PAS Annual Meeting 2014

VANCOUVER, B.C. – Recently, it’s become clear that milder forms of glycogen storage disease (GSD) – a genetic aberration in sugar metabolism – can cause problems with attention, mood, and growth that are easy to mistake for something else. GSD type 9 is a particularly potent imposter that occurs in boys and men only.

Once recognized, the solution is easy – cornstarch doses about every 4 hours. At the annual meeting of the Pediatric Academic Societies, a team lead by Dr. David A. Weinstein, a professor of pediatric endocrinology and the director of the glycogen storage disease program at the University of Florida, Gainesville, reported that a new, slow-release form of cornstarch called Glycosade lets patients skip their night dose so they can get a full 8 hours of sleep.

At the meeting, Dr. Weinstein told us how to recognize, diagnose, and treat glycogen storage disease, and a little bit about how effective intervention can change the lives of people who have it.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Recently, it’s become clear that milder forms of glycogen storage disease (GSD) – a genetic aberration in sugar metabolism – can cause problems with attention, mood, and growth that are easy to mistake for something else. GSD type 9 is a particularly potent imposter that occurs in boys and men only.

Once recognized, the solution is easy – cornstarch doses about every 4 hours. At the annual meeting of the Pediatric Academic Societies, a team lead by Dr. David A. Weinstein, a professor of pediatric endocrinology and the director of the glycogen storage disease program at the University of Florida, Gainesville, reported that a new, slow-release form of cornstarch called Glycosade lets patients skip their night dose so they can get a full 8 hours of sleep.

At the meeting, Dr. Weinstein told us how to recognize, diagnose, and treat glycogen storage disease, and a little bit about how effective intervention can change the lives of people who have it.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Recently, it’s become clear that milder forms of glycogen storage disease (GSD) – a genetic aberration in sugar metabolism – can cause problems with attention, mood, and growth that are easy to mistake for something else. GSD type 9 is a particularly potent imposter that occurs in boys and men only.

Once recognized, the solution is easy – cornstarch doses about every 4 hours. At the annual meeting of the Pediatric Academic Societies, a team lead by Dr. David A. Weinstein, a professor of pediatric endocrinology and the director of the glycogen storage disease program at the University of Florida, Gainesville, reported that a new, slow-release form of cornstarch called Glycosade lets patients skip their night dose so they can get a full 8 hours of sleep.

At the meeting, Dr. Weinstein told us how to recognize, diagnose, and treat glycogen storage disease, and a little bit about how effective intervention can change the lives of people who have it.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Dr. Daniel C. Payne has been investigating the Middle East Respiratory Syndrome coronavirus since the first case was reported in the Arabian Peninsula nearly 2 years ago.

An epidemiologist with the Centers for Disease Control and Prevention, Dr. Payne has traveled to the sites of outbreak and has worked with foreign officials to study and track down the virus.

Meanwhile, in the United States, CDC officials have been preparing for the potential arrival of the virus for the past year, Dr. Payne said. So when the first case was confirmed on May 2 in Munster, Ind., all the pieces were in place and health officials were ready.

How big a worry is MERS for U.S. physicians, what critical questions should they ask their patients, and what precautions should they take? Dr. Payne addressed some of these major concerns in a video interview during the annual meeting of the Pediatric Academic Societies and shared the silver lining to the virus’s arrival in the United States.

He also encouraged physicians to check the CDC website for the latest updates and practice protocols. Physicians can also visit the World Health Organization’s website for the latest global updates.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

VANCOUVER, B.C. – Dr. Daniel C. Payne has been investigating the Middle East Respiratory Syndrome coronavirus since the first case was reported in the Arabian Peninsula nearly 2 years ago.

An epidemiologist with the Centers for Disease Control and Prevention, Dr. Payne has traveled to the sites of outbreak and has worked with foreign officials to study and track down the virus.

Meanwhile, in the United States, CDC officials have been preparing for the potential arrival of the virus for the past year, Dr. Payne said. So when the first case was confirmed on May 2 in Munster, Ind., all the pieces were in place and health officials were ready.

How big a worry is MERS for U.S. physicians, what critical questions should they ask their patients, and what precautions should they take? Dr. Payne addressed some of these major concerns in a video interview during the annual meeting of the Pediatric Academic Societies and shared the silver lining to the virus’s arrival in the United States.

He also encouraged physicians to check the CDC website for the latest updates and practice protocols. Physicians can also visit the World Health Organization’s website for the latest global updates.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

VANCOUVER, B.C. – Dr. Daniel C. Payne has been investigating the Middle East Respiratory Syndrome coronavirus since the first case was reported in the Arabian Peninsula nearly 2 years ago.

An epidemiologist with the Centers for Disease Control and Prevention, Dr. Payne has traveled to the sites of outbreak and has worked with foreign officials to study and track down the virus.

Meanwhile, in the United States, CDC officials have been preparing for the potential arrival of the virus for the past year, Dr. Payne said. So when the first case was confirmed on May 2 in Munster, Ind., all the pieces were in place and health officials were ready.

How big a worry is MERS for U.S. physicians, what critical questions should they ask their patients, and what precautions should they take? Dr. Payne addressed some of these major concerns in a video interview during the annual meeting of the Pediatric Academic Societies and shared the silver lining to the virus’s arrival in the United States.

He also encouraged physicians to check the CDC website for the latest updates and practice protocols. Physicians can also visit the World Health Organization’s website for the latest global updates.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

Vancouver, B.C. – The antinausea and antiemetic agent ondansetron does not trigger malignant tachyarrhythmias in pediatric patients who have a healthy, native heart, suggests a retrospective cohort study presented at the annual meeting of the Pediatric Academic Societies.

Findings of the study, conducted at a large tertiary care children’s hospital and its affiliated clinics, and spanning a 6-year period, showed that the incidence of tachyarrhythmia within 24 hours after ondansetron (Zofran) administration was just 0.02%, or 1 in 6,299 patients.

Susan London/Frontline Medical News

All of the patients developing tachyarrhythmias had a preexisting cardiac diagnosis, including cardiac transplantation in some cases, and most also had other risk factors, reported lead researcher Dr. Breanne K.P. Shah, a fellow at the Medical College of Wisconsin and Children’s Hospital of Wisconsin in Madison.

The median dose of ondansetron administered was consistent with recommendations, although it ranged widely, she noted.

"Only children with cardiac diagnoses were found to have arrhythmia after ondansetron administration," Dr. Shah commented. "In subgroup analyses of patient populations who either received frequent doses or doses higher than average, such as patients in the ED or those with oncologic diagnoses, there were no documented tachyarrhythmias in the 24 hours after receiving ondansetron. It appears that these patients are at low risk."

"The findings of our study support consideration of cardiac monitoring for children with cardiac diagnoses who are receiving ondansetron. They do not support ECG screening or continuous monitoring of other pediatric populations receiving ondansetron," she concluded.

Session comoderator Dr. Julie Brown, an emergency medicine attending physician at Seattle Children’s Hospital who is with the department of pediatrics at the University of Washington, commented, "This is a really important study that I think probably illustrates the ‘creep’ of therapy from what is well studied into applications to a wider population, which is a little frightening."

"Sometimes, we come across something striking in our clinical work that prompts us to investigate a problem that could also maybe stack the deck with adverse events. So I’m wondering if you were aware of any of the identified cases before you proceeded with the retrospective study," she said.

"We were not," Dr. Shah replied, noting that the research was prompted by a 2011 Food and Drug Administration warning about potentially fatal abnormal heart rhythms in patients administered ondansetron.

In their warning about the drug, FDA "recommended avoiding use in patients with congenital long QT. Additionally, they recommended for ECG monitoring in patients with heart failure or bradyarrhythmias, patients taking other medications that can lead to QT prolongation, or patients with electrolyte abnormalities," Dr. Shah noted.

However, "to our knowledge, no pediatric studies have been done to evaluate adverse clinical outcomes with the use of ondansetron."

The researchers retrospectively studied 58,009 visits by patients aged 0-18 years in which ondansetron was administered. A total of 199,773 doses were given to 37,794 patients.

For single doses, the median dose was 4 mg (range, 0.11 to 36 mg) and the median dosage was 0.1 mg/kg per dose (range, 0.005 to 0.86 mg/kg per dose).

Overall, six patients developed a tachyarrhythmia within 24 hours of receiving ondansetron, for an incidence of 0.02%. They ranged in age from 9 weeks to 17 years, and two-thirds were male.

None died at the time of the event, according to Dr. Shah.

The average ondansetron dosage in these patients was 0.1 mg/kg per dose, and the time between dosing and onset of tachyarrhythmia ranged from 2 to 20 hours.

All six patients had underlying cardiac diagnoses (congenital conduction abnormality, congenital heart defect, cardiac tumor, or heart transplantation). And five had concomitant risk factors (use of medications known to prolong the QT interval, electrolyte abnormalities, or prolonged QTc interval).

"The retrospective nature of this study limits our ability to make conclusions," Dr. Shah acknowledged. "We used a conservative approach, assuming that any documentation of a tachyarrhythmia in the medical record within 24 hours of ondansetron constituted an ondansetron-related event, but we cannot prove cause."

Dr. Shah disclosed no relevant conflicts of interest.

Vancouver, B.C. – The antinausea and antiemetic agent ondansetron does not trigger malignant tachyarrhythmias in pediatric patients who have a healthy, native heart, suggests a retrospective cohort study presented at the annual meeting of the Pediatric Academic Societies.

Findings of the study, conducted at a large tertiary care children’s hospital and its affiliated clinics, and spanning a 6-year period, showed that the incidence of tachyarrhythmia within 24 hours after ondansetron (Zofran) administration was just 0.02%, or 1 in 6,299 patients.

Susan London/Frontline Medical News

All of the patients developing tachyarrhythmias had a preexisting cardiac diagnosis, including cardiac transplantation in some cases, and most also had other risk factors, reported lead researcher Dr. Breanne K.P. Shah, a fellow at the Medical College of Wisconsin and Children’s Hospital of Wisconsin in Madison.

The median dose of ondansetron administered was consistent with recommendations, although it ranged widely, she noted.

"Only children with cardiac diagnoses were found to have arrhythmia after ondansetron administration," Dr. Shah commented. "In subgroup analyses of patient populations who either received frequent doses or doses higher than average, such as patients in the ED or those with oncologic diagnoses, there were no documented tachyarrhythmias in the 24 hours after receiving ondansetron. It appears that these patients are at low risk."

"The findings of our study support consideration of cardiac monitoring for children with cardiac diagnoses who are receiving ondansetron. They do not support ECG screening or continuous monitoring of other pediatric populations receiving ondansetron," she concluded.

Session comoderator Dr. Julie Brown, an emergency medicine attending physician at Seattle Children’s Hospital who is with the department of pediatrics at the University of Washington, commented, "This is a really important study that I think probably illustrates the ‘creep’ of therapy from what is well studied into applications to a wider population, which is a little frightening."

"Sometimes, we come across something striking in our clinical work that prompts us to investigate a problem that could also maybe stack the deck with adverse events. So I’m wondering if you were aware of any of the identified cases before you proceeded with the retrospective study," she said.

"We were not," Dr. Shah replied, noting that the research was prompted by a 2011 Food and Drug Administration warning about potentially fatal abnormal heart rhythms in patients administered ondansetron.

In their warning about the drug, FDA "recommended avoiding use in patients with congenital long QT. Additionally, they recommended for ECG monitoring in patients with heart failure or bradyarrhythmias, patients taking other medications that can lead to QT prolongation, or patients with electrolyte abnormalities," Dr. Shah noted.

However, "to our knowledge, no pediatric studies have been done to evaluate adverse clinical outcomes with the use of ondansetron."

The researchers retrospectively studied 58,009 visits by patients aged 0-18 years in which ondansetron was administered. A total of 199,773 doses were given to 37,794 patients.

For single doses, the median dose was 4 mg (range, 0.11 to 36 mg) and the median dosage was 0.1 mg/kg per dose (range, 0.005 to 0.86 mg/kg per dose).

Overall, six patients developed a tachyarrhythmia within 24 hours of receiving ondansetron, for an incidence of 0.02%. They ranged in age from 9 weeks to 17 years, and two-thirds were male.

None died at the time of the event, according to Dr. Shah.

The average ondansetron dosage in these patients was 0.1 mg/kg per dose, and the time between dosing and onset of tachyarrhythmia ranged from 2 to 20 hours.

All six patients had underlying cardiac diagnoses (congenital conduction abnormality, congenital heart defect, cardiac tumor, or heart transplantation). And five had concomitant risk factors (use of medications known to prolong the QT interval, electrolyte abnormalities, or prolonged QTc interval).

"The retrospective nature of this study limits our ability to make conclusions," Dr. Shah acknowledged. "We used a conservative approach, assuming that any documentation of a tachyarrhythmia in the medical record within 24 hours of ondansetron constituted an ondansetron-related event, but we cannot prove cause."

Dr. Shah disclosed no relevant conflicts of interest.

Vancouver, B.C. – The antinausea and antiemetic agent ondansetron does not trigger malignant tachyarrhythmias in pediatric patients who have a healthy, native heart, suggests a retrospective cohort study presented at the annual meeting of the Pediatric Academic Societies.

Findings of the study, conducted at a large tertiary care children’s hospital and its affiliated clinics, and spanning a 6-year period, showed that the incidence of tachyarrhythmia within 24 hours after ondansetron (Zofran) administration was just 0.02%, or 1 in 6,299 patients.

Susan London/Frontline Medical News

All of the patients developing tachyarrhythmias had a preexisting cardiac diagnosis, including cardiac transplantation in some cases, and most also had other risk factors, reported lead researcher Dr. Breanne K.P. Shah, a fellow at the Medical College of Wisconsin and Children’s Hospital of Wisconsin in Madison.

The median dose of ondansetron administered was consistent with recommendations, although it ranged widely, she noted.

"Only children with cardiac diagnoses were found to have arrhythmia after ondansetron administration," Dr. Shah commented. "In subgroup analyses of patient populations who either received frequent doses or doses higher than average, such as patients in the ED or those with oncologic diagnoses, there were no documented tachyarrhythmias in the 24 hours after receiving ondansetron. It appears that these patients are at low risk."

"The findings of our study support consideration of cardiac monitoring for children with cardiac diagnoses who are receiving ondansetron. They do not support ECG screening or continuous monitoring of other pediatric populations receiving ondansetron," she concluded.

Session comoderator Dr. Julie Brown, an emergency medicine attending physician at Seattle Children’s Hospital who is with the department of pediatrics at the University of Washington, commented, "This is a really important study that I think probably illustrates the ‘creep’ of therapy from what is well studied into applications to a wider population, which is a little frightening."

"Sometimes, we come across something striking in our clinical work that prompts us to investigate a problem that could also maybe stack the deck with adverse events. So I’m wondering if you were aware of any of the identified cases before you proceeded with the retrospective study," she said.

"We were not," Dr. Shah replied, noting that the research was prompted by a 2011 Food and Drug Administration warning about potentially fatal abnormal heart rhythms in patients administered ondansetron.

In their warning about the drug, FDA "recommended avoiding use in patients with congenital long QT. Additionally, they recommended for ECG monitoring in patients with heart failure or bradyarrhythmias, patients taking other medications that can lead to QT prolongation, or patients with electrolyte abnormalities," Dr. Shah noted.

However, "to our knowledge, no pediatric studies have been done to evaluate adverse clinical outcomes with the use of ondansetron."

The researchers retrospectively studied 58,009 visits by patients aged 0-18 years in which ondansetron was administered. A total of 199,773 doses were given to 37,794 patients.

For single doses, the median dose was 4 mg (range, 0.11 to 36 mg) and the median dosage was 0.1 mg/kg per dose (range, 0.005 to 0.86 mg/kg per dose).

Overall, six patients developed a tachyarrhythmia within 24 hours of receiving ondansetron, for an incidence of 0.02%. They ranged in age from 9 weeks to 17 years, and two-thirds were male.

None died at the time of the event, according to Dr. Shah.

The average ondansetron dosage in these patients was 0.1 mg/kg per dose, and the time between dosing and onset of tachyarrhythmia ranged from 2 to 20 hours.

All six patients had underlying cardiac diagnoses (congenital conduction abnormality, congenital heart defect, cardiac tumor, or heart transplantation). And five had concomitant risk factors (use of medications known to prolong the QT interval, electrolyte abnormalities, or prolonged QTc interval).

"The retrospective nature of this study limits our ability to make conclusions," Dr. Shah acknowledged. "We used a conservative approach, assuming that any documentation of a tachyarrhythmia in the medical record within 24 hours of ondansetron constituted an ondansetron-related event, but we cannot prove cause."

Dr. Shah disclosed no relevant conflicts of interest.

VANCOUVER, B.C. – A targeted cytomegalovirus screening approach that tests only newborns who do not pass their hearing test would identify the majority of those who have CMV-related sensorineural hearing loss at birth, according to data from the CMV and Hearing Multicenter Screening Study.

All of 99,778 newborns born during 2007-2012 in seven states studied had both auditory testing and virologic testing of saliva for CMV infection shortly after birth.

Overall, 461 (0.5%) tested positive for CMV infection, lead investigator Karen B. Fowler, Dr.P.H., a professor at the University of Alabama, Birmingham, reported at the annual meeting of the Pediatric Academic Societies.

The proportion of newborns who did not pass their hearing test and were therefore referred for further evaluation was higher in the CMV-positive group than in the CMV-negative group (7.1% vs. 0.9%; P less than .0001). Findings were similar whether the newborn was in the well-baby nursery or in the neonatal intensive care unit.

Hearing screening identified 21 (60%) of the 35 newborns with CMV-related sensorineural hearing loss. However, this amounted to only 4.5% of all CMV-positive infants in the cohort.

"Our study found that infants who are CMV positive will refer or not pass their newborn hearing screening at a significantly higher rate than infants without CMV infection, suggesting that newborns who refer on their hearing screen and have no other known etiology for their possible hearing loss should be screened for CMV infection," Dr. Fowler said in an interview.

This targeted approach "does not identify all infants with congenital CMV infection or all CMV-related hearing loss. However, our study found that 60% of the CMV-related hearing loss that occurs in the newborn period was identified using this approach," she added.

As for clinical implications, "infants who are CMV positive with sensorineural hearing loss will need continued monitoring of their hearing loss for further deterioration, as well as possible antiviral treatment. Those infants who are CMV positive, even if further evaluation indicates that hearing loss is not present, will need continued monitoring for possible late-onset hearing loss. Although appropriate early intervention should occur for any infant with hearing loss, monitoring for late-onset and progressive hearing losses might not occur for CMV-positive infants if the etiology of the hearing loss was unknown," noted Dr. Fowler.

The investigators plan "to continue to explore possible mechanisms of CMV-related hearing loss and whether there are predictors or indicators of which children with CMV infection will go on to have hearing loss or further deterioration of their hearing loss. Currently, no such indicators exist," she concluded.

Dr. Fowler disclosed no relevant conflicts of interest.

VANCOUVER, B.C. – A targeted cytomegalovirus screening approach that tests only newborns who do not pass their hearing test would identify the majority of those who have CMV-related sensorineural hearing loss at birth, according to data from the CMV and Hearing Multicenter Screening Study.

All of 99,778 newborns born during 2007-2012 in seven states studied had both auditory testing and virologic testing of saliva for CMV infection shortly after birth.

Overall, 461 (0.5%) tested positive for CMV infection, lead investigator Karen B. Fowler, Dr.P.H., a professor at the University of Alabama, Birmingham, reported at the annual meeting of the Pediatric Academic Societies.

The proportion of newborns who did not pass their hearing test and were therefore referred for further evaluation was higher in the CMV-positive group than in the CMV-negative group (7.1% vs. 0.9%; P less than .0001). Findings were similar whether the newborn was in the well-baby nursery or in the neonatal intensive care unit.

Hearing screening identified 21 (60%) of the 35 newborns with CMV-related sensorineural hearing loss. However, this amounted to only 4.5% of all CMV-positive infants in the cohort.

"Our study found that infants who are CMV positive will refer or not pass their newborn hearing screening at a significantly higher rate than infants without CMV infection, suggesting that newborns who refer on their hearing screen and have no other known etiology for their possible hearing loss should be screened for CMV infection," Dr. Fowler said in an interview.

This targeted approach "does not identify all infants with congenital CMV infection or all CMV-related hearing loss. However, our study found that 60% of the CMV-related hearing loss that occurs in the newborn period was identified using this approach," she added.

As for clinical implications, "infants who are CMV positive with sensorineural hearing loss will need continued monitoring of their hearing loss for further deterioration, as well as possible antiviral treatment. Those infants who are CMV positive, even if further evaluation indicates that hearing loss is not present, will need continued monitoring for possible late-onset hearing loss. Although appropriate early intervention should occur for any infant with hearing loss, monitoring for late-onset and progressive hearing losses might not occur for CMV-positive infants if the etiology of the hearing loss was unknown," noted Dr. Fowler.

The investigators plan "to continue to explore possible mechanisms of CMV-related hearing loss and whether there are predictors or indicators of which children with CMV infection will go on to have hearing loss or further deterioration of their hearing loss. Currently, no such indicators exist," she concluded.

Dr. Fowler disclosed no relevant conflicts of interest.

VANCOUVER, B.C. – A targeted cytomegalovirus screening approach that tests only newborns who do not pass their hearing test would identify the majority of those who have CMV-related sensorineural hearing loss at birth, according to data from the CMV and Hearing Multicenter Screening Study.

All of 99,778 newborns born during 2007-2012 in seven states studied had both auditory testing and virologic testing of saliva for CMV infection shortly after birth.

Overall, 461 (0.5%) tested positive for CMV infection, lead investigator Karen B. Fowler, Dr.P.H., a professor at the University of Alabama, Birmingham, reported at the annual meeting of the Pediatric Academic Societies.

The proportion of newborns who did not pass their hearing test and were therefore referred for further evaluation was higher in the CMV-positive group than in the CMV-negative group (7.1% vs. 0.9%; P less than .0001). Findings were similar whether the newborn was in the well-baby nursery or in the neonatal intensive care unit.

Hearing screening identified 21 (60%) of the 35 newborns with CMV-related sensorineural hearing loss. However, this amounted to only 4.5% of all CMV-positive infants in the cohort.

"Our study found that infants who are CMV positive will refer or not pass their newborn hearing screening at a significantly higher rate than infants without CMV infection, suggesting that newborns who refer on their hearing screen and have no other known etiology for their possible hearing loss should be screened for CMV infection," Dr. Fowler said in an interview.

This targeted approach "does not identify all infants with congenital CMV infection or all CMV-related hearing loss. However, our study found that 60% of the CMV-related hearing loss that occurs in the newborn period was identified using this approach," she added.

As for clinical implications, "infants who are CMV positive with sensorineural hearing loss will need continued monitoring of their hearing loss for further deterioration, as well as possible antiviral treatment. Those infants who are CMV positive, even if further evaluation indicates that hearing loss is not present, will need continued monitoring for possible late-onset hearing loss. Although appropriate early intervention should occur for any infant with hearing loss, monitoring for late-onset and progressive hearing losses might not occur for CMV-positive infants if the etiology of the hearing loss was unknown," noted Dr. Fowler.

The investigators plan "to continue to explore possible mechanisms of CMV-related hearing loss and whether there are predictors or indicators of which children with CMV infection will go on to have hearing loss or further deterioration of their hearing loss. Currently, no such indicators exist," she concluded.

Dr. Fowler disclosed no relevant conflicts of interest.

VANCOUVER, B.C. – If it’s an option, subcutaneous methotrexate is the way to go for new-onset juvenile idiopathic arthritis, based on a study of 47 patients at Children’s Mercy Hospital in Kansas City, Mo.

In the study, 21 children received subcutaneous methotrexate and 26 received oral methotrexate (MTX). The children, regardless of administration route, were on the same, standard dose of MTX, 15 mg/m² weekly, plus 1 mg/day of folic acid.

At 3 months, 13 (28%) of the 47 children reached an ACR [American College of Rheumatology] pediatric 70. The measure is defined as a 70% improvement in joint counts, global assessments, and other measures from baseline. Nine (69%) of the 13 had been on subcutaneous methotrexate and 4 (31%) had been on the oral formulation.

Additionally, red blood cell concentrations of long-chain MTX polyglutamate, a marker of better response, were higher in the children given subcutaneous methotrexate (82 nmol/L vs. 36 nmol/L) The differences were statistically significant.

"I was a little bit shocked" by the results, said lead investigator Dr. Mara Becker, director of the rheumatology division at Children’s Mercy who is with the department of pediatrics at the University of Missouri–Kansas City. "I’ve been in the camp of saying ‘orally or subcutaneously, however you want to give it.’ This solidified the fact that I’d give SQ first, especially if I want to prevent having to use a biologic."

Although "we are still debating the best way to give methotrexate when it’s started, kids on subcutaneous methotrexate got better faster." That’s likely because of the better bioavailability – and fewer GI side effects – when methotrexate bypasses the gut, she said at the annual meeting of the Pediatric Academic Societies.

Needle phobia, however, is the kicker. "Kids get anxious about having to get a shot each week; that’s why people shy away from it. A lot of times, we start orally and switch to SQ if kids get side effects, but if they have needle phobia, you’re in a difficult place," she said.

The children were, on average, about 10 years old, and the majority of them were girls. There were no significant between-group clinical differences at baseline.

NSAIDS, low-dose prednisone, and steroid joint shots were allowed as needed. At 3 months, NSAID and oral steroid use was statistically the same between the groups, but SQ methotrexate patients were significantly more likely to have gotten joint injections when started on methotrexate. To account for the difference, injected joints were counted as "active joints" in the analysis.

The recent shortage of subcutaneous methotrexate, often the first choice among U.S. physicians, led to the study. About half of the children had to be "on oral because of the shortage, so we said, ‘alright, let’s take a look and see how they do’," Dr. Becker said.

Dr. Becker has no relevant disclosures. The ACR Research Foundation helped fund the work.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – If it’s an option, subcutaneous methotrexate is the way to go for new-onset juvenile idiopathic arthritis, based on a study of 47 patients at Children’s Mercy Hospital in Kansas City, Mo.

In the study, 21 children received subcutaneous methotrexate and 26 received oral methotrexate (MTX). The children, regardless of administration route, were on the same, standard dose of MTX, 15 mg/m² weekly, plus 1 mg/day of folic acid.

At 3 months, 13 (28%) of the 47 children reached an ACR [American College of Rheumatology] pediatric 70. The measure is defined as a 70% improvement in joint counts, global assessments, and other measures from baseline. Nine (69%) of the 13 had been on subcutaneous methotrexate and 4 (31%) had been on the oral formulation.

Additionally, red blood cell concentrations of long-chain MTX polyglutamate, a marker of better response, were higher in the children given subcutaneous methotrexate (82 nmol/L vs. 36 nmol/L) The differences were statistically significant.

"I was a little bit shocked" by the results, said lead investigator Dr. Mara Becker, director of the rheumatology division at Children’s Mercy who is with the department of pediatrics at the University of Missouri–Kansas City. "I’ve been in the camp of saying ‘orally or subcutaneously, however you want to give it.’ This solidified the fact that I’d give SQ first, especially if I want to prevent having to use a biologic."

Although "we are still debating the best way to give methotrexate when it’s started, kids on subcutaneous methotrexate got better faster." That’s likely because of the better bioavailability – and fewer GI side effects – when methotrexate bypasses the gut, she said at the annual meeting of the Pediatric Academic Societies.

Needle phobia, however, is the kicker. "Kids get anxious about having to get a shot each week; that’s why people shy away from it. A lot of times, we start orally and switch to SQ if kids get side effects, but if they have needle phobia, you’re in a difficult place," she said.

The children were, on average, about 10 years old, and the majority of them were girls. There were no significant between-group clinical differences at baseline.

NSAIDS, low-dose prednisone, and steroid joint shots were allowed as needed. At 3 months, NSAID and oral steroid use was statistically the same between the groups, but SQ methotrexate patients were significantly more likely to have gotten joint injections when started on methotrexate. To account for the difference, injected joints were counted as "active joints" in the analysis.

The recent shortage of subcutaneous methotrexate, often the first choice among U.S. physicians, led to the study. About half of the children had to be "on oral because of the shortage, so we said, ‘alright, let’s take a look and see how they do’," Dr. Becker said.

Dr. Becker has no relevant disclosures. The ACR Research Foundation helped fund the work.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – If it’s an option, subcutaneous methotrexate is the way to go for new-onset juvenile idiopathic arthritis, based on a study of 47 patients at Children’s Mercy Hospital in Kansas City, Mo.

In the study, 21 children received subcutaneous methotrexate and 26 received oral methotrexate (MTX). The children, regardless of administration route, were on the same, standard dose of MTX, 15 mg/m² weekly, plus 1 mg/day of folic acid.

At 3 months, 13 (28%) of the 47 children reached an ACR [American College of Rheumatology] pediatric 70. The measure is defined as a 70% improvement in joint counts, global assessments, and other measures from baseline. Nine (69%) of the 13 had been on subcutaneous methotrexate and 4 (31%) had been on the oral formulation.

Additionally, red blood cell concentrations of long-chain MTX polyglutamate, a marker of better response, were higher in the children given subcutaneous methotrexate (82 nmol/L vs. 36 nmol/L) The differences were statistically significant.

"I was a little bit shocked" by the results, said lead investigator Dr. Mara Becker, director of the rheumatology division at Children’s Mercy who is with the department of pediatrics at the University of Missouri–Kansas City. "I’ve been in the camp of saying ‘orally or subcutaneously, however you want to give it.’ This solidified the fact that I’d give SQ first, especially if I want to prevent having to use a biologic."

Although "we are still debating the best way to give methotrexate when it’s started, kids on subcutaneous methotrexate got better faster." That’s likely because of the better bioavailability – and fewer GI side effects – when methotrexate bypasses the gut, she said at the annual meeting of the Pediatric Academic Societies.

Needle phobia, however, is the kicker. "Kids get anxious about having to get a shot each week; that’s why people shy away from it. A lot of times, we start orally and switch to SQ if kids get side effects, but if they have needle phobia, you’re in a difficult place," she said.

The children were, on average, about 10 years old, and the majority of them were girls. There were no significant between-group clinical differences at baseline.

NSAIDS, low-dose prednisone, and steroid joint shots were allowed as needed. At 3 months, NSAID and oral steroid use was statistically the same between the groups, but SQ methotrexate patients were significantly more likely to have gotten joint injections when started on methotrexate. To account for the difference, injected joints were counted as "active joints" in the analysis.

The recent shortage of subcutaneous methotrexate, often the first choice among U.S. physicians, led to the study. About half of the children had to be "on oral because of the shortage, so we said, ‘alright, let’s take a look and see how they do’," Dr. Becker said.

Dr. Becker has no relevant disclosures. The ACR Research Foundation helped fund the work.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Text message reminders are an effective strategy for increasing receipt and timeliness of influenza vaccination in children, and they work even better when they contain brief educational information, a randomized trial showed.

Historically, only about half of children needing a second dose actually get it, according to first author Dr. Melissa Stockwell of the department of pediatrics at Columbia University Medical Center, New York.

The average time at which that dose is received is twice the recommended 28 days. "So we clearly have a problem," she said at the annual meeting of the Pediatric Academic Societies.

Common reasons for failing to return for the second vaccine doses include forgetting to do so, and lack of knowledge that a second dose is needed or why.

The trial, called Flu2Text, was conducted among 660 low-income, urban children aged 6 months to 8 years who received the first of two doses of flu vaccine at community clinics affiliated with an academic medical center and whose parents had a cell phone that could receive text messages. In the groups randomized to messages, the messages were sent three times before the second dose was due, once on the due date, and once 2 weeks thereafter.

The results showed that the rate of receipt of the second dose of vaccine was 57% among children whose parents were given only usual care, consisting of a written reminder of the due date for the second dose. But it was 67% in a group sent conventional text messages, which reminded them to bring their child on the due date and gave clinic walk-in hours, and 73% in a group sent educational text messages, which included the same reminder, brief information, and the option to ask for more information about why timing was important, why two doses are needed, and the nature of adverse effects (P = .003).

The rate of timely receipt (defined in the trial as receipt of the second dose within 42 days of the first dose) was 27% with usual care, compared with 34% with conventional text messages and 44% with educational text messages (P = .001).

"Among young, low-income urban children, the addition of text message reminders was associated with increased receipt and timeliness of a second dose of flu vaccine," Dr. Stockwell said. "Embedding educational information did seem to impact its effectiveness, particularly in getting vaccines in a more timely fashion."

A session attendee wondered, "Did you ask in the postsurvey why some parents did not get the second dose despite the reminders?"

"Yes," Dr. Stockwell replied. "Some of it was a reaction. A lot of our population is convinced that the flu shot causes the flu. So some said, ‘My kid was really sick after the first dose, so I decided not to come back.’ That was the most common."

Another attendee commented, "The dose response is really quite striking. But even with the conventional texting, it looks like it is a little more effective than in past studies. ...The whole thing just seems to be a little better. What’s going on?"

"I think it’s because our previous studies looked at first dose, and this was looking at second dose. So these are families who have gotten past the sort of vaccine hesitancy and misperceptions about the flu vaccine – not everybody, but most of them. So you sort of take that whole part out, so now you are just sort of dealing more with not knowing they need a second dose or the effectiveness. That’s my guess as to why."

In additional study findings, none of the text messages was undeliverable, and only 0.5% of parents randomized to text messages opted to stop receiving them. In the educational text message group, 16% of parents responded to the interactive messages to get more information.

Overall, 98% of parents in the text message groups were very satisfied. The aspects they most commonly liked were the inclusion of a reminder, the provision of information, the quick nature of texting, and the perception that the messages demonstrated that the clinic cared about them.

Also, the majority credited the text message with having an impact on their child getting the second dose of vaccine (61%) and getting it sooner than they would have without the reminder (70%).

Study limitations included the inability to enroll 12% of otherwise eligible children whose families did not have a cell phone and the potential lack of generalizability to other settings, said Dr. Stockwell.

He disclosed an affiliation with the Pfizer Medical Education Group.

VANCOUVER, B.C. – Text message reminders are an effective strategy for increasing receipt and timeliness of influenza vaccination in children, and they work even better when they contain brief educational information, a randomized trial showed.

Historically, only about half of children needing a second dose actually get it, according to first author Dr. Melissa Stockwell of the department of pediatrics at Columbia University Medical Center, New York.

The average time at which that dose is received is twice the recommended 28 days. "So we clearly have a problem," she said at the annual meeting of the Pediatric Academic Societies.

Common reasons for failing to return for the second vaccine doses include forgetting to do so, and lack of knowledge that a second dose is needed or why.

The trial, called Flu2Text, was conducted among 660 low-income, urban children aged 6 months to 8 years who received the first of two doses of flu vaccine at community clinics affiliated with an academic medical center and whose parents had a cell phone that could receive text messages. In the groups randomized to messages, the messages were sent three times before the second dose was due, once on the due date, and once 2 weeks thereafter.

The results showed that the rate of receipt of the second dose of vaccine was 57% among children whose parents were given only usual care, consisting of a written reminder of the due date for the second dose. But it was 67% in a group sent conventional text messages, which reminded them to bring their child on the due date and gave clinic walk-in hours, and 73% in a group sent educational text messages, which included the same reminder, brief information, and the option to ask for more information about why timing was important, why two doses are needed, and the nature of adverse effects (P = .003).

The rate of timely receipt (defined in the trial as receipt of the second dose within 42 days of the first dose) was 27% with usual care, compared with 34% with conventional text messages and 44% with educational text messages (P = .001).

"Among young, low-income urban children, the addition of text message reminders was associated with increased receipt and timeliness of a second dose of flu vaccine," Dr. Stockwell said. "Embedding educational information did seem to impact its effectiveness, particularly in getting vaccines in a more timely fashion."

A session attendee wondered, "Did you ask in the postsurvey why some parents did not get the second dose despite the reminders?"

"Yes," Dr. Stockwell replied. "Some of it was a reaction. A lot of our population is convinced that the flu shot causes the flu. So some said, ‘My kid was really sick after the first dose, so I decided not to come back.’ That was the most common."

Another attendee commented, "The dose response is really quite striking. But even with the conventional texting, it looks like it is a little more effective than in past studies. ...The whole thing just seems to be a little better. What’s going on?"

"I think it’s because our previous studies looked at first dose, and this was looking at second dose. So these are families who have gotten past the sort of vaccine hesitancy and misperceptions about the flu vaccine – not everybody, but most of them. So you sort of take that whole part out, so now you are just sort of dealing more with not knowing they need a second dose or the effectiveness. That’s my guess as to why."

In additional study findings, none of the text messages was undeliverable, and only 0.5% of parents randomized to text messages opted to stop receiving them. In the educational text message group, 16% of parents responded to the interactive messages to get more information.

Overall, 98% of parents in the text message groups were very satisfied. The aspects they most commonly liked were the inclusion of a reminder, the provision of information, the quick nature of texting, and the perception that the messages demonstrated that the clinic cared about them.

Also, the majority credited the text message with having an impact on their child getting the second dose of vaccine (61%) and getting it sooner than they would have without the reminder (70%).

Study limitations included the inability to enroll 12% of otherwise eligible children whose families did not have a cell phone and the potential lack of generalizability to other settings, said Dr. Stockwell.

He disclosed an affiliation with the Pfizer Medical Education Group.

VANCOUVER, B.C. – Text message reminders are an effective strategy for increasing receipt and timeliness of influenza vaccination in children, and they work even better when they contain brief educational information, a randomized trial showed.

Historically, only about half of children needing a second dose actually get it, according to first author Dr. Melissa Stockwell of the department of pediatrics at Columbia University Medical Center, New York.

The average time at which that dose is received is twice the recommended 28 days. "So we clearly have a problem," she said at the annual meeting of the Pediatric Academic Societies.

Common reasons for failing to return for the second vaccine doses include forgetting to do so, and lack of knowledge that a second dose is needed or why.

The trial, called Flu2Text, was conducted among 660 low-income, urban children aged 6 months to 8 years who received the first of two doses of flu vaccine at community clinics affiliated with an academic medical center and whose parents had a cell phone that could receive text messages. In the groups randomized to messages, the messages were sent three times before the second dose was due, once on the due date, and once 2 weeks thereafter.

The results showed that the rate of receipt of the second dose of vaccine was 57% among children whose parents were given only usual care, consisting of a written reminder of the due date for the second dose. But it was 67% in a group sent conventional text messages, which reminded them to bring their child on the due date and gave clinic walk-in hours, and 73% in a group sent educational text messages, which included the same reminder, brief information, and the option to ask for more information about why timing was important, why two doses are needed, and the nature of adverse effects (P = .003).

The rate of timely receipt (defined in the trial as receipt of the second dose within 42 days of the first dose) was 27% with usual care, compared with 34% with conventional text messages and 44% with educational text messages (P = .001).

"Among young, low-income urban children, the addition of text message reminders was associated with increased receipt and timeliness of a second dose of flu vaccine," Dr. Stockwell said. "Embedding educational information did seem to impact its effectiveness, particularly in getting vaccines in a more timely fashion."

A session attendee wondered, "Did you ask in the postsurvey why some parents did not get the second dose despite the reminders?"

"Yes," Dr. Stockwell replied. "Some of it was a reaction. A lot of our population is convinced that the flu shot causes the flu. So some said, ‘My kid was really sick after the first dose, so I decided not to come back.’ That was the most common."

Another attendee commented, "The dose response is really quite striking. But even with the conventional texting, it looks like it is a little more effective than in past studies. ...The whole thing just seems to be a little better. What’s going on?"

"I think it’s because our previous studies looked at first dose, and this was looking at second dose. So these are families who have gotten past the sort of vaccine hesitancy and misperceptions about the flu vaccine – not everybody, but most of them. So you sort of take that whole part out, so now you are just sort of dealing more with not knowing they need a second dose or the effectiveness. That’s my guess as to why."

In additional study findings, none of the text messages was undeliverable, and only 0.5% of parents randomized to text messages opted to stop receiving them. In the educational text message group, 16% of parents responded to the interactive messages to get more information.

Overall, 98% of parents in the text message groups were very satisfied. The aspects they most commonly liked were the inclusion of a reminder, the provision of information, the quick nature of texting, and the perception that the messages demonstrated that the clinic cared about them.

Also, the majority credited the text message with having an impact on their child getting the second dose of vaccine (61%) and getting it sooner than they would have without the reminder (70%).

Study limitations included the inability to enroll 12% of otherwise eligible children whose families did not have a cell phone and the potential lack of generalizability to other settings, said Dr. Stockwell.

He disclosed an affiliation with the Pfizer Medical Education Group.

VANCOUVER, B.C. – Physician response to parents who refuse to allow their child to be vaccinated is changing, and vaccine refusal is a growing problem, according to an analysis of national survey data.

More often, pediatricians are responding by dismissing these parents and children from their practice.

Researchers led by Dr. Catherine Hough-Telford of the department of pediatrics at the University of Alabama at Birmingham analyzed data from the 2006 and 2013 American Academy of Pediatrics periodic surveys. Analyses were based on 629 and 627 respondents, respectively.

The proportion of pediatricians encountering parents who refused vaccines for their children in the past year rose significantly, from 75% in 2006 to 87% in 2013, a 16% increase she reported at the annual meeting of the Pediatric Academic Societies.

There were decreases in the proportion of refusals in which the stated reason was the child being too small (from 23% to 15%), discomfort (from 42% to 17%), and autism or thimerosal (from 74% to 65%). Meanwhile, there was an increase in the proportion of parents who believed the vaccine was unnecessary (from 63% to 73%).

Nationally, in 2013, the leading reasons parents refused vaccines were believing they were unnecessary and safety concerns, whereas the leading reasons they requested a delay in vaccines were discomfort and concern that a child was getting too many vaccines at one time.

When faced with parental refusal, pediatricians increasingly reported dismissing the parent and patient from their practice: 6% did so in 2006, while 12% did so in 2013 – a 100% increase. In 2013, they had dismissed an average of about three patients for this reason in the past year, at a mean age of about 11 months.

"Vaccine hesitancy is increasing over time. The perception that immunizations are unnecessary has also increased, and the concern for autism or thimerosal has actually declined," commented Dr. Hough-Telford. "Pediatrician response to vaccine hesitancy has also been changing over time, and the rate of dismissal has doubled in the last 7 years."

Educational efforts have had a limited impact in this setting, she noted. "In fact, there was a study that came out this past March showing that provaccine messages may not or do not increase the intent to immunize, and providing correct educational vaccine information actually decreases both vaccine misperceptions but, counterintuitively, also decreases intent to immunize," she noted (Pediatrics 2014;133:e835-e42).

Session attendee Dr. Kelly Ochoa of Children’s Hospital Los Angeles asked, "Given the evidence from several recent studies showing that educating families about vaccine-preventable illnesses isn’t improving their willingness to get them, what do we do now?"

In the study on provaccine messages, the messages were ineffective mainly among parents whose beliefs were already fixed, Dr. Hough-Telford noted. "We still should do it, but perhaps find out what the parents’ beliefs are before [getting started]."

Session comoderator Dr. Heather Brumberg, a neonatologist in the department of pediatrics at New York Medical College, commented, "Do you think that some education is working, because there is less concern about autism?"

"I do," Dr. Hough-Telford replied. "Between 2006 and 2013, there has been a lot of effort on behalf of pediatricians, the CDC [Centers for Disease Control and Prevention], and the AAP to minimize the concerns about autism ... and to really debunk those myths. So I think that’s why we are seeing this downtick in autism and thimerosal concerns, but it’s very interesting that parents are thinking that immunizations are actually unnecessary. So it’s like they swapped [myths]."

"Have you changed your practice because of the results of the study?" Dr. Brumberg asked.

"Yes, I have, in how I approach parents who are refusing vaccines," said Dr. Hough-Telford, adding that she tries to find out parents’ beliefs before she starts her education efforts, explains to parents why vaccines really are necessary, and alerts them to vaccine-preventable diseases that are occurring in the country.

Dr. Hough-Telford disclosed no relevant conflicts of interest.

VANCOUVER, B.C. – Physician response to parents who refuse to allow their child to be vaccinated is changing, and vaccine refusal is a growing problem, according to an analysis of national survey data.

More often, pediatricians are responding by dismissing these parents and children from their practice.

Researchers led by Dr. Catherine Hough-Telford of the department of pediatrics at the University of Alabama at Birmingham analyzed data from the 2006 and 2013 American Academy of Pediatrics periodic surveys. Analyses were based on 629 and 627 respondents, respectively.

The proportion of pediatricians encountering parents who refused vaccines for their children in the past year rose significantly, from 75% in 2006 to 87% in 2013, a 16% increase she reported at the annual meeting of the Pediatric Academic Societies.

There were decreases in the proportion of refusals in which the stated reason was the child being too small (from 23% to 15%), discomfort (from 42% to 17%), and autism or thimerosal (from 74% to 65%). Meanwhile, there was an increase in the proportion of parents who believed the vaccine was unnecessary (from 63% to 73%).

Nationally, in 2013, the leading reasons parents refused vaccines were believing they were unnecessary and safety concerns, whereas the leading reasons they requested a delay in vaccines were discomfort and concern that a child was getting too many vaccines at one time.

When faced with parental refusal, pediatricians increasingly reported dismissing the parent and patient from their practice: 6% did so in 2006, while 12% did so in 2013 – a 100% increase. In 2013, they had dismissed an average of about three patients for this reason in the past year, at a mean age of about 11 months.

"Vaccine hesitancy is increasing over time. The perception that immunizations are unnecessary has also increased, and the concern for autism or thimerosal has actually declined," commented Dr. Hough-Telford. "Pediatrician response to vaccine hesitancy has also been changing over time, and the rate of dismissal has doubled in the last 7 years."

Educational efforts have had a limited impact in this setting, she noted. "In fact, there was a study that came out this past March showing that provaccine messages may not or do not increase the intent to immunize, and providing correct educational vaccine information actually decreases both vaccine misperceptions but, counterintuitively, also decreases intent to immunize," she noted (Pediatrics 2014;133:e835-e42).

Session attendee Dr. Kelly Ochoa of Children’s Hospital Los Angeles asked, "Given the evidence from several recent studies showing that educating families about vaccine-preventable illnesses isn’t improving their willingness to get them, what do we do now?"

In the study on provaccine messages, the messages were ineffective mainly among parents whose beliefs were already fixed, Dr. Hough-Telford noted. "We still should do it, but perhaps find out what the parents’ beliefs are before [getting started]."

Session comoderator Dr. Heather Brumberg, a neonatologist in the department of pediatrics at New York Medical College, commented, "Do you think that some education is working, because there is less concern about autism?"

"I do," Dr. Hough-Telford replied. "Between 2006 and 2013, there has been a lot of effort on behalf of pediatricians, the CDC [Centers for Disease Control and Prevention], and the AAP to minimize the concerns about autism ... and to really debunk those myths. So I think that’s why we are seeing this downtick in autism and thimerosal concerns, but it’s very interesting that parents are thinking that immunizations are actually unnecessary. So it’s like they swapped [myths]."

"Have you changed your practice because of the results of the study?" Dr. Brumberg asked.

"Yes, I have, in how I approach parents who are refusing vaccines," said Dr. Hough-Telford, adding that she tries to find out parents’ beliefs before she starts her education efforts, explains to parents why vaccines really are necessary, and alerts them to vaccine-preventable diseases that are occurring in the country.

Dr. Hough-Telford disclosed no relevant conflicts of interest.

VANCOUVER, B.C. – Physician response to parents who refuse to allow their child to be vaccinated is changing, and vaccine refusal is a growing problem, according to an analysis of national survey data.

More often, pediatricians are responding by dismissing these parents and children from their practice.

Researchers led by Dr. Catherine Hough-Telford of the department of pediatrics at the University of Alabama at Birmingham analyzed data from the 2006 and 2013 American Academy of Pediatrics periodic surveys. Analyses were based on 629 and 627 respondents, respectively.

The proportion of pediatricians encountering parents who refused vaccines for their children in the past year rose significantly, from 75% in 2006 to 87% in 2013, a 16% increase she reported at the annual meeting of the Pediatric Academic Societies.

There were decreases in the proportion of refusals in which the stated reason was the child being too small (from 23% to 15%), discomfort (from 42% to 17%), and autism or thimerosal (from 74% to 65%). Meanwhile, there was an increase in the proportion of parents who believed the vaccine was unnecessary (from 63% to 73%).

Nationally, in 2013, the leading reasons parents refused vaccines were believing they were unnecessary and safety concerns, whereas the leading reasons they requested a delay in vaccines were discomfort and concern that a child was getting too many vaccines at one time.

When faced with parental refusal, pediatricians increasingly reported dismissing the parent and patient from their practice: 6% did so in 2006, while 12% did so in 2013 – a 100% increase. In 2013, they had dismissed an average of about three patients for this reason in the past year, at a mean age of about 11 months.

"Vaccine hesitancy is increasing over time. The perception that immunizations are unnecessary has also increased, and the concern for autism or thimerosal has actually declined," commented Dr. Hough-Telford. "Pediatrician response to vaccine hesitancy has also been changing over time, and the rate of dismissal has doubled in the last 7 years."

Educational efforts have had a limited impact in this setting, she noted. "In fact, there was a study that came out this past March showing that provaccine messages may not or do not increase the intent to immunize, and providing correct educational vaccine information actually decreases both vaccine misperceptions but, counterintuitively, also decreases intent to immunize," she noted (Pediatrics 2014;133:e835-e42).

Session attendee Dr. Kelly Ochoa of Children’s Hospital Los Angeles asked, "Given the evidence from several recent studies showing that educating families about vaccine-preventable illnesses isn’t improving their willingness to get them, what do we do now?"

In the study on provaccine messages, the messages were ineffective mainly among parents whose beliefs were already fixed, Dr. Hough-Telford noted. "We still should do it, but perhaps find out what the parents’ beliefs are before [getting started]."

Session comoderator Dr. Heather Brumberg, a neonatologist in the department of pediatrics at New York Medical College, commented, "Do you think that some education is working, because there is less concern about autism?"

"I do," Dr. Hough-Telford replied. "Between 2006 and 2013, there has been a lot of effort on behalf of pediatricians, the CDC [Centers for Disease Control and Prevention], and the AAP to minimize the concerns about autism ... and to really debunk those myths. So I think that’s why we are seeing this downtick in autism and thimerosal concerns, but it’s very interesting that parents are thinking that immunizations are actually unnecessary. So it’s like they swapped [myths]."

"Have you changed your practice because of the results of the study?" Dr. Brumberg asked.

"Yes, I have, in how I approach parents who are refusing vaccines," said Dr. Hough-Telford, adding that she tries to find out parents’ beliefs before she starts her education efforts, explains to parents why vaccines really are necessary, and alerts them to vaccine-preventable diseases that are occurring in the country.

Dr. Hough-Telford disclosed no relevant conflicts of interest.

VANCOUVER, B.C. – Indomethacin helps prevent intraventricular hemorrhages in infants born before 29 weeks to mothers who do not receive a full course of antenatal steroids, according to a small study at Weill Cornell Medical College in New York.

The study included 72 infants born at an average weight of 866 g and 26 weeks’ gestational age. Among the 17 born without optimal maternal courses of antenatal steroids (ANS), the investigators found that just one of eight children dosed with indomethacin developed a severe brain bleed, compared with six of nine who did not get indomethacin. The nonsteroidal anti-inflammatory drug was dosed in the first 6 hours of life – and continued every 24 hours for a total of three doses, if tolerated – at 0.1 mg/kg; it significantly reduced the risk of intraventricular hemorrhage (odds ratio, 14; 95% confidence interval, 1.73-172; P = .04).

M. Alexander Otto/Frontline Medical News

"The administration of indomethacin to premature infants born at 28 weeks or less in the absence of optimal ANS almost eliminated severe IVH [intraventricular hemorrhage] over a 2- year period," concluded the investigators, led by neonatologist Dr. Morgan Spaight, a fellow at Cornell.

"Most of the time, infants [there] get complete ANS courses" when indicated, "and we’ve seen a huge decline in our rates of severe intraventricular hemorrhages. At the same time, we are still seeing born infants that we need to shunt for post-hemorrhagic hydrocephalus; a majority of them were not exposed to antenatal steroids, either at all or [not completely]. This may be the first time indomethacin has been targeted for infants that did not receive optimal antenatal steroids," she said at the annual meeting of the Pediatric Academic Societies.

"We implemented a plan to target these infants specifically" with indomethacin. "We found that it significantly decreased the amount of severe IVH, although there are times we can’t complete the three doses because we are worried about adverse events," such as spontaneous intestinal perforation, she said.

Earlier studies have questioned the long-term benefit of indomethacin, but "there’s a pretty strong connection between severe IVH and bad outcomes, so we feel that preventing" it with indomethacin, when women don’t get a full course of ANS, "has to be a good thing," she said.

Infants who received indomethacin were born, on average, earlier than those who did not (24 vs. 27 weeks) and at lower average weights (652 vs. 972 g).

Dr. Spaight had no disclosures, and the work had no outside funding.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Indomethacin helps prevent intraventricular hemorrhages in infants born before 29 weeks to mothers who do not receive a full course of antenatal steroids, according to a small study at Weill Cornell Medical College in New York.

The study included 72 infants born at an average weight of 866 g and 26 weeks’ gestational age. Among the 17 born without optimal maternal courses of antenatal steroids (ANS), the investigators found that just one of eight children dosed with indomethacin developed a severe brain bleed, compared with six of nine who did not get indomethacin. The nonsteroidal anti-inflammatory drug was dosed in the first 6 hours of life – and continued every 24 hours for a total of three doses, if tolerated – at 0.1 mg/kg; it significantly reduced the risk of intraventricular hemorrhage (odds ratio, 14; 95% confidence interval, 1.73-172; P = .04).

M. Alexander Otto/Frontline Medical News

"The administration of indomethacin to premature infants born at 28 weeks or less in the absence of optimal ANS almost eliminated severe IVH [intraventricular hemorrhage] over a 2- year period," concluded the investigators, led by neonatologist Dr. Morgan Spaight, a fellow at Cornell.

"Most of the time, infants [there] get complete ANS courses" when indicated, "and we’ve seen a huge decline in our rates of severe intraventricular hemorrhages. At the same time, we are still seeing born infants that we need to shunt for post-hemorrhagic hydrocephalus; a majority of them were not exposed to antenatal steroids, either at all or [not completely]. This may be the first time indomethacin has been targeted for infants that did not receive optimal antenatal steroids," she said at the annual meeting of the Pediatric Academic Societies.

"We implemented a plan to target these infants specifically" with indomethacin. "We found that it significantly decreased the amount of severe IVH, although there are times we can’t complete the three doses because we are worried about adverse events," such as spontaneous intestinal perforation, she said.

Earlier studies have questioned the long-term benefit of indomethacin, but "there’s a pretty strong connection between severe IVH and bad outcomes, so we feel that preventing" it with indomethacin, when women don’t get a full course of ANS, "has to be a good thing," she said.

Infants who received indomethacin were born, on average, earlier than those who did not (24 vs. 27 weeks) and at lower average weights (652 vs. 972 g).

Dr. Spaight had no disclosures, and the work had no outside funding.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Indomethacin helps prevent intraventricular hemorrhages in infants born before 29 weeks to mothers who do not receive a full course of antenatal steroids, according to a small study at Weill Cornell Medical College in New York.

The study included 72 infants born at an average weight of 866 g and 26 weeks’ gestational age. Among the 17 born without optimal maternal courses of antenatal steroids (ANS), the investigators found that just one of eight children dosed with indomethacin developed a severe brain bleed, compared with six of nine who did not get indomethacin. The nonsteroidal anti-inflammatory drug was dosed in the first 6 hours of life – and continued every 24 hours for a total of three doses, if tolerated – at 0.1 mg/kg; it significantly reduced the risk of intraventricular hemorrhage (odds ratio, 14; 95% confidence interval, 1.73-172; P = .04).

M. Alexander Otto/Frontline Medical News

"The administration of indomethacin to premature infants born at 28 weeks or less in the absence of optimal ANS almost eliminated severe IVH [intraventricular hemorrhage] over a 2- year period," concluded the investigators, led by neonatologist Dr. Morgan Spaight, a fellow at Cornell.

"Most of the time, infants [there] get complete ANS courses" when indicated, "and we’ve seen a huge decline in our rates of severe intraventricular hemorrhages. At the same time, we are still seeing born infants that we need to shunt for post-hemorrhagic hydrocephalus; a majority of them were not exposed to antenatal steroids, either at all or [not completely]. This may be the first time indomethacin has been targeted for infants that did not receive optimal antenatal steroids," she said at the annual meeting of the Pediatric Academic Societies.

"We implemented a plan to target these infants specifically" with indomethacin. "We found that it significantly decreased the amount of severe IVH, although there are times we can’t complete the three doses because we are worried about adverse events," such as spontaneous intestinal perforation, she said.

Earlier studies have questioned the long-term benefit of indomethacin, but "there’s a pretty strong connection between severe IVH and bad outcomes, so we feel that preventing" it with indomethacin, when women don’t get a full course of ANS, "has to be a good thing," she said.

Infants who received indomethacin were born, on average, earlier than those who did not (24 vs. 27 weeks) and at lower average weights (652 vs. 972 g).

Dr. Spaight had no disclosures, and the work had no outside funding.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – When there isn’t time for a full course of prenatal steroids before early preterm birth, a partial course is better than nothing, according to investigators at the National Institute of Child Health and Human Development’s Neonatal Research Network.

In a study of 5,248 infants born between 24 and 27 weeks’ gestational age who were alive at 18-22 months, 17.6% (120/683) whose mothers got no prenatal steroids (PNS) before delivery had cerebral palsy, a statistically significant difference from the 13% (178/1,369) whose mothers got one dose of PNS – betamethasone in almost all cases – and the 10.5% (336/3,196) whose mothers got the full course of two betamethasone doses, 24 hours apart.

Similarly, intact survival at follow-up – survival free of hearing loss, blindness, and cerebral palsy, plus scores greater than 85 points on the Bayley Scales of Infant and Toddler Development III – was 55% in the no-PNS infants, 65% in the partial-PNS infants, and 69% in the PNS infants who got a full course, all statistically significant differences.

Compared with full-course PNS infants, those who got no PNS (odds ratio, 1.4; 95% confidence interval, 1.2-1.7) or partial PNS (OR, 1.2; 95% CI, 1.1-1.4) were more likely to have died or have neurodevelopmental impairment at 18-22 months.

Earlier results of the study, at discharge, were largely the same, with greater survival and fewer neurodevelopmental impairments when mothers got at least one dose of PNS before delivery.

The reason was that even one dose before delivery helped prevent both brain hemorrhages and cystic periventricular leucomalacia, the investigators found.

Prenatal steroids have long been known to help prevent both problems. What’s new in the findings is confirmation that even one dose helps.

"The intention is always to give a complete course," but when imminent delivery makes that impossible, even "one dose is better than no dose. The results help us counsel parents when we know" what dose children got before delivery. Also, "for research, the question shouldn’t be [prenatal] steroids, yes or no," but the completeness of the course, said lead investigator and neonatologist Sanjay Chawla of the department of pediatrics at the Children’s Hospital of Michigan, Detroit.

"Some people say, ‘She’s going to C-section in an hour, so it doesn’t matter’" That’s wrong. "One shot [of betamethasone] is still better than nothing. It makes a difference," said Dr. Nathalie Maitre, a neonatologist at Vanderbilt University in Nashville, Tenn., who helped moderate Dr. Chawla’s presentation at the Pediatric Academic Societies annual meeting.

There were some significant differences between the groups. No-PNS infants were born a bit earlier, at a mean of 24 weeks instead of about 25 weeks, and were a bit lighter at birth, 690 g instead of almost 800 g in the partial and full PNS groups. They were also a bit more likely to be black and on Medicaid.

Also, partial and full PNS infants were a bit more likely to be born by C-section. Boys and girls were split 50-50 in all three groups.

Dr. Chawla and Dr. Maitre said they had no relevant financial disclosures. The National Institutes of Health funded the work.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – When there isn’t time for a full course of prenatal steroids before early preterm birth, a partial course is better than nothing, according to investigators at the National Institute of Child Health and Human Development’s Neonatal Research Network.

In a study of 5,248 infants born between 24 and 27 weeks’ gestational age who were alive at 18-22 months, 17.6% (120/683) whose mothers got no prenatal steroids (PNS) before delivery had cerebral palsy, a statistically significant difference from the 13% (178/1,369) whose mothers got one dose of PNS – betamethasone in almost all cases – and the 10.5% (336/3,196) whose mothers got the full course of two betamethasone doses, 24 hours apart.

Similarly, intact survival at follow-up – survival free of hearing loss, blindness, and cerebral palsy, plus scores greater than 85 points on the Bayley Scales of Infant and Toddler Development III – was 55% in the no-PNS infants, 65% in the partial-PNS infants, and 69% in the PNS infants who got a full course, all statistically significant differences.

Compared with full-course PNS infants, those who got no PNS (odds ratio, 1.4; 95% confidence interval, 1.2-1.7) or partial PNS (OR, 1.2; 95% CI, 1.1-1.4) were more likely to have died or have neurodevelopmental impairment at 18-22 months.

Earlier results of the study, at discharge, were largely the same, with greater survival and fewer neurodevelopmental impairments when mothers got at least one dose of PNS before delivery.

The reason was that even one dose before delivery helped prevent both brain hemorrhages and cystic periventricular leucomalacia, the investigators found.

Prenatal steroids have long been known to help prevent both problems. What’s new in the findings is confirmation that even one dose helps.

"The intention is always to give a complete course," but when imminent delivery makes that impossible, even "one dose is better than no dose. The results help us counsel parents when we know" what dose children got before delivery. Also, "for research, the question shouldn’t be [prenatal] steroids, yes or no," but the completeness of the course, said lead investigator and neonatologist Sanjay Chawla of the department of pediatrics at the Children’s Hospital of Michigan, Detroit.

"Some people say, ‘She’s going to C-section in an hour, so it doesn’t matter’" That’s wrong. "One shot [of betamethasone] is still better than nothing. It makes a difference," said Dr. Nathalie Maitre, a neonatologist at Vanderbilt University in Nashville, Tenn., who helped moderate Dr. Chawla’s presentation at the Pediatric Academic Societies annual meeting.

There were some significant differences between the groups. No-PNS infants were born a bit earlier, at a mean of 24 weeks instead of about 25 weeks, and were a bit lighter at birth, 690 g instead of almost 800 g in the partial and full PNS groups. They were also a bit more likely to be black and on Medicaid.

Also, partial and full PNS infants were a bit more likely to be born by C-section. Boys and girls were split 50-50 in all three groups.

Dr. Chawla and Dr. Maitre said they had no relevant financial disclosures. The National Institutes of Health funded the work.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – When there isn’t time for a full course of prenatal steroids before early preterm birth, a partial course is better than nothing, according to investigators at the National Institute of Child Health and Human Development’s Neonatal Research Network.

In a study of 5,248 infants born between 24 and 27 weeks’ gestational age who were alive at 18-22 months, 17.6% (120/683) whose mothers got no prenatal steroids (PNS) before delivery had cerebral palsy, a statistically significant difference from the 13% (178/1,369) whose mothers got one dose of PNS – betamethasone in almost all cases – and the 10.5% (336/3,196) whose mothers got the full course of two betamethasone doses, 24 hours apart.

Similarly, intact survival at follow-up – survival free of hearing loss, blindness, and cerebral palsy, plus scores greater than 85 points on the Bayley Scales of Infant and Toddler Development III – was 55% in the no-PNS infants, 65% in the partial-PNS infants, and 69% in the PNS infants who got a full course, all statistically significant differences.

Compared with full-course PNS infants, those who got no PNS (odds ratio, 1.4; 95% confidence interval, 1.2-1.7) or partial PNS (OR, 1.2; 95% CI, 1.1-1.4) were more likely to have died or have neurodevelopmental impairment at 18-22 months.

Earlier results of the study, at discharge, were largely the same, with greater survival and fewer neurodevelopmental impairments when mothers got at least one dose of PNS before delivery.

The reason was that even one dose before delivery helped prevent both brain hemorrhages and cystic periventricular leucomalacia, the investigators found.

Prenatal steroids have long been known to help prevent both problems. What’s new in the findings is confirmation that even one dose helps.

"The intention is always to give a complete course," but when imminent delivery makes that impossible, even "one dose is better than no dose. The results help us counsel parents when we know" what dose children got before delivery. Also, "for research, the question shouldn’t be [prenatal] steroids, yes or no," but the completeness of the course, said lead investigator and neonatologist Sanjay Chawla of the department of pediatrics at the Children’s Hospital of Michigan, Detroit.

"Some people say, ‘She’s going to C-section in an hour, so it doesn’t matter’" That’s wrong. "One shot [of betamethasone] is still better than nothing. It makes a difference," said Dr. Nathalie Maitre, a neonatologist at Vanderbilt University in Nashville, Tenn., who helped moderate Dr. Chawla’s presentation at the Pediatric Academic Societies annual meeting.

There were some significant differences between the groups. No-PNS infants were born a bit earlier, at a mean of 24 weeks instead of about 25 weeks, and were a bit lighter at birth, 690 g instead of almost 800 g in the partial and full PNS groups. They were also a bit more likely to be black and on Medicaid.

Also, partial and full PNS infants were a bit more likely to be born by C-section. Boys and girls were split 50-50 in all three groups.

Dr. Chawla and Dr. Maitre said they had no relevant financial disclosures. The National Institutes of Health funded the work.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Treatment of electrographic seizures in neonates with hypoxic-ischemic encephalopathy reduces their seizure burden, although the impact on neurodevelopmental outcomes remains unclear, new data show.

Investigators led by Dr. Shamik Trivedi, a neonatology fellow at St. Louis Children’s Hospital, conducted a randomized trial among 69 neonates of at least 36 weeks’ gestational age who had moderate to severe hypoxic-ischemic encephalopathy (HIE).

In half of the neonates, clinicians treated all seizures detected by continuous amplitude-integrated electroencephalographic (EEG) monitoring; in the other half, they treated only those seizures that became clinically apparent.

Results reported in a late-breaker session at the annual meeting of the Pediatric Academic Societies showed that among neonates who did not experience status epilepticus, basing treatment on the EEG rather than on clinical observation yielded a 22% lower burden of electrographic seizures. In addition, the time to seizure treatment was reduced by about half.

The groups did not differ significantly with respect to neurodevelopmental outcomes at 2 years among neonates who had seizures and survived, but the investigators attributed that to the small size of the trial.

"We believe that a multicenter randomized controlled trial with a larger cohort would show a significant difference in neurodevelopmental outcome between the clinical and EEG groups," Dr. Trivedi said.

Fully 60% of seizures in neonates with HIE are subclinical, he noted in an interview. "So a lot of times, babies may be having seizures and you have no idea."

Treatment based solely on clinical observation can result in electromechanical dissociation, whereby seizure activity is no longer clinically evident. "So if you are not seeing any sort of clinical activity of seizures, then you may not have any concern, whereas they could be seizing for a prolonged period of time," he said.

Despite the encouraging results, the findings are too preliminary to warrant a change in practice at this time, according to Dr. Trivedi.

"This was a very important start to this [issue], and hopefully it will stimulate discussion about having a large multicenter clinical trial," session comoderator Dr. Christine A. Gleason, chief of the division of neonatology at Seattle Children’s Hospital, said in an interview. "We all worry about it and we always wonder if some of these little movements are seizures or not. And sometimes, there are no movements, and there it is – it’s a seizure."

Not all neonatology units have the capability for continuous EEG monitoring, she said. "So if it is demonstrated that that can improve the outcome ... then I think that would compel us to think about having additional resources so that we could do continuous monitoring of the EEG for seizures."

In the trial, all of the infants had continuous EEG monitoring for up to 96 hours. In the EEG seizure treatment group, software alerted clinicians of any electrographic seizures, which were treated if confirmed by an epileptologist. In the clinical seizure treatment group, seizures were diagnosed and treated on the basis of clinical observation, except when clinicians had concern about status epilepticus, in which case they had access to a 1-hour EEG.

Overall, 43% of neonates in the EEG seizure treatment group had an electrographic seizure, compared with 59% of neonates in the clinical seizure treatment group.

The former group had a lower electrographic seizure burden (quantified as log units of continuous seizure activity in seconds) among neonates who did not have status epilepticus (6.0 vs. 7.7), fewer electrographic seizure events (7 vs. 12), and a shorter time to seizure treatment (79 vs 170 minutes). There also was a nonsignificantly lower seizure burden in the EEG seizure treatment group among all infants (7.4 vs. 8.4).

The groups were statistically indistinguishable with respect to the rate of death (five total, all among infants with status epilepticus and severe encephalopathy), time to oral feeding in survivors, and durations of mechanical ventilation and hospital stay.

Twenty-four neonates who experienced electrographic seizures survived to follow-up and were evaluated with the Infant and Toddler Development scales of the Bayley-III tool at 18-24 months of age. Within this subset, there was no significant difference in cognitive, motor, or language scores between the EEG and clinical seizure treatment groups. However, in the subset as a whole, higher cumulative seizure burden correlated with significantly poorer scores.

The investigators have not yet looked at the correlation of EEG and clinical seizure events in the trial, according to Dr. Trivedi.

Dr. Trivedi disclosed no relevant conflicts of interest.

VANCOUVER, B.C. – Treatment of electrographic seizures in neonates with hypoxic-ischemic encephalopathy reduces their seizure burden, although the impact on neurodevelopmental outcomes remains unclear, new data show.

Investigators led by Dr. Shamik Trivedi, a neonatology fellow at St. Louis Children’s Hospital, conducted a randomized trial among 69 neonates of at least 36 weeks’ gestational age who had moderate to severe hypoxic-ischemic encephalopathy (HIE).

In half of the neonates, clinicians treated all seizures detected by continuous amplitude-integrated electroencephalographic (EEG) monitoring; in the other half, they treated only those seizures that became clinically apparent.

Results reported in a late-breaker session at the annual meeting of the Pediatric Academic Societies showed that among neonates who did not experience status epilepticus, basing treatment on the EEG rather than on clinical observation yielded a 22% lower burden of electrographic seizures. In addition, the time to seizure treatment was reduced by about half.

The groups did not differ significantly with respect to neurodevelopmental outcomes at 2 years among neonates who had seizures and survived, but the investigators attributed that to the small size of the trial.

"We believe that a multicenter randomized controlled trial with a larger cohort would show a significant difference in neurodevelopmental outcome between the clinical and EEG groups," Dr. Trivedi said.

Fully 60% of seizures in neonates with HIE are subclinical, he noted in an interview. "So a lot of times, babies may be having seizures and you have no idea."

Treatment based solely on clinical observation can result in electromechanical dissociation, whereby seizure activity is no longer clinically evident. "So if you are not seeing any sort of clinical activity of seizures, then you may not have any concern, whereas they could be seizing for a prolonged period of time," he said.

Despite the encouraging results, the findings are too preliminary to warrant a change in practice at this time, according to Dr. Trivedi.

"This was a very important start to this [issue], and hopefully it will stimulate discussion about having a large multicenter clinical trial," session comoderator Dr. Christine A. Gleason, chief of the division of neonatology at Seattle Children’s Hospital, said in an interview. "We all worry about it and we always wonder if some of these little movements are seizures or not. And sometimes, there are no movements, and there it is – it’s a seizure."

Not all neonatology units have the capability for continuous EEG monitoring, she said. "So if it is demonstrated that that can improve the outcome ... then I think that would compel us to think about having additional resources so that we could do continuous monitoring of the EEG for seizures."

In the trial, all of the infants had continuous EEG monitoring for up to 96 hours. In the EEG seizure treatment group, software alerted clinicians of any electrographic seizures, which were treated if confirmed by an epileptologist. In the clinical seizure treatment group, seizures were diagnosed and treated on the basis of clinical observation, except when clinicians had concern about status epilepticus, in which case they had access to a 1-hour EEG.

Overall, 43% of neonates in the EEG seizure treatment group had an electrographic seizure, compared with 59% of neonates in the clinical seizure treatment group.

The former group had a lower electrographic seizure burden (quantified as log units of continuous seizure activity in seconds) among neonates who did not have status epilepticus (6.0 vs. 7.7), fewer electrographic seizure events (7 vs. 12), and a shorter time to seizure treatment (79 vs 170 minutes). There also was a nonsignificantly lower seizure burden in the EEG seizure treatment group among all infants (7.4 vs. 8.4).

The groups were statistically indistinguishable with respect to the rate of death (five total, all among infants with status epilepticus and severe encephalopathy), time to oral feeding in survivors, and durations of mechanical ventilation and hospital stay.

Twenty-four neonates who experienced electrographic seizures survived to follow-up and were evaluated with the Infant and Toddler Development scales of the Bayley-III tool at 18-24 months of age. Within this subset, there was no significant difference in cognitive, motor, or language scores between the EEG and clinical seizure treatment groups. However, in the subset as a whole, higher cumulative seizure burden correlated with significantly poorer scores.

The investigators have not yet looked at the correlation of EEG and clinical seizure events in the trial, according to Dr. Trivedi.

Dr. Trivedi disclosed no relevant conflicts of interest.

VANCOUVER, B.C. – Treatment of electrographic seizures in neonates with hypoxic-ischemic encephalopathy reduces their seizure burden, although the impact on neurodevelopmental outcomes remains unclear, new data show.

Investigators led by Dr. Shamik Trivedi, a neonatology fellow at St. Louis Children’s Hospital, conducted a randomized trial among 69 neonates of at least 36 weeks’ gestational age who had moderate to severe hypoxic-ischemic encephalopathy (HIE).

In half of the neonates, clinicians treated all seizures detected by continuous amplitude-integrated electroencephalographic (EEG) monitoring; in the other half, they treated only those seizures that became clinically apparent.

Results reported in a late-breaker session at the annual meeting of the Pediatric Academic Societies showed that among neonates who did not experience status epilepticus, basing treatment on the EEG rather than on clinical observation yielded a 22% lower burden of electrographic seizures. In addition, the time to seizure treatment was reduced by about half.

The groups did not differ significantly with respect to neurodevelopmental outcomes at 2 years among neonates who had seizures and survived, but the investigators attributed that to the small size of the trial.

"We believe that a multicenter randomized controlled trial with a larger cohort would show a significant difference in neurodevelopmental outcome between the clinical and EEG groups," Dr. Trivedi said.

Fully 60% of seizures in neonates with HIE are subclinical, he noted in an interview. "So a lot of times, babies may be having seizures and you have no idea."

Treatment based solely on clinical observation can result in electromechanical dissociation, whereby seizure activity is no longer clinically evident. "So if you are not seeing any sort of clinical activity of seizures, then you may not have any concern, whereas they could be seizing for a prolonged period of time," he said.

Despite the encouraging results, the findings are too preliminary to warrant a change in practice at this time, according to Dr. Trivedi.

"This was a very important start to this [issue], and hopefully it will stimulate discussion about having a large multicenter clinical trial," session comoderator Dr. Christine A. Gleason, chief of the division of neonatology at Seattle Children’s Hospital, said in an interview. "We all worry about it and we always wonder if some of these little movements are seizures or not. And sometimes, there are no movements, and there it is – it’s a seizure."

Not all neonatology units have the capability for continuous EEG monitoring, she said. "So if it is demonstrated that that can improve the outcome ... then I think that would compel us to think about having additional resources so that we could do continuous monitoring of the EEG for seizures."

In the trial, all of the infants had continuous EEG monitoring for up to 96 hours. In the EEG seizure treatment group, software alerted clinicians of any electrographic seizures, which were treated if confirmed by an epileptologist. In the clinical seizure treatment group, seizures were diagnosed and treated on the basis of clinical observation, except when clinicians had concern about status epilepticus, in which case they had access to a 1-hour EEG.

Overall, 43% of neonates in the EEG seizure treatment group had an electrographic seizure, compared with 59% of neonates in the clinical seizure treatment group.

The former group had a lower electrographic seizure burden (quantified as log units of continuous seizure activity in seconds) among neonates who did not have status epilepticus (6.0 vs. 7.7), fewer electrographic seizure events (7 vs. 12), and a shorter time to seizure treatment (79 vs 170 minutes). There also was a nonsignificantly lower seizure burden in the EEG seizure treatment group among all infants (7.4 vs. 8.4).

The groups were statistically indistinguishable with respect to the rate of death (five total, all among infants with status epilepticus and severe encephalopathy), time to oral feeding in survivors, and durations of mechanical ventilation and hospital stay.

Twenty-four neonates who experienced electrographic seizures survived to follow-up and were evaluated with the Infant and Toddler Development scales of the Bayley-III tool at 18-24 months of age. Within this subset, there was no significant difference in cognitive, motor, or language scores between the EEG and clinical seizure treatment groups. However, in the subset as a whole, higher cumulative seizure burden correlated with significantly poorer scores.

The investigators have not yet looked at the correlation of EEG and clinical seizure events in the trial, according to Dr. Trivedi.

Dr. Trivedi disclosed no relevant conflicts of interest.