Evidence map›Paper›PMID 38815498›Full record

ArticleEarly human development2024

Neurobehavioral outcomes of infants exposed to buprenorphine-naloxone compared with naltrexone during pregnancy.

Saaz Mantri, An-Chiao Cheng, Kelley Saia, Hira Shrestha, Rachel Amgott, Jonathan Bressler, Martha M Werler, Ginny Carter, Hendree E Jones, Elisha M Wachman

Abstract readMulticenter StudyComparative Study
In one paragraph

Article in Early human development, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Hospital Care for Pregnant Persons With OUD Review.American journal of medicine open · 2025
    Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Saaz MantriBoston University Chobanian & Avedisian School of Medicine, 72 East Concord Street, Boston, MA, United States of America. Electronic address: saazym@bu.edu.
An-Chiao ChengDepartment of Pediatrics, Boston Medical Center, 670 Albany Street, Boston, MA 02118, United States of America. Electronic address: anchiao.cheng@bmc.org.
Kelley SaiaDepartment of Obstetrics & Gynecology, Boston Medical Center, One Boston Medical Center Place, Boston, MA 02118, United States of America. Electronic address: Kelley.Saia@bmc.org.
Hira ShresthaDepartment of Neurology, McCance Center for Brain Health, Massachusetts General Hospital, 399 Revolution Drive, Somerville, MA 02145, United States of America. Electronic address: Hshrestha@mgh.harvard.edu.
Rachel AmgottDepartment of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, United States of America. Electronic address: Rachel.Amgott@bmc.org.
Jonathan BresslerDepartment of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, United States of America. Electronic address: Jonathan.Bressler@bmc.org.
Martha M WerlerDepartment of Epidemiology, Boston University School of Public Health, 715 Albany Street, Boston, MA 02118, United States of America. Electronic address: werler@bu.edu.
Ginny CarterDepartment of Obstetrics & Gynecology, University of North Carolina, 410 N Greensboro St, Carrboro, NC 27510, United States of America. Electronic address: ginny_carter@med.unc.edu.
Hendree E JonesDepartment of Obstetrics & Gynecology, University of North Carolina, 410 N Greensboro St, Carrboro, NC 27510, United States of America. Electronic address: hendree_jones@med.unc.edu.
Elisha M WachmanDepartment of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, United States of America. Electronic address: Elisha.Wachman@bmc.org.

Funding

Safety, pharmacokinetics and efficacy of extended-release naltrexone in pregnant women with opioid use disorderR01HD096798 · NICHD · BOSTON MEDICAL CENTER · PI WACHMAN, ELISHA · 2018 to 2022
$3.4M
NICHD NIH HHS R01 HD096798
6 · The paper itself

Abstract

backgroundNaltrexone is a medication used to treat both opioid and alcohol use disorder with limited experience in pregnant individuals, particularly in comparison to more commonly utilized treatments such as buprenorphine-naloxone. The long-term outcomes of infants exposed to naltrexone has not been previously examined.

aimsTo compare the neurobehavioral outcomes of naltrexone versus buprenorphine-naloxone exposed infants. STUDY

designMulti-centered prospective cohort study. SUBJECTS: Pregnant people on prescribed buprenorphine-naloxone or naltrexone were enrolled during pregnancy and the dyad followed until 12 months after delivery. OUTCOME MEASURES: Infants were evaluated at 4-6 weeks corrected gestational age (CGA) using the NICU Neonatal Neurobehavioral Scale (NNNS) and at the 12-month CGA visit using the Ages and Stages Questionnaire, Third Edition (ASQ-3).

resultsThere were 7 dyads in the naltrexone group and 34 in the buprenorphine-naloxone group. On the NNNS, infants exposed to naltrexone had higher median scores for arousal and excitability, and lower median scores for attention and regulation at 4-6 weeks CGA compared to the buprenorphine-naloxone group. None of the infants in the naltrexone group were monitored for NOWS and had shorter length of hospital stay compared with the buprenorphine-naloxone group. Although no statistically significant differences were observed, more infants in the buprenorphine-naloxone group were identified as at risk for development delays in the communication, problem solving, and personal social domains of the ASQ-3 at 12 months CGA. Results should be interpreted with caution given this study's small sample size and lack of a prospective comparison cohort.

conclusionsIn this small cohort, there are differences noted in infant neurobehavior by NNNS at 4-6 weeks of age when comparing the buprenorphine-naloxone and naltrexone groups. At 12 months, ASQ-3 scores were similar but with percentage differences in potential development delay risk observed between the two groups. Larger cohort studies are needed to determine the long-term child outcomes after naltrexone exposure in pregnancy.

Indexed as

NaltrexoneNarcotic AntagonistsAdultBuprenorphineBuprenorphine, Naloxone Drug CombinationChild DevelopmentFemaleHumansInfantInfant BehaviorInfant, NewbornMaleNaloxoneOpioid-Related DisordersPregnancyPregnancy ComplicationsBuprenorphineBuprenorphine, Naloxone Drug CombinationNaloxoneNaltrexoneNarcotic AntagonistsASQ-3buprenorphine-naloxoneNaltrexoneNeurobehaviorNeurodevelopmentNNNS

Identifiers

PMID38815498
PMCPMC13264841

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Registered trials

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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.