Buprenorphine reduces hospital stay, treatment time for neonatal abstinence syndrome
Infants with neonatal abstinence syndrome experienced shorter lengths of hospital treatments and stays when administered sublingual buprenorphine instead of standard morphine treatment, according to research presented at the 2017 Pediatric Academic Societies Meeting.
“At least half of infants with in utero opioid exposure will require pharmacologic treatment,” Walter Kraft, MD, professor of pharmacology, medicine and surgery at Thomas Jefferson University, told Infectious Diseases in Children. “In light of the dramatic reduction in length of treatment demonstrated in [this] trial, Thomas Jefferson University Hospital has begun the process of converting from the existing morphine protocol used in the trial to buprenorphine.”
To compare buprenorphine and morphine treatments for neonatal abstinence syndrome (NAS) regarding length of stay and treatment, researchers conducted a randomized phase 3 trial — the Blinded Buprenorphine OR Neonatal morphine solution trial (B-BORN) — of the sublingual medication among infants (n = 63) who had at least a gestational age of 37 weeks.
The researchers excluded children who had a major congenital anomaly, birth weight less than 2.2 kg, medical or neurologic illness, hypoglycemia requiring IV glucose, bilirubin above 20 g/dL, maternal benzodiazepine use less than 30 days before birth, or seizures.
The infants were scored with a modified Finnegan instrument, and those who had a single score of at least 12 or the total of three scores equaling at least 24 were randomly assigned to either a buprenorphine q8 or morphine q4 group. There was also a matched placebo group to maintain blinding of the study. Phenobarbital was added to the treatment regimens of infants whose symptoms continued at the maximum doses of opioid. All infants were weaned off opioid drugs in 10% intervals.
Among enrolled infants, 97% were exposed to methadone in utero. When analyzed infants — including “intention to treat,” “per protocol” and “as treated” populations — were administered buprenorphine, median length of treatment decreased significantly (15 vs. 28 days, P < .001).
Additionally, length of stay was reduced in all instances of buprenorphine use (21 vs. 34.5 days, P < .001). Comparable results were demonstrated regarding the necessity of adjunct phenobarbital in buprenorphine groups (5, 15%) and morphine groups (7, 23%). Compared with morphine, buprenorphine exhibited no additional safety issues and demonstrated similar effects on respiratory rate and liver function.
“Those at other hospitals looking to improve NAS treatment should focus not just on the ‘best’ drug for treatment, but instead implement a comprehensive approach of unified scoring, universal protocols and constant quality improvement,” Kraft told Infectious Diseases in Children. “To ensure the best outcomes for infants, we all need to maximize engagement with mothers and foster a nonjudgmental partnership.” —by Katherine Bortz.
Kraft W, et al. Abstract. Presented at: The Pediatric Academic Societies Meeting; May 6-9, 2017; San Francisco, CA.
Disclosure: The researchers report no relevant financial disclosures.