Evidence map›Paper›PMID 28468518›Full record

Trial reportThe New England journal of medicine2017

Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome.

Walter K Kraft, Susan C Adeniyi-Jones, Inna Chervoneva, Jay S Greenspan, Diane Abatemarco, Karol Kaltenbach, Michelle E Ehrlich

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01452789 (A Randomized, Active-Control, Double-Blind, Double-Dummy Clinical Trial Comparing Sublingual Buprenorphine And Morphine Solution For The Treatment Of Neonatal Opioid Abstinence Syndrome), which is not on this map. Cited by 67 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 6 pooled it
36.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01452789 phase3completednot on this map

A Randomized, Active-Control, Double-Blind, Double-Dummy Clinical Trial Comparing Sublingual Buprenorphine And Morphine Solution For The Treatment Of Neonatal Opioid Abstinence Syndrome

TypeinterventionalSponsorThomas Jefferson UniversityRan2011 to 2016Enrolled63ConditionsNeonatal Abstinence SyndromeArmssublingual buprenorphine, oral morphine
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 6 syntheses or guidelines pooled it, 163 citations in OpenAlex.

  1. Pooled it
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  3. Opioid treatment for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021
    Pooled it
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  5. Therapeutic approaches for neonatal abstinence syndrome: a systematic review of randomized clinical trials.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2019
    Pooled it
  6. Pooled it
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  13. Article
  14. Stability Study of Compounded Ethanol-Free Buprenorphine Oral Syringes for the Treatment of Neonatal Opioid Withdrawal Syndrome.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026
    Article
  15. Article
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  18. Buprenorphine vs. morphine: impact on neonatal opioid withdrawal syndrome (NOWS) outcomes in a single center retrospective study.Journal of perinatology : official journal of the California Perinatal Association · 2025
    Article
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  20. Article

7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Walter K KraftFrom Sidney Kimmel Medical College, Thomas Jefferson University (W.K.K., S.C.A.-J., I.C., J.S.G., D.A., K.K.), and Nemours duPont Pediatrics, Thomas Jefferson University Hospital (S.C.A.-J., J.S.G.) - both in Philadelphia; and the Departments of Neurology, Pediatrics, and Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.E.E.).
Susan C Adeniyi-JonesFrom Sidney Kimmel Medical College, Thomas Jefferson University (W.K.K., S.C.A.-J., I.C., J.S.G., D.A., K.K.), and Nemours duPont Pediatrics, Thomas Jefferson University Hospital (S.C.A.-J., J.S.G.) - both in Philadelphia; and the Departments of Neurology, Pediatrics, and Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.E.E.).
Inna ChervonevaFrom Sidney Kimmel Medical College, Thomas Jefferson University (W.K.K., S.C.A.-J., I.C., J.S.G., D.A., K.K.), and Nemours duPont Pediatrics, Thomas Jefferson University Hospital (S.C.A.-J., J.S.G.) - both in Philadelphia; and the Departments of Neurology, Pediatrics, and Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.E.E.).
Jay S GreenspanFrom Sidney Kimmel Medical College, Thomas Jefferson University (W.K.K., S.C.A.-J., I.C., J.S.G., D.A., K.K.), and Nemours duPont Pediatrics, Thomas Jefferson University Hospital (S.C.A.-J., J.S.G.) - both in Philadelphia; and the Departments of Neurology, Pediatrics, and Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.E.E.).
Diane AbatemarcoFrom Sidney Kimmel Medical College, Thomas Jefferson University (W.K.K., S.C.A.-J., I.C., J.S.G., D.A., K.K.), and Nemours duPont Pediatrics, Thomas Jefferson University Hospital (S.C.A.-J., J.S.G.) - both in Philadelphia; and the Departments of Neurology, Pediatrics, and Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.E.E.).
Karol KaltenbachFrom Sidney Kimmel Medical College, Thomas Jefferson University (W.K.K., S.C.A.-J., I.C., J.S.G., D.A., K.K.), and Nemours duPont Pediatrics, Thomas Jefferson University Hospital (S.C.A.-J., J.S.G.) - both in Philadelphia; and the Departments of Neurology, Pediatrics, and Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.E.E.).
Michelle E EhrlichFrom Sidney Kimmel Medical College, Thomas Jefferson University (W.K.K., S.C.A.-J., I.C., J.S.G., D.A., K.K.), and Nemours duPont Pediatrics, Thomas Jefferson University Hospital (S.C.A.-J., J.S.G.) - both in Philadelphia; and the Departments of Neurology, Pediatrics, and Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.E.E.).
Thomas Jefferson University · USThomas Jefferson University Hospital · USPediatrics and Genetics · US

Funding

A Comparison of Buprenorphine Versus Morphine in the Treatment of the Neonatal AbR01DA029076 · NIDA · THOMAS JEFFERSON UNIVERSITY · PI KRAFT, WALTER K · 2011 to 2016
$2.4M
DRUG ABUSE, STRESS, AND ADAPTATION IN OLD PEOPLER01DA002976 · NIDA · UNIVERSITY OF CALIFORNIA BERKELEY · PI LAZARUS, RICHARD S · 1985 to 1985
–
NIDA NIH HHS R01 DA029076NIDA NIH HHS R01DA02976
6 · The paper itself

Abstract

backgroundCurrent 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.

methodsIn 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.

resultsThe 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.

conclusionsAmong 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 .).

Indexed as

Opiate Substitution TreatmentAdministration, OralAdministration, SublingualAnalgesics, OpioidBuprenorphineDouble-Blind MethodDrug Therapy, CombinationFemaleHumansHypnotics and SedativesInfant, NewbornLength of StayMaleMorphineNeonatal Abstinence SyndromePhenobarbitalAnalgesics, OpioidBuprenorphineHypnotics and SedativesMorphinePhenobarbital

Identifiers

PMID28468518
PMCPMC5662132
OpenAlexW2610226880

What OpenQuestion holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.