Evidence map›Paper›PMID 36030327›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2023

Ondansetron to reduce neonatal opioid withdrawal severity a randomized clinical trial.

Gary Peltz, Lauren M Jansson, Susan Adeniyi-Jones, Carol Cohane, David Drover, Steven Shafer, Meiyue Wang, Manhong Wu, Balaji Govindaswami, Priya Jegatheesan and 3 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01965704 (AIM 2- Prevention of Neonatal Abstinence Syndrome), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.4field-weighted citation impact, top 21% 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.

NCT01965704 phase2completednot on this map

AIM 2- Prevention of Neonatal Abstinence Syndrome

TypeinterventionalSponsorStanford UniversityRan2014 to 2020Enrolled196ConditionsNarcotic Addiction, Neonatal Abstinence SyndromeArmsOndansetron, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

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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

13 authors at 4 institutions in 1 country.

Gary PeltzDepartment of Anesthesiology, Pain and Perioperative Medicine, Stanford University School of Medicine, Stanford, CA, USA. gpeltz@stanford.edu.ORCID http://orcid.org/0000-0001-6191-7697
Lauren M JanssonDepartment of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0003-2708-6142
Susan Adeniyi-JonesDepartment of Pediatrics Nemours Neonatology at Jefferson, Thomas Jefferson University, Philadelphia, PA, USA.ORCID http://orcid.org/0000-0003-4518-1709
Carol CohaneDepartment of Anesthesiology, Pain and Perioperative Medicine, Stanford University School of Medicine, Stanford, CA, USA.ORCID http://orcid.org/0000-0003-4363-5260
David DroverDepartment of Anesthesiology, Pain and Perioperative Medicine, Stanford University School of Medicine, Stanford, CA, USA.ORCID http://orcid.org/0000-0001-6633-3295
Steven ShaferDepartment of Anesthesiology, Pain and Perioperative Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Meiyue WangDepartment of Anesthesiology, Pain and Perioperative Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Manhong WuDepartment of Anesthesiology, Pain and Perioperative Medicine, Stanford University School of Medicine, Stanford, CA, USA.ORCID http://orcid.org/0000-0001-5491-3081
Balaji GovindaswamiDepartment of Pediatrics, Santa Clara Valley Medical Center, San Jose, CA, USA.
Priya JegatheesanDepartment of Pediatrics, Santa Clara Valley Medical Center, San Jose, CA, USA.ORCID http://orcid.org/0000-0003-4068-0330
Cynthia ArganiDepartment of Obstetrics and Gynecology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Salwa KhanDivision of Hospital Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Walter K KraftDepartment of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA, USA.ORCID http://orcid.org/0000-0002-5074-0141
Stanford Medicine · USJohns Hopkins University · USSanta Clara Valley Medical Center · USThomas Jefferson University · US

Funding

Prevention of neonatal opioid withdrawal syndromeR01HD070795 · NICHD · STANFORD UNIVERSITY · PI PELTZ, GARY A · 2012 to 2020
$6.1M
NICHD NIH HHS R01 HD070795NIDA NIH HHS 5U01DA04439902NIH HHS 5RO1HD070795-06A1
6 · The paper itself

Abstract

objectiveTo determine if treatment with a 5-HT3 antagonist (ondansetron) reduces need for opioid therapy in infants at risk for neonatal opioid withdrawal syndrome (NOWS). STUDY

designA multicenter, randomized, placebo controlled, double blind clinical trial of ninety (90) infants. The intervention arms were intravenous ondansetron or placebo during labor followed by a daily dose of ondansetron or placebo in infants for five days.

resultsTwenty-two (49%) ondansetron-treated and 26 (63%) placebo-treated infants required pharmacologic treatment (p > 0.05). The Finnegan score was lower in the ondansetron-treated group (4.6 vs. 5.6, p = 0.02). A non-significant trend was noted for the duration of hospitalization. There was no difference in need for phenobarbital or clonidine therapy, or total dose of morphine in the first 15 days of NOWS treatment.

conclusionsOndansetron treatment reduced the severity of NOWS symptoms; and there was an indication that it could reduce the length of stay. CLINICAL

trial registrationClinicaltrials.gov NCT01965704.

Indexed as

Analgesics, OpioidNeonatal Abstinence SyndromeHumansInfant, NewbornMorphineOndansetronPhenobarbitalAnalgesics, OpioidMorphineOndansetronPhenobarbital

Identifiers

PMID36030327
PMCPMC9968817
OpenAlexW4293325312

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.