TY - JOUR
KW - Administration, Oral
KW - Administration, Sublingual
KW - Analgesics, Opioid/adverse effects/therapeutic use
KW - Buprenorphine/adverse effects/therapeutic use
KW - Double-Blind Method
KW - Drug Therapy, Combination
KW - Female
KW - Humans
KW - Hypnotics and Sedatives/therapeutic use
KW - Infant, Newborn
KW - Length of Stay
KW - Male
KW - Morphine/adverse effects/therapeutic use
KW - Neonatal Abstinence Syndrome/drug therapy
KW - Opiate Substitution Treatment
KW - Phenobarbital/therapeutic use
AU - W. K. Kraft
AU - S. C. Adeniyi-Jones
AU - I. Chervoneva
AU - J. S. Greenspan
AU - D. Abatemarco
AU - K. Kaltenbach
AU - M. E. Ehrlich
A1 - 
AB - BACKGROUND: Current pharmacologic treatment of the neonatal abstinence syndrome with morphine is associated with a lengthy duration of therapy and hospitalization. Buprenorphine may be more effective than morphine for this indication. METHODS: In this single-site, double-blind, double-dummy clinical trial, we randomly assigned 63 term infants (>/=37 weeks of gestation) who had been exposed to opioids in utero and who had signs of the neonatal abstinence syndrome to receive either sublingual buprenorphine or oral morphine. Infants with symptoms that were not controlled with the maximum dose of opioid were treated with adjunctive phenobarbital. The primary end point was the duration of treatment for symptoms of neonatal opioid withdrawal. Secondary clinical end points were the length of hospital stay, the percentage of infants who required supplemental treatment with phenobarbital, and safety. RESULTS: The median duration of treatment was significantly shorter with buprenorphine than with morphine (15 days vs. 28 days), as was the median length of hospital stay (21 days vs. 33 days) (P<0.001 for both comparisons). Adjunctive phenobarbital was administered in 5 of 33 infants (15%) in the buprenorphine group and in 7 of 30 infants (23%) in the morphine group (P=0.36). Rates of adverse events were similar in the two groups. CONCLUSIONS: Among infants with the neonatal abstinence syndrome, treatment with sublingual buprenorphine resulted in a shorter duration of treatment and shorter length of hospital stay than treatment with oral morphine, with similar rates of adverse events. (Funded by the National Institute on Drug Abuse; BBORN ClinicalTrials.gov number, NCT01452789 .).
BT - The New England Journal of Medicine
C5 - Opioids & Substance Use
CP - 24
CY - United States
DO - 10.1056/NEJMoa1614835
IS - 24
JF - The New England Journal of Medicine
N2 - BACKGROUND: Current pharmacologic treatment of the neonatal abstinence syndrome with morphine is associated with a lengthy duration of therapy and hospitalization. Buprenorphine may be more effective than morphine for this indication. METHODS: In this single-site, double-blind, double-dummy clinical trial, we randomly assigned 63 term infants (>/=37 weeks of gestation) who had been exposed to opioids in utero and who had signs of the neonatal abstinence syndrome to receive either sublingual buprenorphine or oral morphine. Infants with symptoms that were not controlled with the maximum dose of opioid were treated with adjunctive phenobarbital. The primary end point was the duration of treatment for symptoms of neonatal opioid withdrawal. Secondary clinical end points were the length of hospital stay, the percentage of infants who required supplemental treatment with phenobarbital, and safety. RESULTS: The median duration of treatment was significantly shorter with buprenorphine than with morphine (15 days vs. 28 days), as was the median length of hospital stay (21 days vs. 33 days) (P<0.001 for both comparisons). Adjunctive phenobarbital was administered in 5 of 33 infants (15%) in the buprenorphine group and in 7 of 30 infants (23%) in the morphine group (P=0.36). Rates of adverse events were similar in the two groups. CONCLUSIONS: Among infants with the neonatal abstinence syndrome, treatment with sublingual buprenorphine resulted in a shorter duration of treatment and shorter length of hospital stay than treatment with oral morphine, with similar rates of adverse events. (Funded by the National Institute on Drug Abuse; BBORN ClinicalTrials.gov number, NCT01452789 .).
PP - United States
PY - 2017
SN - 1533-4406; 0028-4793
SP - 2341
EP - 2348
EP - 
T1 - Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome
T2 - The New England Journal of Medicine
TI - Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome
U1 - Opioids & Substance Use
U2 - 28468518
U3 - 10.1056/NEJMoa1614835
VL - 376
VO - 1533-4406; 0028-4793
Y1 - 2017
ER -