Evidence map›Paper›PMID 41554434›Full record

Trial reportThe Journal of pediatrics2026

Accelerated Weaning of Opioids to Reduce Pharmacologic Exposure for Neonatal Opioid Withdrawal Syndrome: A Randomized Clinical Trial.

Abbot R Laptook, Adam Czynski, Rouba Chahine, Rachel G Greenberg, P Brian Smith, Erica Oliveira, Jenna Gabrio, Barry Eggleston, Abhik Das, Jeannette Lee and 25 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in The Journal of pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04214834 (Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04214834 phase3active not recruitingnot on this map

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

TypeinterventionalSponsorAdvancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) ProgramRan2020 to 2026Enrolled189ConditionsNeonatal Opioid Withdrawal SyndromeArmsMorphine, Methadone
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

35 authors.

Abbot R LaptookWomen and Infants Hospital of Rhode Island, Brown University, Providence, RI. Electronic address: alaptook@wihri.org.
Adam CzynskiConnecticut Children's Medical Center, University of Connecticut, Hartford, CT.
Rouba ChahineSocial, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park, NC.
Rachel G GreenbergDuke Clinical Research Institute, Durham, NC.
P Brian SmithDuke Clinical Research Institute, Durham, NC.
Erica OliveiraWomen and Infants Hospital of Rhode Island, Brown University, Providence, RI.
Jenna GabrioSocial, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park, NC.
Barry EgglestonSocial, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park, NC.
Abhik DasSocial, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park, NC.
Jeannette LeeUniversity of Arkansas for Medical Sciences, Little Rock, AR.
Barry LesterBrown Center for Children at Risk, Brown University, Providence, RI.
Dave ClarkNational Institute of Child Health and Human Development, Bethesda, MD.
Michele WalshNational Institute of Child Health and Human Development, Bethesda, MD.
Helen KoUniversity of New Mexico Health Sciences Center, Albuquerque, NM.
Clare Campbell AsherUniversity of Arkansas for Medical Sciences, Little Rock, AR.
Hayley FriedmanWashington University School of Medicine, St Louis, MO.
Samuel GentleUniversity of Alabama at Birmingham, Birmingham, AL.
Karishma RaoChildren's Mercy Hospital, Kansas City, MO.
Anup KatheriaSharp Mary Birch, San Diego, CA.
Kristen BenningerNationwide Children's Hospital, Columbus, OH, Ohio State University, Wexner Medical Center, Columbus, OH.
Sanket JaniCentral Michigan University, Detroit, MI.
Mark Cody SmithWest Virginia University Hospital, Morgantown, WV.
Akram KhanSanford Health, Sioux Falls, SD.
Ajay TalatiUniversity of Tennessee Health Science Center, Memphis, TN.
Shaina LodhiLoma Linda University Medical Center, Loma Linda, CA.
Fernando MenaMedstar Franklin Square Medical Center, Baltimore, MD.
Amanda EnglandOchsner Baptist Clinical Trials Unit, New Orleans, LA.
Prabhu ParimiMetroHealth, Case Western Reserve University, Cleveland, OH.
Ranjit KylatUniversity of Arizona, Tucson, AZ.
Heidi HarmonUniversity of Iowa, Iowa City, IA.
Javed MannanUniversity of Massachusetts Memorial Medical Center, Worcester, MA.
Meghan P HowellTulane University School of Medicine, New Orleans, LA.
Tanner WrightUniversity of South Florida, Tampa, FL.
Jessica SnowdenUniversity of Tennessee Health Science Center, Memphis, TN.
ACT NOW Collaborative

Funding

NICHD Cooperative Multicenter Neonatal Research NetworkU10HD027904 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI LAPTOOK, ABBOT R · 1991 to 2015
$8.7M
NICHD Neonatal Research NetworkUG1HD027904 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI MARON, JILL LAMANNA · 2016 to 2024
$2.1M
Rhode Island Child Clinical Trials CollaborativeUG1HD090901 · NICHD · RHODE ISLAND HOSPITAL · PI CHUN, THOMAS H, DENNERY, PHYLLIS A. · 2016 to 2016
$172k
NICHD NIH HHS U10 HD027904NICHD NIH HHS UG1 HD027904NICHD NIH HHS UG1 HD090901
6 · The paper itself

Abstract

objectiveTo determine if newborns receiving morphine or methadone as the primary pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS) tolerate and receive fewer days of opioid using an accelerated wean protocol (15% decrements) compared with using a slower wean protocol (10% decrements). STUDY

designNewborns ≥36 weeks of gestation receiving morphine or methadone for NOWS were enrolled in a pragmatic blinded, randomized multicenter trial. Newborns underwent protocol-driven weaning with decreasing opioid doses of either 15% or 10% decrements. Weaning was encouraged every 24 hours, and if signs of NOWS worsened, the preceding dose was resumed. To maintain blinding, the last 3 dose levels of the 15% decrements were placebo. The primary outcome was the number of days of opioid treatment from the first weaning dose to cessation of opioids.

resultsSlow enrollment prompted early trial closure; 189 newborns were randomized, 98 (51.9%) to 15% decrements (mean ± SD, 38.8 ± 1.2 weeks gestation, 59.8% male) and 91 (48.1%) to 10% decrements (38.8 ± 1.3 weeks gestation, 61.5% male). Morphine was used most commonly. Intention-to-treat analysis included all but 4 infants withdrawn in the 15% decrement group. The durations of opioid treatment during weaning were 8.2 (7.2, 9.5) (adjusted mean [95% CI]) and 11.2 (9.7, 12.9) days for 15% and 10% decrement groups, respectively (P < .001). Adverse events were few in both groups.

conclusionPharmacologic treatment of NOWS using an accelerated wean protocol (15% decrements) was well tolerated with fewer days of opioid treatment compared with 10% decrements.

trial registrationClinicalTrials.gov number: NCT04214834.

Indexed as

Analgesics, OpioidMethadoneMorphineNeonatal Abstinence SyndromeFemaleHumansInfant, NewbornMaleAnalgesics, OpioidMethadoneMorphineabstinencemedication reductionmethadonemorphinenewborn

Identifiers

PMID41554434
PMCPMC12958472

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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.