clinical point: Children of mothers with various forms of diabetes – including type 1 diabetes (T1D) – could be at higher risk of autism.

Major finding: Autism spectrum disorder (ASD) was more common in the children of mothers with T1D (adjusted HR=2.36, 95% CI, 1.36-4.12) type 2 diabetes (AHR= 1.45, 95% CI, 1.24-1.70) and gestational diabetes that developed by 26 weeks gestation (1.30, 95% CI, 1.12-1.51).

Study details: Retrospective analysis of 419,425 children born at Kaiser Permanente Southern California hospitals from 1995-2012 (51% boys).

Disclosures: The study was funded in part by Kaiser Permanente Southern California Direct Community Benefit funds. The study authors report no relevant disclosures.

Source: Xiang A, et al. ADA 2018 Abstract OR-117.

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Could tackling maternal obesity prevent later CVD in offspring?

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Fri, 01/18/2019 - 17:45

 

Offspring of obese mothers should be regarded as a high-risk population for endothelial cell dysfunction and, therefore, for cardiovascular events later in life, authors of a thematic literature review concluded.

Maternal obesity has been tied to the development of cardiovascular disease (CVD) and premature death in epidemiologic studies, the authors noted in the review.

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One hypothesis, referred to as fetal programming, posits that in utero environmental factors may have adverse metabolic consequences in the offspring. Thus far, however, most evidence supporting this hypothesis has come from animal studies, they cautioned.

Nevertheless, endothelial cell dysfunction is a reversible process, offering a “window of opportunity” for intervention, according to authors Karolien Van De Maele and Inge Gies, MD, of the division of pediatric endocrinology at the University Hospital of Brussels and Roland Devlieger, MD, PhD, head of fetal maternal medicine at the University Hospitals Leuven (Belgium).

“The fundamental solution to break the vicious cycle seems [to be] an intervention before or in early pregnancy,” authors said in the journal Atherosclerosis.

Mary Norine Walsh, MD, immediate past president of the American College of Cardiology, agreed with the review article’s conclusion that more evidence would be needed to show that fetal programming is implicated in the associations between maternal obesity and long-term cardiovascular effects.

“As of right now, we cannot say the offspring of pregnant women have an increased risk of cardiovascular risk in later life due to ‘X’ because those studies haven’t been done yet,” Dr. Walsh said in an interview. “So I think it’s a really good framework to think about based on the animal work that’s been done, but we have yet to identify obesity in pregnant women as an independent risk factor for vascular disease in the offspring – we just have an association.”

On the other hand, it is known that obesity increases the risk of hypertension and diabetes in both pregnant and nonpregnant women, said Dr. Walsh, and that hypertensive disorders are a leading cause of maternal morbidity and mortality.

“I think it’s really important to recognize that maternal obesity puts a woman at significant risk, and we certainly can’t forget that in the process of thinking about the offspring,” said Dr. Walsh, medical director of the heart failure and cardiac transplantation program at St. Vincent Heart Center, Indianapolis.

In the recent review article in Atherosclerosis, Ms. Van De Maele and coauthors cited evidence linking maternal obesity to adverse outcomes in offspring from a 2013 report in the BMJ that included 28,540 women in Scotland and their 37,709 offspring.

In that study, after adjustment for maternal age, socioeconomic status, and other factors, offspring of mothers who had a body mass index greater than 30 kg/m2 had higher all-cause mortality (hazard ratio, 1.35; 95% confidence interval, 1.17-1.55) and increased risk of hospital admission for a cardiovascular event (HR, 1.29; 95% CI, 1.06-1.57), compared with those whose mothers had a healthy BMI.

“Evidence from animal models and emerging data from humans suggest that maternal obesity also creates an adverse in utero environment, with long-term ‘programmed’ detrimental effects for the offspring,” the authors of that BMJ report wrote at the time.

Ms. Van De Maele and her colleagues also cited animal studies, including several looking at offspring of animals fed with a maternal high-fat diet during pregnancy. In those studies, they said, investigators observed impaired endothelial cell relaxation, along with raised thickness of the intimal wall and increased vascular inflammatory marker expression.

 

 


“Raised leptin levels, secreted by the adipose tissue, inhibit the in vitro proliferation of smooth muscle cells and could impede the angiogenesis process in vivo, but this assumption needs scientific validation in humans,” they said in their review.

However, human studies are lacking, aside from the epidemiologic reports that “cannot be used to confirm or contradict” the fetal programming hypothesis, they said.

Meanwhile, an increasing body of evidence has suggested that stressors in critical periods of fetal development may lead to epigenetic alterations that could play a role in either up-regulating atherogenic genes or down-regulating enzymatic activities that guard against oxidative stress.

For example, cohort studies have shown differences in DNA methylation among offspring born before and after bariatric surgery in the mother, which has lent credence to the hypothesis that maternal obesity in pregnancy alters methylation patterns for those offspring, Ms. Van De Maele and her colleagues wrote.

Lifestyle changes in obese pregnant women may have an effect on adverse metabolic or cardiovascular outcomes in offspring, although results to date are inconclusive, they added.

Diet, exercise, or both during pregnancy may lower the risk of macrosomia, respiratory distress syndrome, or other neonatal outcomes, particularly in high-risk women, according to the conclusions of a 2015 Cochrane review that Ms. Van De Maele and her coauthors cited.

However, follow-up studies on offspring are scarce and have shown no clear effects on long-term metabolic profiles in offspring, likely because of insufficient follow-up time, they said in their review.

Ms. Van De Maele and her coauthors said they had no conflict of interest disclosures related to their manuscript.

SOURCE: Van De Maele K et al. Atherosclerosis. 2018 Jun. doi: 10.1016/j.atherosclerosis.2018.06.016.

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Offspring of obese mothers should be regarded as a high-risk population for endothelial cell dysfunction and, therefore, for cardiovascular events later in life, authors of a thematic literature review concluded.

Maternal obesity has been tied to the development of cardiovascular disease (CVD) and premature death in epidemiologic studies, the authors noted in the review.

anopdesignstock/Thinkstock


One hypothesis, referred to as fetal programming, posits that in utero environmental factors may have adverse metabolic consequences in the offspring. Thus far, however, most evidence supporting this hypothesis has come from animal studies, they cautioned.

Nevertheless, endothelial cell dysfunction is a reversible process, offering a “window of opportunity” for intervention, according to authors Karolien Van De Maele and Inge Gies, MD, of the division of pediatric endocrinology at the University Hospital of Brussels and Roland Devlieger, MD, PhD, head of fetal maternal medicine at the University Hospitals Leuven (Belgium).

“The fundamental solution to break the vicious cycle seems [to be] an intervention before or in early pregnancy,” authors said in the journal Atherosclerosis.

Mary Norine Walsh, MD, immediate past president of the American College of Cardiology, agreed with the review article’s conclusion that more evidence would be needed to show that fetal programming is implicated in the associations between maternal obesity and long-term cardiovascular effects.

“As of right now, we cannot say the offspring of pregnant women have an increased risk of cardiovascular risk in later life due to ‘X’ because those studies haven’t been done yet,” Dr. Walsh said in an interview. “So I think it’s a really good framework to think about based on the animal work that’s been done, but we have yet to identify obesity in pregnant women as an independent risk factor for vascular disease in the offspring – we just have an association.”

On the other hand, it is known that obesity increases the risk of hypertension and diabetes in both pregnant and nonpregnant women, said Dr. Walsh, and that hypertensive disorders are a leading cause of maternal morbidity and mortality.

“I think it’s really important to recognize that maternal obesity puts a woman at significant risk, and we certainly can’t forget that in the process of thinking about the offspring,” said Dr. Walsh, medical director of the heart failure and cardiac transplantation program at St. Vincent Heart Center, Indianapolis.

In the recent review article in Atherosclerosis, Ms. Van De Maele and coauthors cited evidence linking maternal obesity to adverse outcomes in offspring from a 2013 report in the BMJ that included 28,540 women in Scotland and their 37,709 offspring.

In that study, after adjustment for maternal age, socioeconomic status, and other factors, offspring of mothers who had a body mass index greater than 30 kg/m2 had higher all-cause mortality (hazard ratio, 1.35; 95% confidence interval, 1.17-1.55) and increased risk of hospital admission for a cardiovascular event (HR, 1.29; 95% CI, 1.06-1.57), compared with those whose mothers had a healthy BMI.

“Evidence from animal models and emerging data from humans suggest that maternal obesity also creates an adverse in utero environment, with long-term ‘programmed’ detrimental effects for the offspring,” the authors of that BMJ report wrote at the time.

Ms. Van De Maele and her colleagues also cited animal studies, including several looking at offspring of animals fed with a maternal high-fat diet during pregnancy. In those studies, they said, investigators observed impaired endothelial cell relaxation, along with raised thickness of the intimal wall and increased vascular inflammatory marker expression.

 

 


“Raised leptin levels, secreted by the adipose tissue, inhibit the in vitro proliferation of smooth muscle cells and could impede the angiogenesis process in vivo, but this assumption needs scientific validation in humans,” they said in their review.

However, human studies are lacking, aside from the epidemiologic reports that “cannot be used to confirm or contradict” the fetal programming hypothesis, they said.

Meanwhile, an increasing body of evidence has suggested that stressors in critical periods of fetal development may lead to epigenetic alterations that could play a role in either up-regulating atherogenic genes or down-regulating enzymatic activities that guard against oxidative stress.

For example, cohort studies have shown differences in DNA methylation among offspring born before and after bariatric surgery in the mother, which has lent credence to the hypothesis that maternal obesity in pregnancy alters methylation patterns for those offspring, Ms. Van De Maele and her colleagues wrote.

Lifestyle changes in obese pregnant women may have an effect on adverse metabolic or cardiovascular outcomes in offspring, although results to date are inconclusive, they added.

Diet, exercise, or both during pregnancy may lower the risk of macrosomia, respiratory distress syndrome, or other neonatal outcomes, particularly in high-risk women, according to the conclusions of a 2015 Cochrane review that Ms. Van De Maele and her coauthors cited.

However, follow-up studies on offspring are scarce and have shown no clear effects on long-term metabolic profiles in offspring, likely because of insufficient follow-up time, they said in their review.

Ms. Van De Maele and her coauthors said they had no conflict of interest disclosures related to their manuscript.

SOURCE: Van De Maele K et al. Atherosclerosis. 2018 Jun. doi: 10.1016/j.atherosclerosis.2018.06.016.

 

Offspring of obese mothers should be regarded as a high-risk population for endothelial cell dysfunction and, therefore, for cardiovascular events later in life, authors of a thematic literature review concluded.

Maternal obesity has been tied to the development of cardiovascular disease (CVD) and premature death in epidemiologic studies, the authors noted in the review.

anopdesignstock/Thinkstock


One hypothesis, referred to as fetal programming, posits that in utero environmental factors may have adverse metabolic consequences in the offspring. Thus far, however, most evidence supporting this hypothesis has come from animal studies, they cautioned.

Nevertheless, endothelial cell dysfunction is a reversible process, offering a “window of opportunity” for intervention, according to authors Karolien Van De Maele and Inge Gies, MD, of the division of pediatric endocrinology at the University Hospital of Brussels and Roland Devlieger, MD, PhD, head of fetal maternal medicine at the University Hospitals Leuven (Belgium).

“The fundamental solution to break the vicious cycle seems [to be] an intervention before or in early pregnancy,” authors said in the journal Atherosclerosis.

Mary Norine Walsh, MD, immediate past president of the American College of Cardiology, agreed with the review article’s conclusion that more evidence would be needed to show that fetal programming is implicated in the associations between maternal obesity and long-term cardiovascular effects.

“As of right now, we cannot say the offspring of pregnant women have an increased risk of cardiovascular risk in later life due to ‘X’ because those studies haven’t been done yet,” Dr. Walsh said in an interview. “So I think it’s a really good framework to think about based on the animal work that’s been done, but we have yet to identify obesity in pregnant women as an independent risk factor for vascular disease in the offspring – we just have an association.”

On the other hand, it is known that obesity increases the risk of hypertension and diabetes in both pregnant and nonpregnant women, said Dr. Walsh, and that hypertensive disorders are a leading cause of maternal morbidity and mortality.

“I think it’s really important to recognize that maternal obesity puts a woman at significant risk, and we certainly can’t forget that in the process of thinking about the offspring,” said Dr. Walsh, medical director of the heart failure and cardiac transplantation program at St. Vincent Heart Center, Indianapolis.

In the recent review article in Atherosclerosis, Ms. Van De Maele and coauthors cited evidence linking maternal obesity to adverse outcomes in offspring from a 2013 report in the BMJ that included 28,540 women in Scotland and their 37,709 offspring.

In that study, after adjustment for maternal age, socioeconomic status, and other factors, offspring of mothers who had a body mass index greater than 30 kg/m2 had higher all-cause mortality (hazard ratio, 1.35; 95% confidence interval, 1.17-1.55) and increased risk of hospital admission for a cardiovascular event (HR, 1.29; 95% CI, 1.06-1.57), compared with those whose mothers had a healthy BMI.

“Evidence from animal models and emerging data from humans suggest that maternal obesity also creates an adverse in utero environment, with long-term ‘programmed’ detrimental effects for the offspring,” the authors of that BMJ report wrote at the time.

Ms. Van De Maele and her colleagues also cited animal studies, including several looking at offspring of animals fed with a maternal high-fat diet during pregnancy. In those studies, they said, investigators observed impaired endothelial cell relaxation, along with raised thickness of the intimal wall and increased vascular inflammatory marker expression.

 

 


“Raised leptin levels, secreted by the adipose tissue, inhibit the in vitro proliferation of smooth muscle cells and could impede the angiogenesis process in vivo, but this assumption needs scientific validation in humans,” they said in their review.

However, human studies are lacking, aside from the epidemiologic reports that “cannot be used to confirm or contradict” the fetal programming hypothesis, they said.

Meanwhile, an increasing body of evidence has suggested that stressors in critical periods of fetal development may lead to epigenetic alterations that could play a role in either up-regulating atherogenic genes or down-regulating enzymatic activities that guard against oxidative stress.

For example, cohort studies have shown differences in DNA methylation among offspring born before and after bariatric surgery in the mother, which has lent credence to the hypothesis that maternal obesity in pregnancy alters methylation patterns for those offspring, Ms. Van De Maele and her colleagues wrote.

Lifestyle changes in obese pregnant women may have an effect on adverse metabolic or cardiovascular outcomes in offspring, although results to date are inconclusive, they added.

Diet, exercise, or both during pregnancy may lower the risk of macrosomia, respiratory distress syndrome, or other neonatal outcomes, particularly in high-risk women, according to the conclusions of a 2015 Cochrane review that Ms. Van De Maele and her coauthors cited.

However, follow-up studies on offspring are scarce and have shown no clear effects on long-term metabolic profiles in offspring, likely because of insufficient follow-up time, they said in their review.

Ms. Van De Maele and her coauthors said they had no conflict of interest disclosures related to their manuscript.

SOURCE: Van De Maele K et al. Atherosclerosis. 2018 Jun. doi: 10.1016/j.atherosclerosis.2018.06.016.

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Preterm infant GER is a normal phenomenon

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Fri, 01/18/2019 - 17:45

 

Treatment of gastroesophageal reflux (GER) in preterm infants with traditional treatments, such as body positioning, and newer treatments with pharmacologic agents appear to be ineffective, and pharmacologic agents in particular may cause significant harm, according to a clinical report by the American Academy of Pediatrics Committee on Fetus and Newborn.

“I think that probably the most important point for any physician, including neonatologists, is that the committee concluded on the basis of the evidence that gastroesophageal reflux is a normal phenomenon that happens in almost all preterm infants,” Eric Eichenwald, MD, lead author of the committee’s clinical report and chief of neonatology at Children’s Hospital of Philadelphia, said in an interview. “So really the bottom line of the clinical report is watchful waiting, conservative management, and patience is the most important approach to a baby that you think is suffering from reflux.”

premature baby boy crying
andresr/Getty Images
Dr. Eichenwald and his associates looked at GER in preterm infants in terms of physiology, symptomatology, and diagnosis, as well as conservative and pharmacologic methods of treating them.
 

Pharmacologic management

The committee members focused on four categories of pharmacologic interventions in their report in Pediatrics.

Prokinetic (promotility) agents, such as metoclopramide, domperidone, and erythromycin, are widely used in treating symptoms of GER in older infants and appear to improve gastric emptying, reduce regurgitation, and enhance lower esophageal sphincter tone, but they do not appear to reduce GER symptoms in preterm infants. In addition to not being effective in these infants, there is also a potential for significant adverse events, including cardiac arrhythmia and neurologic side effects. Another common pharmacologic treatment is the use of sodium alginate in combination with sodium bicarbonate. In the presence of gastric acid, sodium alginate precipitates as a gel that forms a physical barrier that protects the gastric mucosa. When sodium bicarbonate is added, a carbon dioxide foam forms that is less harmful to the esophagus than GER-related fluids. While this combination treatment has reduced the number of acidic GER exposures and esophageal acid exposure in preterm infants in small studies, the long-term safety has not been evaluated in this populations.

Histamine2 (H2) blockers, like famotidine and ranitidine, also are commonly prescribed to treat preterm infant gastroesophageal reflux. H2 blockers compete with H2 for the histamine receptors of the parietal cells, which causes a decrease in hydrochloric acid and a subsequent increase in intragastric pH. These are often prescribed on the premise that GER symptoms are secondary to acid reflux in the lower esophagus, but there is no research on the efficacy of H2 blockers on the symptom profile of GER in preterm infants. This class of drugs also has been linked with an increased risk of necrotizing enterocolitis and a higher incidence of late-onset infections and death. This is thought to be caused by alteration of the intestinal microbiome, according to the clinical report.

Proton pump inhibitors (PPIs) are another treatment for reducing acid secretion by the parietal cells, but are largely ineffective in relieving clinical signs of GER in preterm infants. PPIs also have been associated with a higher risk of bacterial overgrowth, gastroenteritis, and community-acquired pneumonia in older children. It is theorized that, because of the acid mitigating effects of PPIs, they will have the potential for adverse effects similar to those seen with H2 blockers, although this has not been investigated.
 

Traditional treatments

Dr. Eichenwald also was quick to point out that even traditional methods of treating preterm infant GER are not particularly effective.

“Some of the conservative approaches that have been advocated include head-up position and different ways of side-lying to enhance emptying of the stomach after feeding. And none of those have been shown to reduce clinically appreciated signs of reflux in preterm infants. If anything – in term babies – some of those positions have been shown to increase the amount of reflux,” he said in an interview.

“I think that the other important point to make about this is that there are many signs that clinicians attribute to reflux in preterm babies, which include wakefulness, irritability, arching after a feeding. And none of those behaviors have been shown to be associated with reflux when it’s critically examined using either a pH Probe or multichannel impedance monitoring. And therefore the treatments to try to decrease reflux don’t really have an effect on those behaviors either.”
 

Parental concern

Treating a pediatric issue is not as simple as diagnosis and treatment. Often, parents are justifiably concerned about their children. Dr. Eichenwald sees educating parents as an important facet of treating GER in preterm infants.

 

 

“Quite honestly I think that there’s some projection on the part of adults who say, ‘I know how I feel when I have heartburn, which is the adult equivalent of reflux, and the baby must be experiencing the same thing, and that’s why they’re acting uncomfortable,’ ” suggested Dr. Eichenwald. “I think that it’s important for clinicians to educate families that a lot of the signs that we typically have attributed to gastroesophageal reflux are not really related to it.”

With both traditional and pharmacological interventions failing to treat preterm infant GER, Dr. Eichenwald believes that the most effective treatment could be patiently waiting. “I think that the important thing to stress is that reflux is a normal physiologic phenomenon. It rarely causes pathology in preterm infants, and therefore, in treating it, you’re not treating any pathology. You should just be patient and it will likely just go away on its own.”

Dr. Eichenwald has no potential conflicts of interest or external funding to report.

SOURCE: Eichenwald E et al. Pediatrics. 2018 June. doi: 10.1542/peds.2018-1061 .

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Treatment of gastroesophageal reflux (GER) in preterm infants with traditional treatments, such as body positioning, and newer treatments with pharmacologic agents appear to be ineffective, and pharmacologic agents in particular may cause significant harm, according to a clinical report by the American Academy of Pediatrics Committee on Fetus and Newborn.

“I think that probably the most important point for any physician, including neonatologists, is that the committee concluded on the basis of the evidence that gastroesophageal reflux is a normal phenomenon that happens in almost all preterm infants,” Eric Eichenwald, MD, lead author of the committee’s clinical report and chief of neonatology at Children’s Hospital of Philadelphia, said in an interview. “So really the bottom line of the clinical report is watchful waiting, conservative management, and patience is the most important approach to a baby that you think is suffering from reflux.”

premature baby boy crying
andresr/Getty Images
Dr. Eichenwald and his associates looked at GER in preterm infants in terms of physiology, symptomatology, and diagnosis, as well as conservative and pharmacologic methods of treating them.
 

Pharmacologic management

The committee members focused on four categories of pharmacologic interventions in their report in Pediatrics.

Prokinetic (promotility) agents, such as metoclopramide, domperidone, and erythromycin, are widely used in treating symptoms of GER in older infants and appear to improve gastric emptying, reduce regurgitation, and enhance lower esophageal sphincter tone, but they do not appear to reduce GER symptoms in preterm infants. In addition to not being effective in these infants, there is also a potential for significant adverse events, including cardiac arrhythmia and neurologic side effects. Another common pharmacologic treatment is the use of sodium alginate in combination with sodium bicarbonate. In the presence of gastric acid, sodium alginate precipitates as a gel that forms a physical barrier that protects the gastric mucosa. When sodium bicarbonate is added, a carbon dioxide foam forms that is less harmful to the esophagus than GER-related fluids. While this combination treatment has reduced the number of acidic GER exposures and esophageal acid exposure in preterm infants in small studies, the long-term safety has not been evaluated in this populations.

Histamine2 (H2) blockers, like famotidine and ranitidine, also are commonly prescribed to treat preterm infant gastroesophageal reflux. H2 blockers compete with H2 for the histamine receptors of the parietal cells, which causes a decrease in hydrochloric acid and a subsequent increase in intragastric pH. These are often prescribed on the premise that GER symptoms are secondary to acid reflux in the lower esophagus, but there is no research on the efficacy of H2 blockers on the symptom profile of GER in preterm infants. This class of drugs also has been linked with an increased risk of necrotizing enterocolitis and a higher incidence of late-onset infections and death. This is thought to be caused by alteration of the intestinal microbiome, according to the clinical report.

Proton pump inhibitors (PPIs) are another treatment for reducing acid secretion by the parietal cells, but are largely ineffective in relieving clinical signs of GER in preterm infants. PPIs also have been associated with a higher risk of bacterial overgrowth, gastroenteritis, and community-acquired pneumonia in older children. It is theorized that, because of the acid mitigating effects of PPIs, they will have the potential for adverse effects similar to those seen with H2 blockers, although this has not been investigated.
 

Traditional treatments

Dr. Eichenwald also was quick to point out that even traditional methods of treating preterm infant GER are not particularly effective.

“Some of the conservative approaches that have been advocated include head-up position and different ways of side-lying to enhance emptying of the stomach after feeding. And none of those have been shown to reduce clinically appreciated signs of reflux in preterm infants. If anything – in term babies – some of those positions have been shown to increase the amount of reflux,” he said in an interview.

“I think that the other important point to make about this is that there are many signs that clinicians attribute to reflux in preterm babies, which include wakefulness, irritability, arching after a feeding. And none of those behaviors have been shown to be associated with reflux when it’s critically examined using either a pH Probe or multichannel impedance monitoring. And therefore the treatments to try to decrease reflux don’t really have an effect on those behaviors either.”
 

Parental concern

Treating a pediatric issue is not as simple as diagnosis and treatment. Often, parents are justifiably concerned about their children. Dr. Eichenwald sees educating parents as an important facet of treating GER in preterm infants.

 

 

“Quite honestly I think that there’s some projection on the part of adults who say, ‘I know how I feel when I have heartburn, which is the adult equivalent of reflux, and the baby must be experiencing the same thing, and that’s why they’re acting uncomfortable,’ ” suggested Dr. Eichenwald. “I think that it’s important for clinicians to educate families that a lot of the signs that we typically have attributed to gastroesophageal reflux are not really related to it.”

With both traditional and pharmacological interventions failing to treat preterm infant GER, Dr. Eichenwald believes that the most effective treatment could be patiently waiting. “I think that the important thing to stress is that reflux is a normal physiologic phenomenon. It rarely causes pathology in preterm infants, and therefore, in treating it, you’re not treating any pathology. You should just be patient and it will likely just go away on its own.”

Dr. Eichenwald has no potential conflicts of interest or external funding to report.

SOURCE: Eichenwald E et al. Pediatrics. 2018 June. doi: 10.1542/peds.2018-1061 .

 

Treatment of gastroesophageal reflux (GER) in preterm infants with traditional treatments, such as body positioning, and newer treatments with pharmacologic agents appear to be ineffective, and pharmacologic agents in particular may cause significant harm, according to a clinical report by the American Academy of Pediatrics Committee on Fetus and Newborn.

“I think that probably the most important point for any physician, including neonatologists, is that the committee concluded on the basis of the evidence that gastroesophageal reflux is a normal phenomenon that happens in almost all preterm infants,” Eric Eichenwald, MD, lead author of the committee’s clinical report and chief of neonatology at Children’s Hospital of Philadelphia, said in an interview. “So really the bottom line of the clinical report is watchful waiting, conservative management, and patience is the most important approach to a baby that you think is suffering from reflux.”

premature baby boy crying
andresr/Getty Images
Dr. Eichenwald and his associates looked at GER in preterm infants in terms of physiology, symptomatology, and diagnosis, as well as conservative and pharmacologic methods of treating them.
 

Pharmacologic management

The committee members focused on four categories of pharmacologic interventions in their report in Pediatrics.

Prokinetic (promotility) agents, such as metoclopramide, domperidone, and erythromycin, are widely used in treating symptoms of GER in older infants and appear to improve gastric emptying, reduce regurgitation, and enhance lower esophageal sphincter tone, but they do not appear to reduce GER symptoms in preterm infants. In addition to not being effective in these infants, there is also a potential for significant adverse events, including cardiac arrhythmia and neurologic side effects. Another common pharmacologic treatment is the use of sodium alginate in combination with sodium bicarbonate. In the presence of gastric acid, sodium alginate precipitates as a gel that forms a physical barrier that protects the gastric mucosa. When sodium bicarbonate is added, a carbon dioxide foam forms that is less harmful to the esophagus than GER-related fluids. While this combination treatment has reduced the number of acidic GER exposures and esophageal acid exposure in preterm infants in small studies, the long-term safety has not been evaluated in this populations.

Histamine2 (H2) blockers, like famotidine and ranitidine, also are commonly prescribed to treat preterm infant gastroesophageal reflux. H2 blockers compete with H2 for the histamine receptors of the parietal cells, which causes a decrease in hydrochloric acid and a subsequent increase in intragastric pH. These are often prescribed on the premise that GER symptoms are secondary to acid reflux in the lower esophagus, but there is no research on the efficacy of H2 blockers on the symptom profile of GER in preterm infants. This class of drugs also has been linked with an increased risk of necrotizing enterocolitis and a higher incidence of late-onset infections and death. This is thought to be caused by alteration of the intestinal microbiome, according to the clinical report.

Proton pump inhibitors (PPIs) are another treatment for reducing acid secretion by the parietal cells, but are largely ineffective in relieving clinical signs of GER in preterm infants. PPIs also have been associated with a higher risk of bacterial overgrowth, gastroenteritis, and community-acquired pneumonia in older children. It is theorized that, because of the acid mitigating effects of PPIs, they will have the potential for adverse effects similar to those seen with H2 blockers, although this has not been investigated.
 

Traditional treatments

Dr. Eichenwald also was quick to point out that even traditional methods of treating preterm infant GER are not particularly effective.

“Some of the conservative approaches that have been advocated include head-up position and different ways of side-lying to enhance emptying of the stomach after feeding. And none of those have been shown to reduce clinically appreciated signs of reflux in preterm infants. If anything – in term babies – some of those positions have been shown to increase the amount of reflux,” he said in an interview.

“I think that the other important point to make about this is that there are many signs that clinicians attribute to reflux in preterm babies, which include wakefulness, irritability, arching after a feeding. And none of those behaviors have been shown to be associated with reflux when it’s critically examined using either a pH Probe or multichannel impedance monitoring. And therefore the treatments to try to decrease reflux don’t really have an effect on those behaviors either.”
 

Parental concern

Treating a pediatric issue is not as simple as diagnosis and treatment. Often, parents are justifiably concerned about their children. Dr. Eichenwald sees educating parents as an important facet of treating GER in preterm infants.

 

 

“Quite honestly I think that there’s some projection on the part of adults who say, ‘I know how I feel when I have heartburn, which is the adult equivalent of reflux, and the baby must be experiencing the same thing, and that’s why they’re acting uncomfortable,’ ” suggested Dr. Eichenwald. “I think that it’s important for clinicians to educate families that a lot of the signs that we typically have attributed to gastroesophageal reflux are not really related to it.”

With both traditional and pharmacological interventions failing to treat preterm infant GER, Dr. Eichenwald believes that the most effective treatment could be patiently waiting. “I think that the important thing to stress is that reflux is a normal physiologic phenomenon. It rarely causes pathology in preterm infants, and therefore, in treating it, you’re not treating any pathology. You should just be patient and it will likely just go away on its own.”

Dr. Eichenwald has no potential conflicts of interest or external funding to report.

SOURCE: Eichenwald E et al. Pediatrics. 2018 June. doi: 10.1542/peds.2018-1061 .

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NIH launches HEAL Initiative to combat opioid crisis

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Fri, 01/18/2019 - 17:43

 

Better treatments for opioid addiction and enhanced approaches to pain management headline a new effort to address the opioid crisis lead by the National Institutes of Health.

The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.

“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.

HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.

“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”

The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.

For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”

Dr. Francis Collins NIH

Better overdose antidotes are needed as well, he said, particularly for fentanyl overdose. “Narcan may not be strong enough for those long-lasting and very potent opioids like fentanyl,” he said.

HEAL also will seek a better understanding of neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome, which has become alarmingly common as more women of childbearing potential struggle with opioid addiction.

“Innovative methods to identify and treat newborns exposed to opioids, often along with other drugs, have the potential to improve both short- and long-term developmental outcomes in such children,” Dr. Collins and colleagues noted. “To determine better approaches, HEAL will expand Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). This pilot study is designed to assess the prevalence of NOWS, understand current approaches to managing NOWS , and develop common approaches for larger-scale studies that will determine best practices for clinical care of infants with NOWS throughout the country.”

HEAL efforts also seek to find integrated approaches to OUD treatment.

“One particularly bold element is to put together a number of pilot projects that enable bringing together all of the ways in which we are trying to turn this epidemic around by making it possible to assess whether individuals who are addicted can be successfully treated and maintained in abstinence for long periods of time,” Dr. Collins said. “Right now, the success is not so great.

“Suppose we brought together all of the treatment programs – the primary care facilities, the emergency rooms, the fire departments, the social work experts, the health departments in the states, the local communities, the criminal justice system. We brought together all of those players in a research design where we can really see what was working. Could we do a lot more to turn this around than basically doing one of those at a time? There is this multisite idea of a national research effort, still somewhat in development, but to do integration of all of these efforts. I am pretty excited about that one.”

In looking for better ways to treat pain safely and effectively, “we need to understand how it is that people transition from acute pain to chronic pain … and what can we do increase the likelihood of recovery from acute pain without making that transition,” Dr. Collins said. “Then we need to identify additional novel targets for developing pain therapies, both devices and pharmaceuticals. We need better means of testing those ideas.”

In addition to gaining a better understanding of chronic pain, HEAL aims to investigate new nonaddictive pain treatments and find ways to expedite those treatments through the clinical pipeline, according to Dr. Collins and colleagues.

HEAL “lays the foundation for an innovative therapy-development pipeline through a planned new public-private partnership. In collaboration with biopharmaceutical groups, the Food and Drug Administration, and the Foundation for the NIH, the NIH will collect and evaluate treatment assets from academia and biopharmaceutical and device companies to coordinate and accelerate the development of effective treatments for pain and addiction,” they wrote.
 

gtwachtman@mdedge.com
 

SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.

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Better treatments for opioid addiction and enhanced approaches to pain management headline a new effort to address the opioid crisis lead by the National Institutes of Health.

The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.

“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.

HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.

“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”

The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.

For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”

Dr. Francis Collins NIH

Better overdose antidotes are needed as well, he said, particularly for fentanyl overdose. “Narcan may not be strong enough for those long-lasting and very potent opioids like fentanyl,” he said.

HEAL also will seek a better understanding of neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome, which has become alarmingly common as more women of childbearing potential struggle with opioid addiction.

“Innovative methods to identify and treat newborns exposed to opioids, often along with other drugs, have the potential to improve both short- and long-term developmental outcomes in such children,” Dr. Collins and colleagues noted. “To determine better approaches, HEAL will expand Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). This pilot study is designed to assess the prevalence of NOWS, understand current approaches to managing NOWS , and develop common approaches for larger-scale studies that will determine best practices for clinical care of infants with NOWS throughout the country.”

HEAL efforts also seek to find integrated approaches to OUD treatment.

“One particularly bold element is to put together a number of pilot projects that enable bringing together all of the ways in which we are trying to turn this epidemic around by making it possible to assess whether individuals who are addicted can be successfully treated and maintained in abstinence for long periods of time,” Dr. Collins said. “Right now, the success is not so great.

“Suppose we brought together all of the treatment programs – the primary care facilities, the emergency rooms, the fire departments, the social work experts, the health departments in the states, the local communities, the criminal justice system. We brought together all of those players in a research design where we can really see what was working. Could we do a lot more to turn this around than basically doing one of those at a time? There is this multisite idea of a national research effort, still somewhat in development, but to do integration of all of these efforts. I am pretty excited about that one.”

In looking for better ways to treat pain safely and effectively, “we need to understand how it is that people transition from acute pain to chronic pain … and what can we do increase the likelihood of recovery from acute pain without making that transition,” Dr. Collins said. “Then we need to identify additional novel targets for developing pain therapies, both devices and pharmaceuticals. We need better means of testing those ideas.”

In addition to gaining a better understanding of chronic pain, HEAL aims to investigate new nonaddictive pain treatments and find ways to expedite those treatments through the clinical pipeline, according to Dr. Collins and colleagues.

HEAL “lays the foundation for an innovative therapy-development pipeline through a planned new public-private partnership. In collaboration with biopharmaceutical groups, the Food and Drug Administration, and the Foundation for the NIH, the NIH will collect and evaluate treatment assets from academia and biopharmaceutical and device companies to coordinate and accelerate the development of effective treatments for pain and addiction,” they wrote.
 

gtwachtman@mdedge.com
 

SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.

 

Better treatments for opioid addiction and enhanced approaches to pain management headline a new effort to address the opioid crisis lead by the National Institutes of Health.

The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.

“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.

HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.

“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”

The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.

For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”

Dr. Francis Collins NIH

Better overdose antidotes are needed as well, he said, particularly for fentanyl overdose. “Narcan may not be strong enough for those long-lasting and very potent opioids like fentanyl,” he said.

HEAL also will seek a better understanding of neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome, which has become alarmingly common as more women of childbearing potential struggle with opioid addiction.

“Innovative methods to identify and treat newborns exposed to opioids, often along with other drugs, have the potential to improve both short- and long-term developmental outcomes in such children,” Dr. Collins and colleagues noted. “To determine better approaches, HEAL will expand Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). This pilot study is designed to assess the prevalence of NOWS, understand current approaches to managing NOWS , and develop common approaches for larger-scale studies that will determine best practices for clinical care of infants with NOWS throughout the country.”

HEAL efforts also seek to find integrated approaches to OUD treatment.

“One particularly bold element is to put together a number of pilot projects that enable bringing together all of the ways in which we are trying to turn this epidemic around by making it possible to assess whether individuals who are addicted can be successfully treated and maintained in abstinence for long periods of time,” Dr. Collins said. “Right now, the success is not so great.

“Suppose we brought together all of the treatment programs – the primary care facilities, the emergency rooms, the fire departments, the social work experts, the health departments in the states, the local communities, the criminal justice system. We brought together all of those players in a research design where we can really see what was working. Could we do a lot more to turn this around than basically doing one of those at a time? There is this multisite idea of a national research effort, still somewhat in development, but to do integration of all of these efforts. I am pretty excited about that one.”

In looking for better ways to treat pain safely and effectively, “we need to understand how it is that people transition from acute pain to chronic pain … and what can we do increase the likelihood of recovery from acute pain without making that transition,” Dr. Collins said. “Then we need to identify additional novel targets for developing pain therapies, both devices and pharmaceuticals. We need better means of testing those ideas.”

In addition to gaining a better understanding of chronic pain, HEAL aims to investigate new nonaddictive pain treatments and find ways to expedite those treatments through the clinical pipeline, according to Dr. Collins and colleagues.

HEAL “lays the foundation for an innovative therapy-development pipeline through a planned new public-private partnership. In collaboration with biopharmaceutical groups, the Food and Drug Administration, and the Foundation for the NIH, the NIH will collect and evaluate treatment assets from academia and biopharmaceutical and device companies to coordinate and accelerate the development of effective treatments for pain and addiction,” they wrote.
 

gtwachtman@mdedge.com
 

SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.

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App found to improve quality of life for families of premature infants

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– Significant improvement in quality of life was observed in neonatal ICU families using the PreeMe+You app, preliminary results from a two-center study showed.

“NICU time is stressful,” one of the study authors, Abigail Whitney, said at the Pediatric Academic Societies annual meeting. “With the birth of a preterm infant, parents are often quickly transitioned into the role of becoming a parent much sooner and in much different circumstances than they might have anticipated. Parents have reported feelings of isolation, alienation, and insecurity in the parental role while in the NICU. Studies have shown that interventions that engage parents in their infant’s progress can decrease parental stress and anxiety, increase positive parent-infant interaction, and even reduce the infant’s length of stay. Also, with advancing technology there has been a push to find ways to use mobile technology to help parents balance engaging with their infant with the rest of their busy lives.”

Newborn baby in incubator
Metin Kiyak/Thinkstock
Newborn baby in incubator
One such technology, the PreeMe+You app, was created by a social benefit health startup of the same name to help parents follow the progress of their infant while in the NICU and to help them engage at the bedside, said Ms. Whitney, a second-year medical student at the University of Chicago. The app centers on a maturation framework using a proprietary neonatal algorithm that follows the baby’s medical progress in five different categories: breathing, sleeping, eating, temperature, and growth. It assigns the baby one of four colors in each of these categories based on the baby’s current medical state. Purple represents the highest acuity and the longest time to go in the NICU, while yellow represents the closest to discharge. “Babies may begin at different colors in each of the different categories, but the eventual progression is purple to blue to orange to yellow,” Ms. Whitney said. “The idea is, once you have a full yellow circle you’re almost ready to go home.”

In a study overseen by PreeMe+You’s chief medical expert, Bree Andrews, MD, MPH, Ms. Whitney and her associates administered the app to 48 families at either the University of Chicago Medicine Comer Children’s Hospital NICU or the Evanston Hospital NICU to assess readiness for using mobile technologies at the bedside. All families were recommended by a child life specialist who identified families who might be interested in using something like PreeMe+You. They excluded any families that were currently involved with child and family services, those with an infant younger than 7 days old, those whose child required escalation of care or upcoming surgeries, and those whose infant was over 37 weeks’ gestation.

First, the researchers briefed NICU staff about the study at charge nurse meetings, faculty meetings, and daily huddles for 2 weeks before first enrollment. “We did this knowing that parents might go to their nurses or doctors about how to answer specific questions within the app, or maybe want to learn more about a certain topic they learned from PreeMe+You,” Ms. Whitney said.

Data measurements included the PreeMe+You composite survey, which pulled questions from the Fragile Infant Parent Readiness Evaluation (FIPRE) and the NICU Parent Risk Evaluation and Engagement Model and Instrument (PREEMI). “We also included additional questions about technology use and capacity, as well as the PedsQL [Pediatric Quality of Life Inventory] Family Impact Module to assess parental quality of life throughout the study,” she said.

Abigail Whitney, University of Chicago, Pritzker School of Medicine
Abigail Whitney
At study enrollment, the researchers asked families to complete both the PreeMe+You composite survey and the PedsQL Family Impact Module. “They created a PreeMe+You login and we would help them engage with the app and tell them what it was all about,” Ms. Whitney explained. “Follow-up occurred about once a week or based on parent availability. At each follow-up, they would reengage with the PreeMe+You App if they hadn’t updated the questions recently. We also would readminister the PedQL Family Impact Module survey.” Study closure occurred either by parental choice or by upcoming discharge, at which time they would engage with PreeMe+You one last time, and repeat the PreeMe+You composite survey and the PedQL Family Impact Module survey.

 

 


Over a period of 9 months, the researchers collected 153 quality of life measurements from 48 families. Of these, 48 occurred at enrollment, 23 occurred less than 1 week after enrollment, 30 occurred 1-2 weeks after enrollment, 28 occurred 3-4 weeks after enrollment, and 24 occurred 4 weeks or more after enrollment. By study closure, the researchers had follow-up data on 44 of the 48 families. The average gestational age at birth was 29.3 weeks, the average day of life at enrollment was 25.4, and the average birth weight was 1,280 grams.

On the app’s composite survey, 14.6% “agreed” and 79.2% “strongly agreed” that they were currently using a smart phone or tablet to look for information about preemies/NICU on the Internet, and about half “agreed” or “strongly agreed” (27.1% and 33.3%, respectively) that they spent more than 30 minutes per week looking up information about their NICU baby online. Nearly all families “agreed” or “strongly agreed” (14.6% and 85.4%) that they had a smart phone or tablet for Internet use in the NICU, and nearly all “agreed” or “strongly agreed” (33.3% and 62.5%) that having an app at the NICU bedside/home would be helpful. “This showed us that families were ready to use technology and interested in something like PreeMe+You at the bedside,” Ms. Whitney said.



At the time of study enrollment, 12 were in the purple stage, 8 were in the blue stage, 19 infants were in the orange stage, and 9 were in the yellow stage. Ms. Whitney reported that based on the PedsQL Family Impact Module, 35 of the 44 families showed increased quality of life functionality after participating in the study. This change was significant, with a P value of .001. Improvements were seen in the measure’s eight domains (physical, emotional, social, cognitive, communication, worry, daily activities, and family relationship functionality). “We saw increases across all of the domains based on how long the parents had been using the app,” Ms. Whitney said. “We found the biggest increase in quality of life in families of babies born less than 25 weeks’ gestational age, those born 25-26 weeks gestational age, those born 27-28 weeks gestational age, and those born 33-37 weeks gestational age. We are encouraged to see some of these quality of life changes in some of the earliest-born gestation babies because these are presumably the families that would have the longest time to go in the NICU and could benefit the most from using an app like PreeMe+You.”

She acknowledged certain limitations of the study, including the fact that it was conducted in two NICUs, “and we definitely need more comparisons to look at the natural trajectory of quality of life changes while families are in the NICU. Also, all of the families enrolled in our study had access to a research team that checked in with them weekly. In the real world, PreeMe+You would probably be self-guided.” Going forward, PreeMe+You plans to include additional features to give parents more self-guidance, making it easier for them to interact and partner with their baby’s medical team.

Funding for the study was provided by the Bucksbaum Institute for Clinical Excellence. Ms. Whitney was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.

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– Significant improvement in quality of life was observed in neonatal ICU families using the PreeMe+You app, preliminary results from a two-center study showed.

“NICU time is stressful,” one of the study authors, Abigail Whitney, said at the Pediatric Academic Societies annual meeting. “With the birth of a preterm infant, parents are often quickly transitioned into the role of becoming a parent much sooner and in much different circumstances than they might have anticipated. Parents have reported feelings of isolation, alienation, and insecurity in the parental role while in the NICU. Studies have shown that interventions that engage parents in their infant’s progress can decrease parental stress and anxiety, increase positive parent-infant interaction, and even reduce the infant’s length of stay. Also, with advancing technology there has been a push to find ways to use mobile technology to help parents balance engaging with their infant with the rest of their busy lives.”

Newborn baby in incubator
Metin Kiyak/Thinkstock
Newborn baby in incubator
One such technology, the PreeMe+You app, was created by a social benefit health startup of the same name to help parents follow the progress of their infant while in the NICU and to help them engage at the bedside, said Ms. Whitney, a second-year medical student at the University of Chicago. The app centers on a maturation framework using a proprietary neonatal algorithm that follows the baby’s medical progress in five different categories: breathing, sleeping, eating, temperature, and growth. It assigns the baby one of four colors in each of these categories based on the baby’s current medical state. Purple represents the highest acuity and the longest time to go in the NICU, while yellow represents the closest to discharge. “Babies may begin at different colors in each of the different categories, but the eventual progression is purple to blue to orange to yellow,” Ms. Whitney said. “The idea is, once you have a full yellow circle you’re almost ready to go home.”

In a study overseen by PreeMe+You’s chief medical expert, Bree Andrews, MD, MPH, Ms. Whitney and her associates administered the app to 48 families at either the University of Chicago Medicine Comer Children’s Hospital NICU or the Evanston Hospital NICU to assess readiness for using mobile technologies at the bedside. All families were recommended by a child life specialist who identified families who might be interested in using something like PreeMe+You. They excluded any families that were currently involved with child and family services, those with an infant younger than 7 days old, those whose child required escalation of care or upcoming surgeries, and those whose infant was over 37 weeks’ gestation.

First, the researchers briefed NICU staff about the study at charge nurse meetings, faculty meetings, and daily huddles for 2 weeks before first enrollment. “We did this knowing that parents might go to their nurses or doctors about how to answer specific questions within the app, or maybe want to learn more about a certain topic they learned from PreeMe+You,” Ms. Whitney said.

Data measurements included the PreeMe+You composite survey, which pulled questions from the Fragile Infant Parent Readiness Evaluation (FIPRE) and the NICU Parent Risk Evaluation and Engagement Model and Instrument (PREEMI). “We also included additional questions about technology use and capacity, as well as the PedsQL [Pediatric Quality of Life Inventory] Family Impact Module to assess parental quality of life throughout the study,” she said.

Abigail Whitney, University of Chicago, Pritzker School of Medicine
Abigail Whitney
At study enrollment, the researchers asked families to complete both the PreeMe+You composite survey and the PedsQL Family Impact Module. “They created a PreeMe+You login and we would help them engage with the app and tell them what it was all about,” Ms. Whitney explained. “Follow-up occurred about once a week or based on parent availability. At each follow-up, they would reengage with the PreeMe+You App if they hadn’t updated the questions recently. We also would readminister the PedQL Family Impact Module survey.” Study closure occurred either by parental choice or by upcoming discharge, at which time they would engage with PreeMe+You one last time, and repeat the PreeMe+You composite survey and the PedQL Family Impact Module survey.

 

 


Over a period of 9 months, the researchers collected 153 quality of life measurements from 48 families. Of these, 48 occurred at enrollment, 23 occurred less than 1 week after enrollment, 30 occurred 1-2 weeks after enrollment, 28 occurred 3-4 weeks after enrollment, and 24 occurred 4 weeks or more after enrollment. By study closure, the researchers had follow-up data on 44 of the 48 families. The average gestational age at birth was 29.3 weeks, the average day of life at enrollment was 25.4, and the average birth weight was 1,280 grams.

On the app’s composite survey, 14.6% “agreed” and 79.2% “strongly agreed” that they were currently using a smart phone or tablet to look for information about preemies/NICU on the Internet, and about half “agreed” or “strongly agreed” (27.1% and 33.3%, respectively) that they spent more than 30 minutes per week looking up information about their NICU baby online. Nearly all families “agreed” or “strongly agreed” (14.6% and 85.4%) that they had a smart phone or tablet for Internet use in the NICU, and nearly all “agreed” or “strongly agreed” (33.3% and 62.5%) that having an app at the NICU bedside/home would be helpful. “This showed us that families were ready to use technology and interested in something like PreeMe+You at the bedside,” Ms. Whitney said.



At the time of study enrollment, 12 were in the purple stage, 8 were in the blue stage, 19 infants were in the orange stage, and 9 were in the yellow stage. Ms. Whitney reported that based on the PedsQL Family Impact Module, 35 of the 44 families showed increased quality of life functionality after participating in the study. This change was significant, with a P value of .001. Improvements were seen in the measure’s eight domains (physical, emotional, social, cognitive, communication, worry, daily activities, and family relationship functionality). “We saw increases across all of the domains based on how long the parents had been using the app,” Ms. Whitney said. “We found the biggest increase in quality of life in families of babies born less than 25 weeks’ gestational age, those born 25-26 weeks gestational age, those born 27-28 weeks gestational age, and those born 33-37 weeks gestational age. We are encouraged to see some of these quality of life changes in some of the earliest-born gestation babies because these are presumably the families that would have the longest time to go in the NICU and could benefit the most from using an app like PreeMe+You.”

She acknowledged certain limitations of the study, including the fact that it was conducted in two NICUs, “and we definitely need more comparisons to look at the natural trajectory of quality of life changes while families are in the NICU. Also, all of the families enrolled in our study had access to a research team that checked in with them weekly. In the real world, PreeMe+You would probably be self-guided.” Going forward, PreeMe+You plans to include additional features to give parents more self-guidance, making it easier for them to interact and partner with their baby’s medical team.

Funding for the study was provided by the Bucksbaum Institute for Clinical Excellence. Ms. Whitney was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.

 

– Significant improvement in quality of life was observed in neonatal ICU families using the PreeMe+You app, preliminary results from a two-center study showed.

“NICU time is stressful,” one of the study authors, Abigail Whitney, said at the Pediatric Academic Societies annual meeting. “With the birth of a preterm infant, parents are often quickly transitioned into the role of becoming a parent much sooner and in much different circumstances than they might have anticipated. Parents have reported feelings of isolation, alienation, and insecurity in the parental role while in the NICU. Studies have shown that interventions that engage parents in their infant’s progress can decrease parental stress and anxiety, increase positive parent-infant interaction, and even reduce the infant’s length of stay. Also, with advancing technology there has been a push to find ways to use mobile technology to help parents balance engaging with their infant with the rest of their busy lives.”

Newborn baby in incubator
Metin Kiyak/Thinkstock
Newborn baby in incubator
One such technology, the PreeMe+You app, was created by a social benefit health startup of the same name to help parents follow the progress of their infant while in the NICU and to help them engage at the bedside, said Ms. Whitney, a second-year medical student at the University of Chicago. The app centers on a maturation framework using a proprietary neonatal algorithm that follows the baby’s medical progress in five different categories: breathing, sleeping, eating, temperature, and growth. It assigns the baby one of four colors in each of these categories based on the baby’s current medical state. Purple represents the highest acuity and the longest time to go in the NICU, while yellow represents the closest to discharge. “Babies may begin at different colors in each of the different categories, but the eventual progression is purple to blue to orange to yellow,” Ms. Whitney said. “The idea is, once you have a full yellow circle you’re almost ready to go home.”

In a study overseen by PreeMe+You’s chief medical expert, Bree Andrews, MD, MPH, Ms. Whitney and her associates administered the app to 48 families at either the University of Chicago Medicine Comer Children’s Hospital NICU or the Evanston Hospital NICU to assess readiness for using mobile technologies at the bedside. All families were recommended by a child life specialist who identified families who might be interested in using something like PreeMe+You. They excluded any families that were currently involved with child and family services, those with an infant younger than 7 days old, those whose child required escalation of care or upcoming surgeries, and those whose infant was over 37 weeks’ gestation.

First, the researchers briefed NICU staff about the study at charge nurse meetings, faculty meetings, and daily huddles for 2 weeks before first enrollment. “We did this knowing that parents might go to their nurses or doctors about how to answer specific questions within the app, or maybe want to learn more about a certain topic they learned from PreeMe+You,” Ms. Whitney said.

Data measurements included the PreeMe+You composite survey, which pulled questions from the Fragile Infant Parent Readiness Evaluation (FIPRE) and the NICU Parent Risk Evaluation and Engagement Model and Instrument (PREEMI). “We also included additional questions about technology use and capacity, as well as the PedsQL [Pediatric Quality of Life Inventory] Family Impact Module to assess parental quality of life throughout the study,” she said.

Abigail Whitney, University of Chicago, Pritzker School of Medicine
Abigail Whitney
At study enrollment, the researchers asked families to complete both the PreeMe+You composite survey and the PedsQL Family Impact Module. “They created a PreeMe+You login and we would help them engage with the app and tell them what it was all about,” Ms. Whitney explained. “Follow-up occurred about once a week or based on parent availability. At each follow-up, they would reengage with the PreeMe+You App if they hadn’t updated the questions recently. We also would readminister the PedQL Family Impact Module survey.” Study closure occurred either by parental choice or by upcoming discharge, at which time they would engage with PreeMe+You one last time, and repeat the PreeMe+You composite survey and the PedQL Family Impact Module survey.

 

 


Over a period of 9 months, the researchers collected 153 quality of life measurements from 48 families. Of these, 48 occurred at enrollment, 23 occurred less than 1 week after enrollment, 30 occurred 1-2 weeks after enrollment, 28 occurred 3-4 weeks after enrollment, and 24 occurred 4 weeks or more after enrollment. By study closure, the researchers had follow-up data on 44 of the 48 families. The average gestational age at birth was 29.3 weeks, the average day of life at enrollment was 25.4, and the average birth weight was 1,280 grams.

On the app’s composite survey, 14.6% “agreed” and 79.2% “strongly agreed” that they were currently using a smart phone or tablet to look for information about preemies/NICU on the Internet, and about half “agreed” or “strongly agreed” (27.1% and 33.3%, respectively) that they spent more than 30 minutes per week looking up information about their NICU baby online. Nearly all families “agreed” or “strongly agreed” (14.6% and 85.4%) that they had a smart phone or tablet for Internet use in the NICU, and nearly all “agreed” or “strongly agreed” (33.3% and 62.5%) that having an app at the NICU bedside/home would be helpful. “This showed us that families were ready to use technology and interested in something like PreeMe+You at the bedside,” Ms. Whitney said.



At the time of study enrollment, 12 were in the purple stage, 8 were in the blue stage, 19 infants were in the orange stage, and 9 were in the yellow stage. Ms. Whitney reported that based on the PedsQL Family Impact Module, 35 of the 44 families showed increased quality of life functionality after participating in the study. This change was significant, with a P value of .001. Improvements were seen in the measure’s eight domains (physical, emotional, social, cognitive, communication, worry, daily activities, and family relationship functionality). “We saw increases across all of the domains based on how long the parents had been using the app,” Ms. Whitney said. “We found the biggest increase in quality of life in families of babies born less than 25 weeks’ gestational age, those born 25-26 weeks gestational age, those born 27-28 weeks gestational age, and those born 33-37 weeks gestational age. We are encouraged to see some of these quality of life changes in some of the earliest-born gestation babies because these are presumably the families that would have the longest time to go in the NICU and could benefit the most from using an app like PreeMe+You.”

She acknowledged certain limitations of the study, including the fact that it was conducted in two NICUs, “and we definitely need more comparisons to look at the natural trajectory of quality of life changes while families are in the NICU. Also, all of the families enrolled in our study had access to a research team that checked in with them weekly. In the real world, PreeMe+You would probably be self-guided.” Going forward, PreeMe+You plans to include additional features to give parents more self-guidance, making it easier for them to interact and partner with their baby’s medical team.

Funding for the study was provided by the Bucksbaum Institute for Clinical Excellence. Ms. Whitney was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.

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Key clinical point: Parents generally embraced the idea of an app to provide education and engage them at the bedside of their premature infant.

Major finding: In all, 35 of the 44 families showed increased quality of life functionality, based on the PedsQL Family Impact Module (P = .001).

Study details: A two-center study of 44 families with premature infants intended to assess readiness for using mobile technologies at the bedside.

Disclosures: Funding for the study was provided by the Bucksbaum Institute for Clinical Excellence. Ms. Whitney was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.

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Neonatal deaths lower in high-volume hospitals

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– A first look at the timing of neonatal deaths showed an association with weekend deliveries in one Texas county. However, birth weight and ethnicity attenuated the association, according to a recent study. Higher hospital volumes were associated with lower risk of neonatal deaths.

The retrospective, population-based cohort study, presented during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, used data from birth certificates and infant death certificates in the state of Texas. The investigators, said Elizabeth Restrepo, PhD, chose to examine data from Tarrant County, Tex., which has historically had persistently high infant mortality rates; in 2013, she said, the infant mortality rate in that county was 7.11/1,000 births – the highest in the state for that year.

The first question Dr. Restrepo and her colleagues at Texas Women’s University, Denton, wanted to answer was whether there was an association between the risk of neonatal mortality and the day of the week of the birth. For this and the study’s other research questions, she and her colleagues looked at 2012 data, matching 32,140 birth certificate records with 92 infant death certificates.

The investigators found an independent association between the risk of neonatal death and whether the birth happened on a weekday (Monday at 7:00 a.m. through Friday at 6:59 p.m.), or on a weekend (Friday at 7:00 p.m. through Monday at 6:59 a.m.). However, once birth weight and ethnicity were controlled in the statistical analysis, the association was not statistically significant despite an odds ratio of 1.44 (95% confidence interval, 0.911-2.27; P = .119).

“Births in the 12 hospitals studied appear to have been organized to take place more frequently on the working weekday rather than weekend days,” wrote Dr. Restrepo and her colleagues in the poster accompanying the presentation. Although the study wasn’t designed to answer this particular question, Dr. Restrepo said in discussion during the poster session that planned deliveries, such as inductions and cesarean deliveries, are likely to happen during the week, while the case mix is wider on weekends. Patient characteristics, as well as staffing patterns, may come into play.

The researchers also asked whether birth volume at a given institution increases the odds of neonatal death on weekends. Here, they found a significant inverse relationship between hospital birth volume and neonatal deaths (r = –0.021; P less than .001). With each additional increase of 1% in the weekday birth rate, the odds of neonatal death dropped by approximately 7.4%.

Examining the Tarrant County data further, Dr. Restrepo and her colleagues found that the hospitals with higher birth volumes had a more even distribution of births across the days of the week, with resulting lower concentrations of births during the week (r = –.394; P less than .001).

 

 


To classify infant deaths, the investigators included only ICD-10 diagnoses classified as P-codes to capture deaths occurring in the first 28 days after birth, but excluding congenital problems that are incompatible with life or that usually cause early death.

The researchers reported that they had no conflicts of interest; the study was funded by a research enhancement program award from the Texas Women’s University Office of Research and Sponsored Programs.
 

SOURCE: Restrepo E et al. ACOG 2018, Abstract 22R.

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– A first look at the timing of neonatal deaths showed an association with weekend deliveries in one Texas county. However, birth weight and ethnicity attenuated the association, according to a recent study. Higher hospital volumes were associated with lower risk of neonatal deaths.

The retrospective, population-based cohort study, presented during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, used data from birth certificates and infant death certificates in the state of Texas. The investigators, said Elizabeth Restrepo, PhD, chose to examine data from Tarrant County, Tex., which has historically had persistently high infant mortality rates; in 2013, she said, the infant mortality rate in that county was 7.11/1,000 births – the highest in the state for that year.

The first question Dr. Restrepo and her colleagues at Texas Women’s University, Denton, wanted to answer was whether there was an association between the risk of neonatal mortality and the day of the week of the birth. For this and the study’s other research questions, she and her colleagues looked at 2012 data, matching 32,140 birth certificate records with 92 infant death certificates.

The investigators found an independent association between the risk of neonatal death and whether the birth happened on a weekday (Monday at 7:00 a.m. through Friday at 6:59 p.m.), or on a weekend (Friday at 7:00 p.m. through Monday at 6:59 a.m.). However, once birth weight and ethnicity were controlled in the statistical analysis, the association was not statistically significant despite an odds ratio of 1.44 (95% confidence interval, 0.911-2.27; P = .119).

“Births in the 12 hospitals studied appear to have been organized to take place more frequently on the working weekday rather than weekend days,” wrote Dr. Restrepo and her colleagues in the poster accompanying the presentation. Although the study wasn’t designed to answer this particular question, Dr. Restrepo said in discussion during the poster session that planned deliveries, such as inductions and cesarean deliveries, are likely to happen during the week, while the case mix is wider on weekends. Patient characteristics, as well as staffing patterns, may come into play.

The researchers also asked whether birth volume at a given institution increases the odds of neonatal death on weekends. Here, they found a significant inverse relationship between hospital birth volume and neonatal deaths (r = –0.021; P less than .001). With each additional increase of 1% in the weekday birth rate, the odds of neonatal death dropped by approximately 7.4%.

Examining the Tarrant County data further, Dr. Restrepo and her colleagues found that the hospitals with higher birth volumes had a more even distribution of births across the days of the week, with resulting lower concentrations of births during the week (r = –.394; P less than .001).

 

 


To classify infant deaths, the investigators included only ICD-10 diagnoses classified as P-codes to capture deaths occurring in the first 28 days after birth, but excluding congenital problems that are incompatible with life or that usually cause early death.

The researchers reported that they had no conflicts of interest; the study was funded by a research enhancement program award from the Texas Women’s University Office of Research and Sponsored Programs.
 

SOURCE: Restrepo E et al. ACOG 2018, Abstract 22R.

 

– A first look at the timing of neonatal deaths showed an association with weekend deliveries in one Texas county. However, birth weight and ethnicity attenuated the association, according to a recent study. Higher hospital volumes were associated with lower risk of neonatal deaths.

The retrospective, population-based cohort study, presented during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, used data from birth certificates and infant death certificates in the state of Texas. The investigators, said Elizabeth Restrepo, PhD, chose to examine data from Tarrant County, Tex., which has historically had persistently high infant mortality rates; in 2013, she said, the infant mortality rate in that county was 7.11/1,000 births – the highest in the state for that year.

The first question Dr. Restrepo and her colleagues at Texas Women’s University, Denton, wanted to answer was whether there was an association between the risk of neonatal mortality and the day of the week of the birth. For this and the study’s other research questions, she and her colleagues looked at 2012 data, matching 32,140 birth certificate records with 92 infant death certificates.

The investigators found an independent association between the risk of neonatal death and whether the birth happened on a weekday (Monday at 7:00 a.m. through Friday at 6:59 p.m.), or on a weekend (Friday at 7:00 p.m. through Monday at 6:59 a.m.). However, once birth weight and ethnicity were controlled in the statistical analysis, the association was not statistically significant despite an odds ratio of 1.44 (95% confidence interval, 0.911-2.27; P = .119).

“Births in the 12 hospitals studied appear to have been organized to take place more frequently on the working weekday rather than weekend days,” wrote Dr. Restrepo and her colleagues in the poster accompanying the presentation. Although the study wasn’t designed to answer this particular question, Dr. Restrepo said in discussion during the poster session that planned deliveries, such as inductions and cesarean deliveries, are likely to happen during the week, while the case mix is wider on weekends. Patient characteristics, as well as staffing patterns, may come into play.

The researchers also asked whether birth volume at a given institution increases the odds of neonatal death on weekends. Here, they found a significant inverse relationship between hospital birth volume and neonatal deaths (r = –0.021; P less than .001). With each additional increase of 1% in the weekday birth rate, the odds of neonatal death dropped by approximately 7.4%.

Examining the Tarrant County data further, Dr. Restrepo and her colleagues found that the hospitals with higher birth volumes had a more even distribution of births across the days of the week, with resulting lower concentrations of births during the week (r = –.394; P less than .001).

 

 


To classify infant deaths, the investigators included only ICD-10 diagnoses classified as P-codes to capture deaths occurring in the first 28 days after birth, but excluding congenital problems that are incompatible with life or that usually cause early death.

The researchers reported that they had no conflicts of interest; the study was funded by a research enhancement program award from the Texas Women’s University Office of Research and Sponsored Programs.
 

SOURCE: Restrepo E et al. ACOG 2018, Abstract 22R.

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Key clinical point: Neonatal deaths were lower in hospitals with higher delivery volumes.

Major finding: Higher weekday birth volumes were associated with lower risk of neonatal death (P = .002).

Study details: Retrospective cohort study of 92 neonatal deaths in a single Texas county in 2012.

Disclosures: The study was funded by Texas Women’s University. The authors reported that they had no relevant disclosures.

Source: Restrepo E et al. ACOG 2018, Abstract 22R.

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Jump start immunizations in NICU

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Fri, 01/18/2019 - 17:42

 

– The neonatal intensive care unit often represents a lost opportunity to bring an infant fully up to date for recommended age-appropriate immunizations– but it needn’t be that way, Raymond C. Stetson, MD, declared at the annual meeting of the European Society for Paediatric Infectious Diseases.

Dr. Raymond Stetson of the Mayo Clinic, Rochester, Minn.
Bruce Jancin/MDedge News
Dr. Raymond Stetson
He cited as a case in point the dramatic turnaround accomplished at the 26-bed NICU at the Mayo Clinic in Rochester, Minn., where he is a neonatal medicine fellow. When he and his coinvestigators conducted an electronic health record audit, they determined that only 56% of the 754 NICU patients cared for from 2015 through mid-2017 were fully up to date for the Advisory Committee on Immunization Practices-recommended vaccinations, excluding rotavirus vaccination, at the time of discharge or transfer. After developing and implementing an action plan, however, the on-time immunization rate jumped to 94% in the 155 patients discharged during the first 6 months of the new program.

“We were able to find that within our unit a small number of quality improvement measures enabled us to drastically increase our vaccination rate in this population. I think this shows that other units ought to be auditing their immunization rates, and if they find similar root causes of low rates our experience could be generalized to those units as well,” Dr. Stetson said.

It’s well established that premature infants are at increased risk for underimmunization. Dr. Stetson and his coinvestigators deemed the baseline 56% on-time immunization rate in their NICU patients to be unacceptable, because underimmunized infants are more vulnerable to vaccine-preventable illnesses after discharge. So using the quality improvement methodology known as DMAIC – for Define, Measure, Analyze, Improve, Control – the investigators surveyed Mayo NICU physicians and nurses and identified three root causes of the quality gap: lack of staff knowledge of the routine immunization schedule, lack of awareness of when a NICU patient’s vaccines were actually due, and parental vaccine hesitancy.

Newborn baby in incubator
copyright Metin Kiyak/Thinkstock
Newborn baby in incubator
Dr. Stetson and his coworkers then introduced three quality improvement measures: They provided easy Intranet access to the Advisory Committee on Immunization Practices (ACIP) routine immunization schedule, plus an Excel-based checklist that automatically red flagged when a baby was due for an immunization that hadn’t been given, and guidance on how to address parental vaccine hesitancy. Thereafter, the on-time immunization rate began its sharp upward climb.

Session chair Karina Butler, MD, was clearly impressed.

“You make it sound so easy to get such an increment. What were the barriers and obstacles you ran into?” asked Dr. Butler of Temple Street Children’s University Hospital, Dublin.

 

 


“Certain providers in our group were a bit more hesitant about giving vaccines,” Dr. Stetson replied. “There had to be a lot of provider education to get them to use the resources we’d created. And parental vaccine hesitancy was a barrier for us. Of that 6% of infants who weren’t fully up to date at discharge, the majority of those were due to parental vaccine hesitancy. I think that’s still a barrier that’s going to need more work.”

Dr. Stetson reported having no relevant financial disclosures.

SOURCE: Stetson R. E-Poster Discussion Session 04.

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– The neonatal intensive care unit often represents a lost opportunity to bring an infant fully up to date for recommended age-appropriate immunizations– but it needn’t be that way, Raymond C. Stetson, MD, declared at the annual meeting of the European Society for Paediatric Infectious Diseases.

Dr. Raymond Stetson of the Mayo Clinic, Rochester, Minn.
Bruce Jancin/MDedge News
Dr. Raymond Stetson
He cited as a case in point the dramatic turnaround accomplished at the 26-bed NICU at the Mayo Clinic in Rochester, Minn., where he is a neonatal medicine fellow. When he and his coinvestigators conducted an electronic health record audit, they determined that only 56% of the 754 NICU patients cared for from 2015 through mid-2017 were fully up to date for the Advisory Committee on Immunization Practices-recommended vaccinations, excluding rotavirus vaccination, at the time of discharge or transfer. After developing and implementing an action plan, however, the on-time immunization rate jumped to 94% in the 155 patients discharged during the first 6 months of the new program.

“We were able to find that within our unit a small number of quality improvement measures enabled us to drastically increase our vaccination rate in this population. I think this shows that other units ought to be auditing their immunization rates, and if they find similar root causes of low rates our experience could be generalized to those units as well,” Dr. Stetson said.

It’s well established that premature infants are at increased risk for underimmunization. Dr. Stetson and his coinvestigators deemed the baseline 56% on-time immunization rate in their NICU patients to be unacceptable, because underimmunized infants are more vulnerable to vaccine-preventable illnesses after discharge. So using the quality improvement methodology known as DMAIC – for Define, Measure, Analyze, Improve, Control – the investigators surveyed Mayo NICU physicians and nurses and identified three root causes of the quality gap: lack of staff knowledge of the routine immunization schedule, lack of awareness of when a NICU patient’s vaccines were actually due, and parental vaccine hesitancy.

Newborn baby in incubator
copyright Metin Kiyak/Thinkstock
Newborn baby in incubator
Dr. Stetson and his coworkers then introduced three quality improvement measures: They provided easy Intranet access to the Advisory Committee on Immunization Practices (ACIP) routine immunization schedule, plus an Excel-based checklist that automatically red flagged when a baby was due for an immunization that hadn’t been given, and guidance on how to address parental vaccine hesitancy. Thereafter, the on-time immunization rate began its sharp upward climb.

Session chair Karina Butler, MD, was clearly impressed.

“You make it sound so easy to get such an increment. What were the barriers and obstacles you ran into?” asked Dr. Butler of Temple Street Children’s University Hospital, Dublin.

 

 


“Certain providers in our group were a bit more hesitant about giving vaccines,” Dr. Stetson replied. “There had to be a lot of provider education to get them to use the resources we’d created. And parental vaccine hesitancy was a barrier for us. Of that 6% of infants who weren’t fully up to date at discharge, the majority of those were due to parental vaccine hesitancy. I think that’s still a barrier that’s going to need more work.”

Dr. Stetson reported having no relevant financial disclosures.

SOURCE: Stetson R. E-Poster Discussion Session 04.

 

– The neonatal intensive care unit often represents a lost opportunity to bring an infant fully up to date for recommended age-appropriate immunizations– but it needn’t be that way, Raymond C. Stetson, MD, declared at the annual meeting of the European Society for Paediatric Infectious Diseases.

Dr. Raymond Stetson of the Mayo Clinic, Rochester, Minn.
Bruce Jancin/MDedge News
Dr. Raymond Stetson
He cited as a case in point the dramatic turnaround accomplished at the 26-bed NICU at the Mayo Clinic in Rochester, Minn., where he is a neonatal medicine fellow. When he and his coinvestigators conducted an electronic health record audit, they determined that only 56% of the 754 NICU patients cared for from 2015 through mid-2017 were fully up to date for the Advisory Committee on Immunization Practices-recommended vaccinations, excluding rotavirus vaccination, at the time of discharge or transfer. After developing and implementing an action plan, however, the on-time immunization rate jumped to 94% in the 155 patients discharged during the first 6 months of the new program.

“We were able to find that within our unit a small number of quality improvement measures enabled us to drastically increase our vaccination rate in this population. I think this shows that other units ought to be auditing their immunization rates, and if they find similar root causes of low rates our experience could be generalized to those units as well,” Dr. Stetson said.

It’s well established that premature infants are at increased risk for underimmunization. Dr. Stetson and his coinvestigators deemed the baseline 56% on-time immunization rate in their NICU patients to be unacceptable, because underimmunized infants are more vulnerable to vaccine-preventable illnesses after discharge. So using the quality improvement methodology known as DMAIC – for Define, Measure, Analyze, Improve, Control – the investigators surveyed Mayo NICU physicians and nurses and identified three root causes of the quality gap: lack of staff knowledge of the routine immunization schedule, lack of awareness of when a NICU patient’s vaccines were actually due, and parental vaccine hesitancy.

Newborn baby in incubator
copyright Metin Kiyak/Thinkstock
Newborn baby in incubator
Dr. Stetson and his coworkers then introduced three quality improvement measures: They provided easy Intranet access to the Advisory Committee on Immunization Practices (ACIP) routine immunization schedule, plus an Excel-based checklist that automatically red flagged when a baby was due for an immunization that hadn’t been given, and guidance on how to address parental vaccine hesitancy. Thereafter, the on-time immunization rate began its sharp upward climb.

Session chair Karina Butler, MD, was clearly impressed.

“You make it sound so easy to get such an increment. What were the barriers and obstacles you ran into?” asked Dr. Butler of Temple Street Children’s University Hospital, Dublin.

 

 


“Certain providers in our group were a bit more hesitant about giving vaccines,” Dr. Stetson replied. “There had to be a lot of provider education to get them to use the resources we’d created. And parental vaccine hesitancy was a barrier for us. Of that 6% of infants who weren’t fully up to date at discharge, the majority of those were due to parental vaccine hesitancy. I think that’s still a barrier that’s going to need more work.”

Dr. Stetson reported having no relevant financial disclosures.

SOURCE: Stetson R. E-Poster Discussion Session 04.

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Key clinical point: Using DMAIC quality improvement methodology allowed a NICU to improve on-time immunization rates at discharge dramatically in 6 months.

Major finding: Only 56% of 754 NICU patients from 2015 through mid-2017 were up to date for the ACIP-recommended vaccinations at discharge or transfer. After an intervention, the on-time immunization rate rose to 94% in 155 patients discharged during the first 6 months.

Study details: A study comparing 754 NICU patients prior to intervention and 155 after intervention.

Disclosures: Dr. Stetson reported having no relevant financial disclosures.

Source: Stetson R. E-Poster Discussion Session 04.

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Behavioral sleep intervention linked to sleep improvement in infants

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Fri, 01/18/2019 - 17:40

 

Infants show significant improvements in their sleep when their parents successfully carry out a behavioral sleep intervention (BSI) in a real-world setting, Sarah M. Honaker, PhD, of Indiana University, Indianapolis, and her associates, reported in the Journal of Pediatrics.

In a study of 652 parents who participated, parents started BSI when their infants were as young as less than 1 month of age and as late as 18 months of age. Most parents started BSI at 3-5 months.

A newborn sleeping in a crib.
NataliaDeriabina/Getty Images
Unmodified extinction was when a parent left the room and did not return to check on the infant. Modified extinction was when a parent left the room but returned periodically to check or reassure the infant. Parental presence was when a parent stayed in the room all the time but did not interact with the baby, and parental presence with support was when the parent stayed in the room all the time and patted or picked up the infant until the baby was asleep.

Crying generally was greatest the first night, occurring in 45% of cases when all BSI approaches were considered. It lasted a mean 43 minutes, which dropped significantly after 1 week to a mean 9 minutes (P less than .001). Crying was considered most intense (on a 1-5 scale) on the initial night of BSI, a mean 4.42, and this “was equally true for all of the BSI approaches,” Dr. Honaker and her colleagues wrote.

In most cases, the parents’ first attempt at BSI worked (83%). Success varied by BSI approach, with the highest first attempt success rate in the unmodified extinction group (90%), followed by parental presence without support (83%), modified extinction (81%), and parental presence with support (65%). Eventually, 27% of parents were successful with a different approach than the one with which they started. Most commonly, they changed from modified extinction to unmodified extinction (66% of those who changed approaches).

“The majority of parents report successfully implementing BSI at a variety of ages across infancy, primarily using extinction-based approaches,” the researchers concluded. “Few significant differences were found between approaches, suggesting that health providers should offer parents options for BSI implementation.”

SOURCE: Honaker SM et al., J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.04.009.

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Infants show significant improvements in their sleep when their parents successfully carry out a behavioral sleep intervention (BSI) in a real-world setting, Sarah M. Honaker, PhD, of Indiana University, Indianapolis, and her associates, reported in the Journal of Pediatrics.

In a study of 652 parents who participated, parents started BSI when their infants were as young as less than 1 month of age and as late as 18 months of age. Most parents started BSI at 3-5 months.

A newborn sleeping in a crib.
NataliaDeriabina/Getty Images
Unmodified extinction was when a parent left the room and did not return to check on the infant. Modified extinction was when a parent left the room but returned periodically to check or reassure the infant. Parental presence was when a parent stayed in the room all the time but did not interact with the baby, and parental presence with support was when the parent stayed in the room all the time and patted or picked up the infant until the baby was asleep.

Crying generally was greatest the first night, occurring in 45% of cases when all BSI approaches were considered. It lasted a mean 43 minutes, which dropped significantly after 1 week to a mean 9 minutes (P less than .001). Crying was considered most intense (on a 1-5 scale) on the initial night of BSI, a mean 4.42, and this “was equally true for all of the BSI approaches,” Dr. Honaker and her colleagues wrote.

In most cases, the parents’ first attempt at BSI worked (83%). Success varied by BSI approach, with the highest first attempt success rate in the unmodified extinction group (90%), followed by parental presence without support (83%), modified extinction (81%), and parental presence with support (65%). Eventually, 27% of parents were successful with a different approach than the one with which they started. Most commonly, they changed from modified extinction to unmodified extinction (66% of those who changed approaches).

“The majority of parents report successfully implementing BSI at a variety of ages across infancy, primarily using extinction-based approaches,” the researchers concluded. “Few significant differences were found between approaches, suggesting that health providers should offer parents options for BSI implementation.”

SOURCE: Honaker SM et al., J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.04.009.

 

Infants show significant improvements in their sleep when their parents successfully carry out a behavioral sleep intervention (BSI) in a real-world setting, Sarah M. Honaker, PhD, of Indiana University, Indianapolis, and her associates, reported in the Journal of Pediatrics.

In a study of 652 parents who participated, parents started BSI when their infants were as young as less than 1 month of age and as late as 18 months of age. Most parents started BSI at 3-5 months.

A newborn sleeping in a crib.
NataliaDeriabina/Getty Images
Unmodified extinction was when a parent left the room and did not return to check on the infant. Modified extinction was when a parent left the room but returned periodically to check or reassure the infant. Parental presence was when a parent stayed in the room all the time but did not interact with the baby, and parental presence with support was when the parent stayed in the room all the time and patted or picked up the infant until the baby was asleep.

Crying generally was greatest the first night, occurring in 45% of cases when all BSI approaches were considered. It lasted a mean 43 minutes, which dropped significantly after 1 week to a mean 9 minutes (P less than .001). Crying was considered most intense (on a 1-5 scale) on the initial night of BSI, a mean 4.42, and this “was equally true for all of the BSI approaches,” Dr. Honaker and her colleagues wrote.

In most cases, the parents’ first attempt at BSI worked (83%). Success varied by BSI approach, with the highest first attempt success rate in the unmodified extinction group (90%), followed by parental presence without support (83%), modified extinction (81%), and parental presence with support (65%). Eventually, 27% of parents were successful with a different approach than the one with which they started. Most commonly, they changed from modified extinction to unmodified extinction (66% of those who changed approaches).

“The majority of parents report successfully implementing BSI at a variety of ages across infancy, primarily using extinction-based approaches,” the researchers concluded. “Few significant differences were found between approaches, suggesting that health providers should offer parents options for BSI implementation.”

SOURCE: Honaker SM et al., J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.04.009.

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