Buprenorphine cuts neonatal abstinence syndrome treatment length by nearly half
PAS Meeting Updates
SAN FRANCISCO – Findings of a phase 3 clinical trial being presented at the 2017 Pediatric
Academic Societies Meeting show that buprenorphine is just as safe and more effective
than morphine when used to treat newborns suffering withdrawal symptoms after prenatal
Researchers will present the study, “A Randomized Controlled Trial of Sublingual Buprenorphine
for the Treatment of the Neonatal Abstinence Syndrome,” on Sunday, May 7, at the Moscone
West Convention Center in San Francisco. The randomized controlled trial known as
B-BORN (Blinded Buprenorphine OR Neonatal morphine solution trial) will be published
online in the New England Journal of Medicine on May 4.
More than half of infants exposed to opioids during pregnancy require pharmacologic
treatment for withdrawal symptoms of neonatal abstinence syndrome, such as seizures
and respiratory and digestive problems, that make it difficult for them to adequately
eat and sleep. Traditional treatment for these newborns, most often with morphine,
requires lengthy hospital stays.
The B-BORN study followed up earlier-phase clinical trials that suggested buprenorphine
could reduce the length of treatment and hospitalization needed for babies with neonatal
abstinence syndrome. Researchers enrolled 63 infants who were born exposed to opioids
-- 97% of whom were exposed to methadone. They compared sublingual buprenorphine to
oral morphine treatment outcomes and found similarly promising results.
“This study has large public health implications, since the rate of neonatal abstinence
has increased almost 5-fold over the past 15 years,” said lead author Walter Kraft,
M.D., professor of pharmacology, medicine and surgery at Thomas Jefferson University.
In some hospitals, he said, NAS accounts for more than 20% of all days patients spend
in the neonatal intensive care unit.
Buprenorphine was associated with a 42% decrease in the length of treatment compared
to standard morphine, according to the trial. Average length of treatment needed for
babies given buprenorphine was 15 days compared with 28 days using morphine, he said,
while length of hospital stays for babies treated with buprenorphine averaged 21 days,
versus 34.5 days for those treated with morphine.
In addition, Dr. Kraft said, there were no readmissions or increased need for “rescue”
therapy with phenobarbital when symptoms didn’t initially subside. Buprenorphine has
a well-established safety record in adults, he said, and no safety issue was identified
in this trial. Babies’ respiratory rate, liver function and other health indicators,
for example, were similar in both groups.
“Our findings provide evidence that buprenorphine can safely and effectively serve
to reduce the significant burden of neonatal abstinence syndrome on individual infants
and families, and hospitals,” he said.
The Pediatric Academic Societies (PAS) Meeting brings together thousands of individuals
united by a common mission: to improve child health and well-being worldwide. This
international gathering includes pediatric researchers, leaders in academic pediatrics,
experts in child health, and practitioners. The PAS Meeting is produced through a
partnership of four organizations leading the advancement of pediatric research and
child advocacy: Academic Pediatric Association, American Academy of Pediatrics, American
Pediatric Society, and Society for Pediatric Research. For more information, visit
the PAS Meeting online at www.pas-meeting.org, follow us on Twitter @PASMeeting and
#pasm17, or like us on Facebook. For additional AAP News coverage, visit http://www.aappublications.org/collection/pas-meeting-updates