Evidence map›Paper›PMID 20925688›Full record

Trial reportAddiction (Abingdon, England)2011

Revised dose schema of sublingual buprenorphine in the treatment of the neonatal opioid abstinence syndrome.

Walter K Kraft, Kevin Dysart, Jay S Greenspan, Eric Gibson, Karol Kaltenbach, Michelle E Ehrlich

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 39 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 5 pooled it
9.3field-weighted citation impact, top 2% 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.

NCT00521248 phase1completednot on this map

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

TypeinterventionalSponsorThomas Jefferson UniversityRan2004 to 2010Enrolled60ConditionsNeonatal Abstinence SyndromeArmsbuprenorphine, Oral morphine solution
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
NCT04455802 phase3withdrawnnot on this mapstarted 2020, after this paper: background citation

Prospective Randomized Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

TypeinterventionalSponsorWomen and Infants Hospital of Rhode IslandRan2020 to 2021Enrolled0ConditionsNeonatal Opioid Withdrawal SyndromeArmsBuprenorphine or Placebo, Morphine or Placebo
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 5 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Opioid treatment for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Pooled it
  3. 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
  4. Pooled it
  5. Pooled it
  6. Finding the right treatment for neonatal abstinence syndrome: is this the right time?Journal of perinatology : official journal of the California Perinatal Association · 2018
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. 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
  12. Review
  13. Neonatal opioid withdrawal syndrome: a review of the science and a look toward the use of buprenorphine for affected infants.Journal of perinatology : official journal of the California Perinatal Association · 2022
    Review
  14. Article
  15. Review
  16. Using buprenorphine to treat neonatal abstinence syndrome: a quality improvement study.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  17. Article
  18. Article
  19. Review
  20. Buprenorphine for the Treatment of Neonatal Abstinence Syndrome.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2018
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Walter K KraftDepartment of Pharmacology and Experimental Therapeutics Pediatrics, Jefferson Medical College, Philadelphia, PA, USA. walter.kraft@jefferson.edu
Kevin Dysart
Jay S Greenspan
Eric Gibson
Karol Kaltenbach
Michelle E Ehrlich
Jefferson College · USCommunity Health Systems - Dupont Hospital · USDuPont (United States) · USIcahn School of Medicine at Mount Sinai · US

Funding

Buprenorphine Treatment of Neonatal Abstinence SyndromeR21DA018207 · NIDA · THOMAS JEFFERSON UNIVERSITY · PI KRAFT, WALTER K. · 2005 to 2006
$390k
NIDA NIH HHS R21 DA018207NIDA NIH HHS R21DA018207
6 · The paper itself

Abstract

aimsMore than half of infants exposed to opioids in utero develop neonatal abstinence syndrome (NAS) of severity to require pharmacological therapy. Current treatments are associated with prolonged hospitalization. We sought to optimize the dose of sublingual buprenorphine in the treatment of NAS.

designRandomized, Phase 1, open-label, active-control clinical trial comparing sublingual buprenorphine to oral morphine.

settingLarge, urban, tertiary care hospital.

participantsTwenty-four term infants requiring pharmacological treatment for NAS. MEASUREMENTS: Outcomes were neonatal safety, length of treatment and length of hospitalization.

findingsSublingual buprenorphine was safe and effective. Infants treated with buprenorphine had a 23-day length of treatment compared to 38 days for those treated with morphine (P = 0.01), representing a 40% reduction. Length of hospital stay in the buprenorphine group was reduced 24%, from 42 to 32 days (P = 0.05).

conclusionsSublingual buprenorphine was safe in NAS, with a substantial efficacy advantage over standard of care therapy with oral morphine.

Indexed as

Administration, SublingualAdultBirth WeightBuprenorphineCytomegalovirus InfectionsDose-Response Relationship, DrugFemaleHumansHypnotics and SedativesInfant, NewbornLength of StayMaleMorphineNarcotic AntagonistsNeonatal Abstinence SyndromeOpiate Substitution TreatmentBuprenorphineHypnotics and SedativesMorphineNarcotic AntagonistsPhenobarbital

Identifiers

PMID20925688
PMCPMC3022999
OpenAlexW1928789054

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.