Nav: Home

Buprenorphine cuts neonatal abstinence syndrome treatment length by nearly half

May 04, 2017

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 drug exposure.

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 percent 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, MD, Professor of Pharmacology, Medicine & Surgery at Thomas Jefferson University. In some hospitals, he said, NAS accounts for more than 20 percent of all days patients spend in the neonatal intensive care unit.

Buprenorphine was associated with a 42 percent 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.

Dr. Kraft will present the study, "A Randomized Controlled Trial of Sublingual Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome," at 8:45 a.m. Sunday May 7,
-end-
The Pediatric Academic Societies (PAS) Meeting brings together thousands of individuals united by a common mission: to improve child health and wellbeing 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 http://www.pas-meeting.org, follow us on Twitter @PASMeeting and #pasm17, or like us on Facebook.

ABSTRACT

TITLE: A Randomized Controlled Trial of Sublingual Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome

Background: Pharmacologic treatment of neonatal opioid abstinence syndrome (NAS) with morphine (MOR) is associated with a long duration of treatment and hospital stay. Phase 1 clinical data suggest that buprenorphine (BUP), a partial mu opioid agonist, may be more effective than MOR for the treatment of NAS.

Objective: This is a Phase 3 clinical trial comparing sublingual BUP to oral MOR as treatment for NAS. The primary outcome was length of treatment (LOT), and secondary outcomes were length of hospitalization (LOS), and need for adjunct therapy with phenobarbital. Design/Methods: This was a double blind, double dummy, single site, randomized, clinical trial (NCT01452789). Opioid exposed infants ≥ 37 wks GA were eligible. Exclusion criteria were: major congenital anomaly, birth wt < 2.2 Kg, medical or neurologic illness, hypoglycemia requiring IV glucose, bilirubin > 20 g/dl, maternal benzodiazepine use < 30 days before birth, or seizures. Infants were scored using a modified Finnegan instrument. Infants with a single score ≥ 12 or sum of 3 scores ≥ 24 were randomized to receive BUP q8 or MOR q4, and a matched placebo to maintain blinding. If NAS symptoms persisted at maximum doses of opioid, phenobarbital was added. Doses were weaned in 10% steps. The two-sample Wilcoxon rank sum test with continuity correction was used to compare LOT and LOS. Supplemental phenobarbital requirement was compared using Fisher's exact test.

Results: Sixty-three infants were enrolled (BUP = 33, MOR = 30). 97% of infants had in utero exposure to methadone. Patients were analyzed according to intention to treat, per protocol, and as treated populations. In all analyses, BUP significantly reduced median LOT (15 vs. 28 days, P<0.001) and LOS (21 vs 34.5 days, P<0.001) when compared to MOR. There was no difference (p =0.53) of need for adjunct phenobarbital between BUP (5, 15%) and MOR (7, 23%). Safety measures, including respiratory rate and liver function, were comparable in both groups.

Conclusion(s): In the treatment of NAS, sublingual BUP is associated with shorter LOT and LOS than current standard of care using oral MOR. BUP was as safe as MOR and offers an alternative to treating NAS.

American Academy of Pediatrics

Related Infants Articles:

Probiotic may help treat colic in infants
Probiotics -- or 'good bacteria' -- have been used to treat infant colic with varying success.
Deaf infants' gaze behavior more advanced than that of hearing infants
Deaf infants who have been exposed to American Sign Language are better at following an adult's gaze than their hearing peers, supporting the idea that social-cognitive development is sensitive to different kinds of life experiences.
Initiating breastfeeding in vulnerable infants
The benefits of breastfeeding for both mother and child are well-recognized, including for late preterm infants (LPI).
Young infants with fever may be more likely to develop infections
Infants with a high fever may be at increased risk for infections, according to research from Penn State College of Medicine.
Early term infants less likely to breastfeed
A new, prospective study provides evidence that 'early term' infants (those born at 37-38 weeks) are less likely than full-term infants to be breastfeed within the first hour and at one month after birth.
Infants are more likely to learn when with a peer
Researchers at the University of Connecticut and University of Washington looked at the mechanisms involved in language learning among nine-month-olds, the youngest population known to be studied in relation to on-screen learning.
Allergic reactions to foods are milder in infants
Majority of infants with food-induced anaphylaxis present with hives and vomiting, suggesting there is less concern for life-threatening response to early food introduction.
Non-dairy drinks can be dangerous for infants
A brief report published in Acta Paediatrica points to the dangers of replacing breast milk or infant formula with a non-dairy drink before one year of age.
Infants can't talk, but they know how to reason
A new study reveals that preverbal infants are able to make rational deductions, showing surprise when an outcome does not occur as expected.
Infants are able to learn abstract rules visually
Three-month-old babies cannot sit up or roll over, yet they are already capable of learning patterns from simply looking at the world around them, according to a recent Northwestern University study published in PLOS One.
More Infants News and Infants Current Events

Top Science Podcasts

We have hand picked the top science podcasts of 2019.
Now Playing: TED Radio Hour

In & Out Of Love
We think of love as a mysterious, unknowable force. Something that happens to us. But what if we could control it? This hour, TED speakers on whether we can decide to fall in — and out of — love. Guests include writer Mandy Len Catron, biological anthropologist Helen Fisher, musician Dessa, One Love CEO Katie Hood, and psychologist Guy Winch.
Now Playing: Science for the People

#543 Give a Nerd a Gift
Yup, you guessed it... it's Science for the People's annual holiday episode that helps you figure out what sciency books and gifts to get that special nerd on your list. Or maybe you're looking to build up your reading list for the holiday break and a geeky Christmas sweater to wear to an upcoming party. Returning are pop-science power-readers John Dupuis and Joanne Manaster to dish on the best science books they read this past year. And Rachelle Saunders and Bethany Brookshire squee in delight over some truly delightful science-themed non-book objects for those whose bookshelves are already full. Since...
Now Playing: Radiolab

An Announcement from Radiolab