Trial reportPediatrics2008
Sublingual buprenorphine for treatment of neonatal abstinence syndrome: a randomized trial.
Trial report in Pediatrics, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 37 papers, 5 of them syntheses that pooled 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.
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.
Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
A Randomized, Active-Control, Double-Blind, Double-Dummy Clinical Trial Comparing Sublingual Buprenorphine And Morphine Solution For The Treatment Of Neonatal Opioid Abstinence Syndrome
Who cites it
37 citing papers in PubMed, 5 syntheses or guidelines pooled it, 109 citations in OpenAlex.
- Opioid treatment for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021Pooled it
- Outcome reporting in neonates experiencing withdrawal following opioid exposure in pregnancy: a systematic review.Trials · 2020Pooled it
- Therapeutic approaches for neonatal abstinence syndrome: a systematic review of randomized clinical trials.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2019Pooled it
- Pharmacological Treatments for Neonatal Abstinence Syndrome: A Systematic Review and Network Meta-analysis.JAMA pediatrics · 2019Pooled it
- Review of the assessment and management of neonatal abstinence syndrome.Addiction science & clinical practice · 2014Pooled it
- Finding the right treatment for neonatal abstinence syndrome: is this the right time?Journal of perinatology : official journal of the California Perinatal Association · 2018Trial
- The Pharmacokinetics and Pharmacodynamics of Buprenorphine in Neonatal Abstinence Syndrome.Clinical pharmacology and therapeutics · 2018Trial
- Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome.The New England journal of medicine · 2017Trial
- Methadone versus morphine for treatment of neonatal abstinence syndrome: a prospective randomized clinical trial.Journal of perinatology : official journal of the California Perinatal Association · 2015Trial
- Revised dose schema of sublingual buprenorphine in the treatment of the neonatal opioid abstinence syndrome.Addiction (Abingdon, England) · 2011Trial
- Fentanyl exposure during preconception and gestation permanently dysregulates endogenous opioid peptides and sympathoadrenal-medullary axis in the offspring.Clinical science (London, England : 1979) · 2025Article
- 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 · 2025Article
- The Finnegan Score for Neonatal Opioid Withdrawal Revisited With Routine Electronic Data: Retrospective Study.JMIR pediatrics and parenting · 2024Article
- 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 · 2022Review
- Pharmacometric dose optimization of buprenorphine in neonatal opioid withdrawal syndrome.Clinical and translational science · 2021Article
- Identifying the Neurodevelopmental Differences of Opioid Withdrawal.Cellular and molecular neurobiology · 2021Article
- Clinical pharmacology and dosing regimen optimization of neonatal opioid withdrawal syndrome treatments.Clinical and translational science · 2021Review
- Using buprenorphine to treat neonatal abstinence syndrome: a quality improvement study.Journal of perinatology : official journal of the California Perinatal Association · 2021Article
- Neonatal Abstinence Syndrome Practices in the United States.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Article
- Pharmacological and non-pharmacological treatments for the Neonatal Abstinence Syndrome (NAS).Seminars in fetal & neonatal medicine · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveIn utero exposure to drugs of abuse can lead to neonatal abstinence syndrome, a condition that is associated with prolonged hospitalization. Buprenorphine is a partial mu-opioid agonist used for treatment of adult detoxification and maintenance but has never been administered to neonates with opioid abstinence syndrome. The primary objective of this study was to demonstrate the feasibility and, to the extent possible in this size of study, the safety of sublingual buprenorphine in the treatment of neonatal abstinence syndrome. Secondary goals were to evaluate efficacy relative to standard therapy and to characterize buprenorphine pharmacokinetics when sublingually administered.
methodsWe conducted a randomized, open-label, active-control study of sublingual buprenorphine for the treatment of opiate withdrawal. Thirteen term infants were allocated to receive sublingual buprenorphine 13.2 to 39.0 mug/kg per day administered in 3 divided doses and 13 to receive standard-of-care oral neonatal opium solution. Dose decisions were made by using a modified Finnegan scoring system.
resultsSublingual buprenorphine was largely effective in controlling neonatal abstinence syndrome. Greater than 98% of plasma concentrations ranged from undetectable to approximately 0.60 ng/mL, which is less than needed to control abstinence symptoms in adults. The ratio of buprenorphine to norbuprenorphine was larger than that seen in adults, suggesting a relative impairment of N-dealkylation. Three infants who received buprenorphine and 1 infant who received standard of care reached protocol-specified maximum doses and required adjuvant therapy with phenobarbital. The mean length of treatment for those in the neonatal-opium-solution group was 32 compared with 22 days for the buprenorphine group. The mean length of stay for the neonatal-opium-solution group was 38 days compared with 27 days for those in the buprenorphine group. Treatment with buprenorphine was well tolerated.
conclusionsBuprenorphine administered via the sublingual route is feasible and apparently safe and may represent a novel treatment for neonatal abstinence syndrome.
Indexed as
Identifiers
What OpenQuestion holds
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.