Susan London

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. – 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.

SCOTTSDALE, ARIZ. – Obstetric risk factors for stage II anterior and posterior pelvic organ prolapse are essentially the same, but symptoms differ, according to a cohort study reported at the annual meeting of the Society of Gynecologic Surgeons.

Investigators led by Dr. MaryAnn Wilbur of the department of obstetrics and gynecology at Johns Hopkins University, Baltimore, analyzed data from women who were 5-10 years out from a first delivery, comparing 85 women with posterior prolapse (with or without concomitant anterior prolapse), 334 women with isolated anterior prolapse, and 1,078 women with no prolapse.

The results showed that having had a vaginal delivery was a risk factor for both posterior and anterior prolapse. But the women with posterior prolapse were significantly more likely to report a loss of gas from the rectum, having to push on the vagina to complete a bowel movement, having a sensation of bulge, and having asked a physician for help because of their symptoms.

"Not surprisingly, prolapse was associated with vaginal delivery, but when we compare anterior versus posterior prolapse, there were no differences in terms of obstetric risk factors, at least that we could perceive in this study," Dr. Wilbur commented. "But the symptomatology was different between those two groups," although the reasons for this difference were not readily apparent.

The investigators analyzed data collected at enrollment, 5-10 years after a first delivery, from women in the Mothers’ Outcomes After Delivery cohort. Most had had their delivery at Greater Baltimore Medical Center, a large community hospital.

The women’s obstetric history was reviewed, they underwent examination including the pelvic organ prolapse quantification (POP-Q) system assessment, and they completed validated measures of symptoms, including the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ) and the Colorectal-Anal Impact Questionnaire (CRAIQ).

The investigators categorized the women as having posterior prolapse (with a point A posterior value on the POP-Q greater than or equal to –1) with or without anterior prolapse, isolated anterior prolapse (with a point A anterior value greater than or equal to –1), or no prolapse.

It was not possible to study isolated posterior prolapse because only 20 women had posterior prolapse without concomitant anterior prolapse, Dr. Wilbur explained at the meeting, which was jointly sponsored by the American College of Surgeons.

Compared with the no-prolapse group, both the posterior and anterior prolapse groups were more likely to have completed the first stage of labor (85% and 76% vs. 53%) and to have had a vaginal delivery (79% and 70% vs. 40%), she reported.

The two prolapse groups were similar with respect to these and a variety of other obstetric factors, such as having a prolonged second stage of labor, having an infant weighing at least 4,000 g, having an operative delivery, having an episiotomy, and experiencing perineal tears.

But relative to their counterparts with anterior prolapse, women with posterior prolapse were more likely to report a loss of gas from the rectum (odds ratio, 1.79), having to push on the vagina to complete a bowel movement (1.72), having a sensation of bulge (2.58), and having asked a physician for help because of prolapse symptoms (3.24).

Women with anterior prolapse were similar to women with no prolapse on most of these measures. The exception was that women without prolapse were, not surprisingly, less likely to have asked a physician for help (odds ratio, 0.27).

"We are following these women over time. So those 1,497 women came in for the first visit, but as of today we have 3,840 person-visits, and in the final manuscript, we did do generalized estimating equations where we followed those trends over time," Dr. Wilbur commented. "They are actually very similar to the enrollment data."

The study’s main shortcoming is its potential lack of generalizability, she said. "Greater Baltimore Medical Center does deliver women who are mostly white and relatively affluent in comparison to the general American population."

Dr. Wilbur disclosed no relevant conflicts of interest

SCOTTSDALE, ARIZ. – Obstetric risk factors for stage II anterior and posterior pelvic organ prolapse are essentially the same, but symptoms differ, according to a cohort study reported at the annual meeting of the Society of Gynecologic Surgeons.

Investigators led by Dr. MaryAnn Wilbur of the department of obstetrics and gynecology at Johns Hopkins University, Baltimore, analyzed data from women who were 5-10 years out from a first delivery, comparing 85 women with posterior prolapse (with or without concomitant anterior prolapse), 334 women with isolated anterior prolapse, and 1,078 women with no prolapse.

The results showed that having had a vaginal delivery was a risk factor for both posterior and anterior prolapse. But the women with posterior prolapse were significantly more likely to report a loss of gas from the rectum, having to push on the vagina to complete a bowel movement, having a sensation of bulge, and having asked a physician for help because of their symptoms.

"Not surprisingly, prolapse was associated with vaginal delivery, but when we compare anterior versus posterior prolapse, there were no differences in terms of obstetric risk factors, at least that we could perceive in this study," Dr. Wilbur commented. "But the symptomatology was different between those two groups," although the reasons for this difference were not readily apparent.

The investigators analyzed data collected at enrollment, 5-10 years after a first delivery, from women in the Mothers’ Outcomes After Delivery cohort. Most had had their delivery at Greater Baltimore Medical Center, a large community hospital.

The women’s obstetric history was reviewed, they underwent examination including the pelvic organ prolapse quantification (POP-Q) system assessment, and they completed validated measures of symptoms, including the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ) and the Colorectal-Anal Impact Questionnaire (CRAIQ).

The investigators categorized the women as having posterior prolapse (with a point A posterior value on the POP-Q greater than or equal to –1) with or without anterior prolapse, isolated anterior prolapse (with a point A anterior value greater than or equal to –1), or no prolapse.

It was not possible to study isolated posterior prolapse because only 20 women had posterior prolapse without concomitant anterior prolapse, Dr. Wilbur explained at the meeting, which was jointly sponsored by the American College of Surgeons.

Compared with the no-prolapse group, both the posterior and anterior prolapse groups were more likely to have completed the first stage of labor (85% and 76% vs. 53%) and to have had a vaginal delivery (79% and 70% vs. 40%), she reported.

The two prolapse groups were similar with respect to these and a variety of other obstetric factors, such as having a prolonged second stage of labor, having an infant weighing at least 4,000 g, having an operative delivery, having an episiotomy, and experiencing perineal tears.

But relative to their counterparts with anterior prolapse, women with posterior prolapse were more likely to report a loss of gas from the rectum (odds ratio, 1.79), having to push on the vagina to complete a bowel movement (1.72), having a sensation of bulge (2.58), and having asked a physician for help because of prolapse symptoms (3.24).

Women with anterior prolapse were similar to women with no prolapse on most of these measures. The exception was that women without prolapse were, not surprisingly, less likely to have asked a physician for help (odds ratio, 0.27).

"We are following these women over time. So those 1,497 women came in for the first visit, but as of today we have 3,840 person-visits, and in the final manuscript, we did do generalized estimating equations where we followed those trends over time," Dr. Wilbur commented. "They are actually very similar to the enrollment data."

The study’s main shortcoming is its potential lack of generalizability, she said. "Greater Baltimore Medical Center does deliver women who are mostly white and relatively affluent in comparison to the general American population."

Dr. Wilbur disclosed no relevant conflicts of interest

SCOTTSDALE, ARIZ. – Obstetric risk factors for stage II anterior and posterior pelvic organ prolapse are essentially the same, but symptoms differ, according to a cohort study reported at the annual meeting of the Society of Gynecologic Surgeons.

Investigators led by Dr. MaryAnn Wilbur of the department of obstetrics and gynecology at Johns Hopkins University, Baltimore, analyzed data from women who were 5-10 years out from a first delivery, comparing 85 women with posterior prolapse (with or without concomitant anterior prolapse), 334 women with isolated anterior prolapse, and 1,078 women with no prolapse.

The results showed that having had a vaginal delivery was a risk factor for both posterior and anterior prolapse. But the women with posterior prolapse were significantly more likely to report a loss of gas from the rectum, having to push on the vagina to complete a bowel movement, having a sensation of bulge, and having asked a physician for help because of their symptoms.

"Not surprisingly, prolapse was associated with vaginal delivery, but when we compare anterior versus posterior prolapse, there were no differences in terms of obstetric risk factors, at least that we could perceive in this study," Dr. Wilbur commented. "But the symptomatology was different between those two groups," although the reasons for this difference were not readily apparent.

The investigators analyzed data collected at enrollment, 5-10 years after a first delivery, from women in the Mothers’ Outcomes After Delivery cohort. Most had had their delivery at Greater Baltimore Medical Center, a large community hospital.

The women’s obstetric history was reviewed, they underwent examination including the pelvic organ prolapse quantification (POP-Q) system assessment, and they completed validated measures of symptoms, including the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ) and the Colorectal-Anal Impact Questionnaire (CRAIQ).

The investigators categorized the women as having posterior prolapse (with a point A posterior value on the POP-Q greater than or equal to –1) with or without anterior prolapse, isolated anterior prolapse (with a point A anterior value greater than or equal to –1), or no prolapse.

It was not possible to study isolated posterior prolapse because only 20 women had posterior prolapse without concomitant anterior prolapse, Dr. Wilbur explained at the meeting, which was jointly sponsored by the American College of Surgeons.

Compared with the no-prolapse group, both the posterior and anterior prolapse groups were more likely to have completed the first stage of labor (85% and 76% vs. 53%) and to have had a vaginal delivery (79% and 70% vs. 40%), she reported.

The two prolapse groups were similar with respect to these and a variety of other obstetric factors, such as having a prolonged second stage of labor, having an infant weighing at least 4,000 g, having an operative delivery, having an episiotomy, and experiencing perineal tears.

But relative to their counterparts with anterior prolapse, women with posterior prolapse were more likely to report a loss of gas from the rectum (odds ratio, 1.79), having to push on the vagina to complete a bowel movement (1.72), having a sensation of bulge (2.58), and having asked a physician for help because of prolapse symptoms (3.24).

Women with anterior prolapse were similar to women with no prolapse on most of these measures. The exception was that women without prolapse were, not surprisingly, less likely to have asked a physician for help (odds ratio, 0.27).

"We are following these women over time. So those 1,497 women came in for the first visit, but as of today we have 3,840 person-visits, and in the final manuscript, we did do generalized estimating equations where we followed those trends over time," Dr. Wilbur commented. "They are actually very similar to the enrollment data."

The study’s main shortcoming is its potential lack of generalizability, she said. "Greater Baltimore Medical Center does deliver women who are mostly white and relatively affluent in comparison to the general American population."

Dr. Wilbur 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. – 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. – 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.

VANCOUVER – The long-standing practice of endotracheal suctioning in nonvigorous neonates born with meconium-stained amniotic fluid does not reduce adverse outcomes, finds an open-label, randomized trial conducted among 175 term singleton neonates at a tertiary care hospital in India.

Although this practice has been used since the 1970s, it has not been rigorously tested in randomized trials, noted lead investigator Dr. Sushma Nangia, a neonatologist and professor of pediatrics at Lady Hardinge Medical College in New Delhi.

In a statement addressing neonatal resuscitation, the American Academy of Pediatrics and American Heart Association found "insufficient evidence to recommend a change in the current practice" (Pediatrics. 2010;126:e1400-13).

Trial results showed that 26% of the neonates who were not intubated and suctioned developed meconium aspiration syndrome, compared with 32% of their intubated and suctioned counterparts, a nonsignificant difference, researchers reported at the annual meeting of the Pediatric Academic Societies. The distribution of syndrome severity was also statistically indistinguishable.

Additionally, 5% of the neonates in the nonsuctioned group and 10% in the suctioned group died, another nonsignificant difference.

Rates of other adverse outcomes also were essentially the same, except that the nonsuctioned neonates actually had significantly shorter durations of respiratory distress (19 vs. 43 hours) and mechanical ventilation (25 vs. 43 hours).

"In nonvigorous full-term neonates born to mothers with meconium-stained amniotic fluid, our study demonstrated that not performing endotracheal suction to clear the airway during neonatal resuscitation did not increase the incidence of meconium aspiration syndrome or predispose to death," Dr. Nangia commented.

Session attendee Dr. Martin Keszler of Brown University, Providence, R.I., said, "Congratulations for having the courage to do this important study. All of us have been wondering about it, but it’s a practice so deeply ingrained that at least in our litigious environment, it would be very difficult to do. ... I think that this is a very important study because it can reassure future investigators to get the courage up to do this very important work."

"Certainly, it was encouraging that [no endotracheal suctioning] was no worse than control. It even seems that it was better. ... I wonder if you could speculate ..., is the intervention truly harmful and are we really better off leaving them alone?" he asked.

"We really don’t have the numbers that are required to do kind of an equivalence study," Dr. Nangia replied. "So this is just the pilot where we have 175 babies."

Another attendee asked, "With these results, can you give us an idea of the sample size you need to prove [the findings] particularly in the babies with thick meconium? How many babies will you need to test the hypothesis?"

Given the incidence of meconium aspiration syndrome, "from a national perinatal database, we think we would require about 480 babies to study the difference," said Dr. Nangia.

Dr. Nangia disclosed no relevant conflicts of interest.

VANCOUVER – The long-standing practice of endotracheal suctioning in nonvigorous neonates born with meconium-stained amniotic fluid does not reduce adverse outcomes, finds an open-label, randomized trial conducted among 175 term singleton neonates at a tertiary care hospital in India.

Although this practice has been used since the 1970s, it has not been rigorously tested in randomized trials, noted lead investigator Dr. Sushma Nangia, a neonatologist and professor of pediatrics at Lady Hardinge Medical College in New Delhi.

In a statement addressing neonatal resuscitation, the American Academy of Pediatrics and American Heart Association found "insufficient evidence to recommend a change in the current practice" (Pediatrics. 2010;126:e1400-13).

Trial results showed that 26% of the neonates who were not intubated and suctioned developed meconium aspiration syndrome, compared with 32% of their intubated and suctioned counterparts, a nonsignificant difference, researchers reported at the annual meeting of the Pediatric Academic Societies. The distribution of syndrome severity was also statistically indistinguishable.

Additionally, 5% of the neonates in the nonsuctioned group and 10% in the suctioned group died, another nonsignificant difference.

Rates of other adverse outcomes also were essentially the same, except that the nonsuctioned neonates actually had significantly shorter durations of respiratory distress (19 vs. 43 hours) and mechanical ventilation (25 vs. 43 hours).

"In nonvigorous full-term neonates born to mothers with meconium-stained amniotic fluid, our study demonstrated that not performing endotracheal suction to clear the airway during neonatal resuscitation did not increase the incidence of meconium aspiration syndrome or predispose to death," Dr. Nangia commented.

Session attendee Dr. Martin Keszler of Brown University, Providence, R.I., said, "Congratulations for having the courage to do this important study. All of us have been wondering about it, but it’s a practice so deeply ingrained that at least in our litigious environment, it would be very difficult to do. ... I think that this is a very important study because it can reassure future investigators to get the courage up to do this very important work."

"Certainly, it was encouraging that [no endotracheal suctioning] was no worse than control. It even seems that it was better. ... I wonder if you could speculate ..., is the intervention truly harmful and are we really better off leaving them alone?" he asked.

"We really don’t have the numbers that are required to do kind of an equivalence study," Dr. Nangia replied. "So this is just the pilot where we have 175 babies."

Another attendee asked, "With these results, can you give us an idea of the sample size you need to prove [the findings] particularly in the babies with thick meconium? How many babies will you need to test the hypothesis?"

Given the incidence of meconium aspiration syndrome, "from a national perinatal database, we think we would require about 480 babies to study the difference," said Dr. Nangia.

Dr. Nangia disclosed no relevant conflicts of interest.

VANCOUVER – The long-standing practice of endotracheal suctioning in nonvigorous neonates born with meconium-stained amniotic fluid does not reduce adverse outcomes, finds an open-label, randomized trial conducted among 175 term singleton neonates at a tertiary care hospital in India.

Although this practice has been used since the 1970s, it has not been rigorously tested in randomized trials, noted lead investigator Dr. Sushma Nangia, a neonatologist and professor of pediatrics at Lady Hardinge Medical College in New Delhi.

In a statement addressing neonatal resuscitation, the American Academy of Pediatrics and American Heart Association found "insufficient evidence to recommend a change in the current practice" (Pediatrics. 2010;126:e1400-13).

Trial results showed that 26% of the neonates who were not intubated and suctioned developed meconium aspiration syndrome, compared with 32% of their intubated and suctioned counterparts, a nonsignificant difference, researchers reported at the annual meeting of the Pediatric Academic Societies. The distribution of syndrome severity was also statistically indistinguishable.

Additionally, 5% of the neonates in the nonsuctioned group and 10% in the suctioned group died, another nonsignificant difference.

Rates of other adverse outcomes also were essentially the same, except that the nonsuctioned neonates actually had significantly shorter durations of respiratory distress (19 vs. 43 hours) and mechanical ventilation (25 vs. 43 hours).

"In nonvigorous full-term neonates born to mothers with meconium-stained amniotic fluid, our study demonstrated that not performing endotracheal suction to clear the airway during neonatal resuscitation did not increase the incidence of meconium aspiration syndrome or predispose to death," Dr. Nangia commented.

Session attendee Dr. Martin Keszler of Brown University, Providence, R.I., said, "Congratulations for having the courage to do this important study. All of us have been wondering about it, but it’s a practice so deeply ingrained that at least in our litigious environment, it would be very difficult to do. ... I think that this is a very important study because it can reassure future investigators to get the courage up to do this very important work."

"Certainly, it was encouraging that [no endotracheal suctioning] was no worse than control. It even seems that it was better. ... I wonder if you could speculate ..., is the intervention truly harmful and are we really better off leaving them alone?" he asked.

"We really don’t have the numbers that are required to do kind of an equivalence study," Dr. Nangia replied. "So this is just the pilot where we have 175 babies."

Another attendee asked, "With these results, can you give us an idea of the sample size you need to prove [the findings] particularly in the babies with thick meconium? How many babies will you need to test the hypothesis?"

Given the incidence of meconium aspiration syndrome, "from a national perinatal database, we think we would require about 480 babies to study the difference," said Dr. Nangia.

Dr. Nangia disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The extent of stretching of the perineal body during the second stage of labor is not helpful in predicting which women will experience adverse obstetric and postpartum outcomes, new data show.

Short perineal body length is known to increase the risk of severe perineal laceration at the time of delivery as well as postpartum functional disorders, noted presenting author Dr. Jill Alldredge. Maternal expulsive efforts during the second stage of labor that stretch the pelvic floor may also damage the pelvic floor muscles.

She and her colleagues performed a planned secondary analysis of the APPLE cohort (Alterations in the Pelvic Floor in Pregnancy, Labor and Ensuing Years), analyzing data from 448 nulliparous women who had a vaginal birth attended by a certified nurse-midwife, had repeated perineal measurements over time, and were followed prospectively to 12 months post partum.

On average, perineal body length increased by about 2.4 cm in the cohort between the antepartum period and the maximal length during the second stage of labor, according to data reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

However, neither perineal body length nor change in this length at any time point was associated with perineal lacerations, or with urinary or anal incontinence or not being sexually active at 6 months post partum.

"We can see that the perineum is dynamic and does stretch during labor. However, measurement of the perineal body length and change in perineal body length between the antepartum, intrapartum, and post partum time periods does not predict perineal trauma or postpartum pelvic floor dysfunction," commented Dr. Alldredge, an obstetrics-gynecology resident at the University of New Mexico in Albuquerque.

APPLE participants had measurement of the perineal body length during the antepartum period, at the onset of labor, at the onset of and every 10 minutes during the second stage, and at 6 and 12 months post partum. The anal opening and the genital hiatus also were measured during the second stage of labor.

At 6 months, the women completed a set of questionnaires assessing pelvic floor function: the Incontinence Severity Index, the Wexner Fecal Incontinence Scale, and the Female Sexual Function Index.

The mean perineal body length was 3.7 cm during the antepartum period, and the mean maximal perineal body length during the second stage of labor was 6.1 cm, she said at the meeting, jointly sponsored by the American College of Surgeons.

During the second stage of labor, the maximal anal opening was 2.0 cm on average. The genital hiatus had an anterior-posterior maximal diameter of 7.5 cm, a maximal transverse diameter of 4.7 cm, and a maximal introital area of 119.4 cm².

Overall, 35% of women experienced a second-degree or worse perineal tear. And at 6 months post partum, 72% had at least mild urinary incontinence, 68% had at least mild anal incontinence, and 13% were not sexually active.

However, analyses showed that neither perineal body length nor stretch at any of the time points assessed was significantly associated with any of these outcomes.

Dr. Alldredge disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The extent of stretching of the perineal body during the second stage of labor is not helpful in predicting which women will experience adverse obstetric and postpartum outcomes, new data show.

Short perineal body length is known to increase the risk of severe perineal laceration at the time of delivery as well as postpartum functional disorders, noted presenting author Dr. Jill Alldredge. Maternal expulsive efforts during the second stage of labor that stretch the pelvic floor may also damage the pelvic floor muscles.

She and her colleagues performed a planned secondary analysis of the APPLE cohort (Alterations in the Pelvic Floor in Pregnancy, Labor and Ensuing Years), analyzing data from 448 nulliparous women who had a vaginal birth attended by a certified nurse-midwife, had repeated perineal measurements over time, and were followed prospectively to 12 months post partum.

On average, perineal body length increased by about 2.4 cm in the cohort between the antepartum period and the maximal length during the second stage of labor, according to data reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

However, neither perineal body length nor change in this length at any time point was associated with perineal lacerations, or with urinary or anal incontinence or not being sexually active at 6 months post partum.

"We can see that the perineum is dynamic and does stretch during labor. However, measurement of the perineal body length and change in perineal body length between the antepartum, intrapartum, and post partum time periods does not predict perineal trauma or postpartum pelvic floor dysfunction," commented Dr. Alldredge, an obstetrics-gynecology resident at the University of New Mexico in Albuquerque.

APPLE participants had measurement of the perineal body length during the antepartum period, at the onset of labor, at the onset of and every 10 minutes during the second stage, and at 6 and 12 months post partum. The anal opening and the genital hiatus also were measured during the second stage of labor.

At 6 months, the women completed a set of questionnaires assessing pelvic floor function: the Incontinence Severity Index, the Wexner Fecal Incontinence Scale, and the Female Sexual Function Index.

The mean perineal body length was 3.7 cm during the antepartum period, and the mean maximal perineal body length during the second stage of labor was 6.1 cm, she said at the meeting, jointly sponsored by the American College of Surgeons.

During the second stage of labor, the maximal anal opening was 2.0 cm on average. The genital hiatus had an anterior-posterior maximal diameter of 7.5 cm, a maximal transverse diameter of 4.7 cm, and a maximal introital area of 119.4 cm².

Overall, 35% of women experienced a second-degree or worse perineal tear. And at 6 months post partum, 72% had at least mild urinary incontinence, 68% had at least mild anal incontinence, and 13% were not sexually active.

However, analyses showed that neither perineal body length nor stretch at any of the time points assessed was significantly associated with any of these outcomes.

Dr. Alldredge disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The extent of stretching of the perineal body during the second stage of labor is not helpful in predicting which women will experience adverse obstetric and postpartum outcomes, new data show.

Short perineal body length is known to increase the risk of severe perineal laceration at the time of delivery as well as postpartum functional disorders, noted presenting author Dr. Jill Alldredge. Maternal expulsive efforts during the second stage of labor that stretch the pelvic floor may also damage the pelvic floor muscles.

She and her colleagues performed a planned secondary analysis of the APPLE cohort (Alterations in the Pelvic Floor in Pregnancy, Labor and Ensuing Years), analyzing data from 448 nulliparous women who had a vaginal birth attended by a certified nurse-midwife, had repeated perineal measurements over time, and were followed prospectively to 12 months post partum.

On average, perineal body length increased by about 2.4 cm in the cohort between the antepartum period and the maximal length during the second stage of labor, according to data reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

However, neither perineal body length nor change in this length at any time point was associated with perineal lacerations, or with urinary or anal incontinence or not being sexually active at 6 months post partum.

"We can see that the perineum is dynamic and does stretch during labor. However, measurement of the perineal body length and change in perineal body length between the antepartum, intrapartum, and post partum time periods does not predict perineal trauma or postpartum pelvic floor dysfunction," commented Dr. Alldredge, an obstetrics-gynecology resident at the University of New Mexico in Albuquerque.

APPLE participants had measurement of the perineal body length during the antepartum period, at the onset of labor, at the onset of and every 10 minutes during the second stage, and at 6 and 12 months post partum. The anal opening and the genital hiatus also were measured during the second stage of labor.

At 6 months, the women completed a set of questionnaires assessing pelvic floor function: the Incontinence Severity Index, the Wexner Fecal Incontinence Scale, and the Female Sexual Function Index.

The mean perineal body length was 3.7 cm during the antepartum period, and the mean maximal perineal body length during the second stage of labor was 6.1 cm, she said at the meeting, jointly sponsored by the American College of Surgeons.

During the second stage of labor, the maximal anal opening was 2.0 cm on average. The genital hiatus had an anterior-posterior maximal diameter of 7.5 cm, a maximal transverse diameter of 4.7 cm, and a maximal introital area of 119.4 cm².

Overall, 35% of women experienced a second-degree or worse perineal tear. And at 6 months post partum, 72% had at least mild urinary incontinence, 68% had at least mild anal incontinence, and 13% were not sexually active.

However, analyses showed that neither perineal body length nor stretch at any of the time points assessed was significantly associated with any of these outcomes.

Dr. Alldredge disclosed no relevant conflicts of interest.

VANCOUVER, B.C. – Motivational interviewing in the primary care setting promotes weight loss among overweight and obese children, according to results from a randomized trial reported at the annual meeting of the Pediatric Academic Societies.

Investigators conducted the trial, Brief Motivational Interviewing to Reduce Child Body Mass Index (BMi2), in 42 practices across the United States belonging to the Pediatric Research in Office Settings (PROS) research network.

Participants were 645 racially/ethnically and socioeconomically diverse children aged 2-8 years with a body mass index (BMI) in the 85th-97th percentile, and their parents.

©moodboard/thinkstockphotos.com

The practices were randomized into three even groups assigned to deliver usual care (assessment and health education materials), four sessions of motivational interviewing by pediatricians only, or four sessions by pediatricians plus six sessions by registered dietitians, generally by telephone.

Motivational interviewing entails rolling with patient/parent resistance to change, building a discrepancy between their current health status/behaviors and their values and goals, supporting their autonomy, and energizing them to change, explained lead author Ken Resnicow, Ph.D., professor of health behavior and health education, University of Michigan School of Public Health in Ann Arbor.

"When we train clinicians to do motivational interviewing, we want to move them from asking to reflecting, from counterpunching to rolling with resistance, and from informing and advising to eliciting autonomous change talk," he elaborated. If the technique is used properly, patients/parents should be talking more than half the time.

Main trial results showed that at the 2-year mark, all groups had a lower adjusted BMI percentile than the baseline average of about 92. However, the children who received motivational interviewing from both a pediatrician and dietitian had a significantly lower value than the children who received usual care (87.1 vs. 90.3) and a significantly greater reduction in that value from baseline (4.9 vs. 1.8). The findings were similar for raw BMI.

In addition, children in that intervention group consumed more servings of fruits and vegetables daily than their usual-care peers (4.3 vs. 3.8), and had fewer hours of screen time per day (2.2 vs. 2.5). Daily servings of sweet beverages and daily hours of physical activity did not differ significantly.

There were intermediate but generally nonsignificant benefits among the children who received motivational interviewing only from pediatricians.

Pediatricians were highly satisfied with their training, and parents were highly satisfied with pediatrician-delivered motivational interviewing.

"This is actually the first large-scale randomized controlled trial to show that motivational interviewing delivered by primary care providers significantly reduced BMI percentile and raw BMI, and with the effect size, I think most of our colleagues agree that these are clinically significant," Dr. Resnicow commented.

Pediatricians completed an average of 3.4 of their four planned motivational interviewing sessions, and dietitians completed 2.7 of their six planned sessions. Findings showed a dose-response whereby improvements in BMI were greater the more sessions a family completed.

"Of course, there are confounders here, and maybe families that are doing better are more likely to continue therapy, so we have to be careful not to infer causality. But it certainly suggests that our next couple of studies might want to focus on improving the dose of the motivational interviewing delivery," Dr. Resnicow commented. "We do feel that the dose of 4 and 10 sessions that we shot for is something that can be replicated in practice."

Attendee Dr. James M. Perrin, professor of pediatrics at Harvard Medical School, Boston, and president of the American Academy of Pediatrics, asked why results were better with motivational interviewing from both pediatricians and dietitians when the number of sessions delivered by dietitians was so low.

"I would just have to conclude that those additional three contacts, although only around 50% of what was prescribed, were still important. The dietitians did address different content, so it may be that the docs were very good at approaching the topics and setting goals, but the dietitians were able to get into more of the nutrition therapy, so even at that low dose, it seemed to add to what the docs were doing as sort of the background intervention," Dr. Resnicow speculated.

The pediatricians in the trial showed high competence and fidelity in their ability to deliver the motivational interviewing intervention, he noted. "They were handpicked in some ways; we had just an amazing group of pediatricians participating in the study. The next question is, can the average clinician do it – that’s a very important next step."

The investigators plan to disseminate the intervention more widely among PROS practices and to boost the dose of dietitian counseling through use of a disease management telephonic system, according to Dr. Resnicow.

Also, clinicians in the study were paid $50 per completed motivational interviewing session, but those in future studies will not be paid. "As long as fee-for-service is still around, they want to get reimbursed for this. ... For the two dissemination projects we are putting in..., we are going to help them maximize reimbursement, [using] 99214 and beyond," he said, referring to the CPT code for a visit by an established outpatient that includes moderate-complexity medical decision making.

Finally, the investigators plan to integrate the intervention with electronic health records to maximize its effectiveness. "Perhaps when the child comes in, many of you have electronic health record systems that may prompt you if you see an elevated BMI, but to take that one step further and have a motivational interviewing script pop up when you have a child who’s eligible for this type of counseling" should increase its use, he explained.

More information about motivational interviewing to address pediatric obesity is available online at the University of Michigan’s Center for Health Communications Research website, including DVDs about the project generally and about the intervention.

Dr. Resnicow had no relevant financial disclosures.

VANCOUVER, B.C. – Motivational interviewing in the primary care setting promotes weight loss among overweight and obese children, according to results from a randomized trial reported at the annual meeting of the Pediatric Academic Societies.

Investigators conducted the trial, Brief Motivational Interviewing to Reduce Child Body Mass Index (BMi2), in 42 practices across the United States belonging to the Pediatric Research in Office Settings (PROS) research network.

Participants were 645 racially/ethnically and socioeconomically diverse children aged 2-8 years with a body mass index (BMI) in the 85th-97th percentile, and their parents.

©moodboard/thinkstockphotos.com

The practices were randomized into three even groups assigned to deliver usual care (assessment and health education materials), four sessions of motivational interviewing by pediatricians only, or four sessions by pediatricians plus six sessions by registered dietitians, generally by telephone.

Motivational interviewing entails rolling with patient/parent resistance to change, building a discrepancy between their current health status/behaviors and their values and goals, supporting their autonomy, and energizing them to change, explained lead author Ken Resnicow, Ph.D., professor of health behavior and health education, University of Michigan School of Public Health in Ann Arbor.

"When we train clinicians to do motivational interviewing, we want to move them from asking to reflecting, from counterpunching to rolling with resistance, and from informing and advising to eliciting autonomous change talk," he elaborated. If the technique is used properly, patients/parents should be talking more than half the time.

Main trial results showed that at the 2-year mark, all groups had a lower adjusted BMI percentile than the baseline average of about 92. However, the children who received motivational interviewing from both a pediatrician and dietitian had a significantly lower value than the children who received usual care (87.1 vs. 90.3) and a significantly greater reduction in that value from baseline (4.9 vs. 1.8). The findings were similar for raw BMI.

In addition, children in that intervention group consumed more servings of fruits and vegetables daily than their usual-care peers (4.3 vs. 3.8), and had fewer hours of screen time per day (2.2 vs. 2.5). Daily servings of sweet beverages and daily hours of physical activity did not differ significantly.

There were intermediate but generally nonsignificant benefits among the children who received motivational interviewing only from pediatricians.

Pediatricians were highly satisfied with their training, and parents were highly satisfied with pediatrician-delivered motivational interviewing.

"This is actually the first large-scale randomized controlled trial to show that motivational interviewing delivered by primary care providers significantly reduced BMI percentile and raw BMI, and with the effect size, I think most of our colleagues agree that these are clinically significant," Dr. Resnicow commented.

Pediatricians completed an average of 3.4 of their four planned motivational interviewing sessions, and dietitians completed 2.7 of their six planned sessions. Findings showed a dose-response whereby improvements in BMI were greater the more sessions a family completed.

"Of course, there are confounders here, and maybe families that are doing better are more likely to continue therapy, so we have to be careful not to infer causality. But it certainly suggests that our next couple of studies might want to focus on improving the dose of the motivational interviewing delivery," Dr. Resnicow commented. "We do feel that the dose of 4 and 10 sessions that we shot for is something that can be replicated in practice."

Attendee Dr. James M. Perrin, professor of pediatrics at Harvard Medical School, Boston, and president of the American Academy of Pediatrics, asked why results were better with motivational interviewing from both pediatricians and dietitians when the number of sessions delivered by dietitians was so low.

"I would just have to conclude that those additional three contacts, although only around 50% of what was prescribed, were still important. The dietitians did address different content, so it may be that the docs were very good at approaching the topics and setting goals, but the dietitians were able to get into more of the nutrition therapy, so even at that low dose, it seemed to add to what the docs were doing as sort of the background intervention," Dr. Resnicow speculated.

The pediatricians in the trial showed high competence and fidelity in their ability to deliver the motivational interviewing intervention, he noted. "They were handpicked in some ways; we had just an amazing group of pediatricians participating in the study. The next question is, can the average clinician do it – that’s a very important next step."

The investigators plan to disseminate the intervention more widely among PROS practices and to boost the dose of dietitian counseling through use of a disease management telephonic system, according to Dr. Resnicow.

Also, clinicians in the study were paid $50 per completed motivational interviewing session, but those in future studies will not be paid. "As long as fee-for-service is still around, they want to get reimbursed for this. ... For the two dissemination projects we are putting in..., we are going to help them maximize reimbursement, [using] 99214 and beyond," he said, referring to the CPT code for a visit by an established outpatient that includes moderate-complexity medical decision making.

Finally, the investigators plan to integrate the intervention with electronic health records to maximize its effectiveness. "Perhaps when the child comes in, many of you have electronic health record systems that may prompt you if you see an elevated BMI, but to take that one step further and have a motivational interviewing script pop up when you have a child who’s eligible for this type of counseling" should increase its use, he explained.

More information about motivational interviewing to address pediatric obesity is available online at the University of Michigan’s Center for Health Communications Research website, including DVDs about the project generally and about the intervention.

Dr. Resnicow had no relevant financial disclosures.

VANCOUVER, B.C. – Motivational interviewing in the primary care setting promotes weight loss among overweight and obese children, according to results from a randomized trial reported at the annual meeting of the Pediatric Academic Societies.

Investigators conducted the trial, Brief Motivational Interviewing to Reduce Child Body Mass Index (BMi2), in 42 practices across the United States belonging to the Pediatric Research in Office Settings (PROS) research network.

Participants were 645 racially/ethnically and socioeconomically diverse children aged 2-8 years with a body mass index (BMI) in the 85th-97th percentile, and their parents.

©moodboard/thinkstockphotos.com

The practices were randomized into three even groups assigned to deliver usual care (assessment and health education materials), four sessions of motivational interviewing by pediatricians only, or four sessions by pediatricians plus six sessions by registered dietitians, generally by telephone.

Motivational interviewing entails rolling with patient/parent resistance to change, building a discrepancy between their current health status/behaviors and their values and goals, supporting their autonomy, and energizing them to change, explained lead author Ken Resnicow, Ph.D., professor of health behavior and health education, University of Michigan School of Public Health in Ann Arbor.

"When we train clinicians to do motivational interviewing, we want to move them from asking to reflecting, from counterpunching to rolling with resistance, and from informing and advising to eliciting autonomous change talk," he elaborated. If the technique is used properly, patients/parents should be talking more than half the time.

Main trial results showed that at the 2-year mark, all groups had a lower adjusted BMI percentile than the baseline average of about 92. However, the children who received motivational interviewing from both a pediatrician and dietitian had a significantly lower value than the children who received usual care (87.1 vs. 90.3) and a significantly greater reduction in that value from baseline (4.9 vs. 1.8). The findings were similar for raw BMI.

In addition, children in that intervention group consumed more servings of fruits and vegetables daily than their usual-care peers (4.3 vs. 3.8), and had fewer hours of screen time per day (2.2 vs. 2.5). Daily servings of sweet beverages and daily hours of physical activity did not differ significantly.

There were intermediate but generally nonsignificant benefits among the children who received motivational interviewing only from pediatricians.

Pediatricians were highly satisfied with their training, and parents were highly satisfied with pediatrician-delivered motivational interviewing.

"This is actually the first large-scale randomized controlled trial to show that motivational interviewing delivered by primary care providers significantly reduced BMI percentile and raw BMI, and with the effect size, I think most of our colleagues agree that these are clinically significant," Dr. Resnicow commented.

Pediatricians completed an average of 3.4 of their four planned motivational interviewing sessions, and dietitians completed 2.7 of their six planned sessions. Findings showed a dose-response whereby improvements in BMI were greater the more sessions a family completed.

"Of course, there are confounders here, and maybe families that are doing better are more likely to continue therapy, so we have to be careful not to infer causality. But it certainly suggests that our next couple of studies might want to focus on improving the dose of the motivational interviewing delivery," Dr. Resnicow commented. "We do feel that the dose of 4 and 10 sessions that we shot for is something that can be replicated in practice."

Attendee Dr. James M. Perrin, professor of pediatrics at Harvard Medical School, Boston, and president of the American Academy of Pediatrics, asked why results were better with motivational interviewing from both pediatricians and dietitians when the number of sessions delivered by dietitians was so low.

"I would just have to conclude that those additional three contacts, although only around 50% of what was prescribed, were still important. The dietitians did address different content, so it may be that the docs were very good at approaching the topics and setting goals, but the dietitians were able to get into more of the nutrition therapy, so even at that low dose, it seemed to add to what the docs were doing as sort of the background intervention," Dr. Resnicow speculated.

The pediatricians in the trial showed high competence and fidelity in their ability to deliver the motivational interviewing intervention, he noted. "They were handpicked in some ways; we had just an amazing group of pediatricians participating in the study. The next question is, can the average clinician do it – that’s a very important next step."

The investigators plan to disseminate the intervention more widely among PROS practices and to boost the dose of dietitian counseling through use of a disease management telephonic system, according to Dr. Resnicow.

Also, clinicians in the study were paid $50 per completed motivational interviewing session, but those in future studies will not be paid. "As long as fee-for-service is still around, they want to get reimbursed for this. ... For the two dissemination projects we are putting in..., we are going to help them maximize reimbursement, [using] 99214 and beyond," he said, referring to the CPT code for a visit by an established outpatient that includes moderate-complexity medical decision making.

Finally, the investigators plan to integrate the intervention with electronic health records to maximize its effectiveness. "Perhaps when the child comes in, many of you have electronic health record systems that may prompt you if you see an elevated BMI, but to take that one step further and have a motivational interviewing script pop up when you have a child who’s eligible for this type of counseling" should increase its use, he explained.

More information about motivational interviewing to address pediatric obesity is available online at the University of Michigan’s Center for Health Communications Research website, including DVDs about the project generally and about the intervention.

Dr. Resnicow had no relevant financial disclosures.

VANCOUVER, B.C. – Motivational interviewing in the primary care setting promotes weight loss among overweight and obese children, according to a randomized trial, which is the first of its kind. The study was reported at the annual meeting of the Pediatric Academic Societies.

Motivational interviewing is not new. It got its start in addiction medicine several decades ago, and only in the past decade has the technique made its way to chronic disease management. Lead author Ken Resnicow, Ph.D., professor of health behavior and health education, University of Michigan School of Public Health in Ann Arbor, explains the method and how it’s finding its place in pediatrics and primary care.

Vidyard Video

VANCOUVER, B.C. – Motivational interviewing in the primary care setting promotes weight loss among overweight and obese children, according to a randomized trial, which is the first of its kind. The study was reported at the annual meeting of the Pediatric Academic Societies.

Motivational interviewing is not new. It got its start in addiction medicine several decades ago, and only in the past decade has the technique made its way to chronic disease management. Lead author Ken Resnicow, Ph.D., professor of health behavior and health education, University of Michigan School of Public Health in Ann Arbor, explains the method and how it’s finding its place in pediatrics and primary care.

Vidyard Video

VANCOUVER, B.C. – Motivational interviewing in the primary care setting promotes weight loss among overweight and obese children, according to a randomized trial, which is the first of its kind. The study was reported at the annual meeting of the Pediatric Academic Societies.

Motivational interviewing is not new. It got its start in addiction medicine several decades ago, and only in the past decade has the technique made its way to chronic disease management. Lead author Ken Resnicow, Ph.D., professor of health behavior and health education, University of Michigan School of Public Health in Ann Arbor, explains the method and how it’s finding its place in pediatrics and primary care.

Vidyard Video