Evidence map›Paper›PMID 37480087›Full record

Trial reportTrials2023

Pragmatic, randomized, blinded trial to shorten pharmacologic treatment of newborns with neonatal opioid withdrawal syndrome (NOWS).

Adam Czynski, Abbot Laptook, Abhik Das, Brian Smith, Alan Simon, Rachel Greenberg, Robert Annett, Jeannette Lee, Jessica Snowden, Claudia Pedroza and 4 more

Registry-linked trialOpen access · goldAbstract readPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2023. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.7field-weighted citation impact, top 14% 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.

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

6 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Review
  6. 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
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

14 authors at 8 institutions in 1 country.

Adam CzynskiConnecticut Children's Medical Center, Hartford, USA. aczynski@nychildrens.org.ORCID http://orcid.org/0000-0002-0062-0731
Abbot LaptookBrown University/Women & Infants Hospital of Rhode Island, Providence, USA.
Abhik DasRTI International, Research Triangle Park, USA.
Brian SmithDuke Clinical Research Institute, Durham, USA.
Alan SimonNational Institutes of Health, Bethesda, USA.
Rachel GreenbergDuke Clinical Research Institute, Durham, USA.
Robert AnnettUniversity of Mississippi, Oxford, USA.
Jeannette LeeUAMS, Little Rock, USA.
Jessica SnowdenUAMS, Little Rock, USA.
Claudia PedrozaUniversity of Texas, Houston, USA.
Barry LesterBrown University/Women & Infants Hospital of Rhode Island, Providence, USA.
Barry EgglestonRTI International, Research Triangle Park, USA.
Drew BremerNICHD NRN, Research Triangle Park, USA.
Elisabeth McGowanBrown University/Women & Infants Hospital of Rhode Island, Providence, USA.
Brown University · USClinical Research Institute · USRTI International · USConnecticut Children's Medical Center · USNational Institutes of Health · USTriangle · USUniversity of Houston · USUniversity of Mississippi · US

Funding

Project-005U2COD023375 · OD · DUKE UNIVERSITY · PI Phillip Brian Smith · 2016 to 2026
$215.9M
National institutes for health helping to end addiction long term initiative U24HD095254National institutes for health helping to end addiction long term initiative U24OD023957National institutes for health helping to end addiction long term initiative U2COD023375
6 · The paper itself

Abstract

backgroundThe incidence of maternal opioid use in the USA has increased substantially since 2000. As a consequence of opioid use during pregnancy, the incidence of neonatal opioid withdrawal syndrome (NOWS) has increased fivefold between 2002 and 2012. Pharmacological therapy is indicated when signs of NOWS cannot be controlled, and the objective of pharmacological therapy is to control NOWS signs. Once pharmacologic therapy has started, there is great variability in strategies to wean infants. An important rationale for studying weaning of pharmacological treatment for NOWS is that weaning represents the longest time interval of drug treatment. Stopping medications too early may not completely treat NOWS symptoms.

methodsThis will be a pragmatic, randomized, blinded trial of opioid weaning to determine whether more rapid weaning, compared to slow wean, will reduce the number of days of opioid treatment in infants receiving morphine or methadone as the primary treatment for NOWS. DISCUSSION: The proposed study is a pragmatic trial to determine whether a rapid-weaning intervention reduces the number of days of opioid treatment, compared to a slow-weaning intervention, and we powered the proposed study to detect a 2-day difference in the length of treatment. Hospitals will be able to use either morphine or methadone with the knowledge that we may find a positive treatment effect for both, one, or neither drugs.

trial registrationNCT04214834. Registered January 2, 2020.

Indexed as

Neonatal Abstinence SyndromeOpioid-Related DisordersAnalgesics, OpioidFamilyFemaleHumansInfant, NewbornMethadoneMorphinePregnancyResearch DesignAnalgesics, OpioidMethadoneMorphineBlindedMethadoneMorphineNeonatalNOWSOpioidPragmaticRandomizedWeaningWithdrawal

Identifiers

PMID37480087
PMCPMC10362592
OpenAlexW4385064569

What OpenQuestion holds

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LicenceCC BY
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.