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Which drug helps Opioid-Affected newborns go home sooner?

NCT ID NCT07278375

Knowledge-focused Sponsor: HELP for NOWS Consortium Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at medical records of about 800 full-term newborns with Neonatal Opioid Withdrawal Syndrome (NOWS) to compare two standard treatments: buprenorphine and morphine. Researchers want to find out which medicine helps babies recover and become ready for discharge sooner. No new treatments or procedures are given—only existing data is reviewed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 796 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include infant and mother dyads who fulfill the study inclusion and exclusion criteria.

Ages

0 minutes and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Infant is ≥ 36 weeks' gestational age 2. Infant had antenatal opioid exposure identified by at least one of the following: 1. History of maternal opioid use during the second and/or third trimester of pregnancy as noted in the mother's or infant's medical record; 2. Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or 3. Positive infant toxicology screen for opioids during the initial hospital stay. 3. The infant is being assessed and managed for NOWS at an eligible study site. 4. The infant is at risk for pharmacologic treatment for NOWS defined by either of the following: * At least 1 score ≥ 8 if assessed and managed with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) or modification thereof * At least 1 "yes" if assessed and managed with the Eat, Sleep, Console (ESC) care approach 5. Infant met all inclusion criteria on or after March 25, 2024. Exclusion Criteria: 1. Infant has major congenital anomalies. 2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment. 3. Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age. 4. Infant has undergone major surgical intervention prior to or at 48 hours of age. 5. Infant has postnatal opioid exposure prior to the initiation of pharmacologic treatment for NOWS. 6. Infant was outborn and pharmacologic treatment was initiated at the transferring hospital.

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neonatal opioid withdrawal syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Regional Hospital, Cooper University Health Care

    NOT_YET_RECRUITING

    Camden, New Jersey, 08103, United States

  • ChristianaCare

    NOT_YET_RECRUITING

    Wilmington, Delaware, 19801, United States

  • Cincinnati Children's Hospital Medical Center

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Good Samaritan Hospital

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45202, United States

  • Kentucky Children's Hospital

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • Norton Children's Hospital

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40202, United States

  • Norton Women's and Children's Hospital

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40207, United States

  • Pennsylvania Hospital

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Rainbow Babies and Children's Hospital

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • Riley Hospital for Children at IU Health

    RECRUITING

    Indianapolis, Indiana, 46202-5119, United States

  • Sidney & Lois Eskenazi Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • St. Elizabeth Healthcare

    NOT_YET_RECRUITING

    Edgewood, Kentucky, 41017, United States

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205-7199, United States

  • University of Louisville Hospital

    NOT_YET_RECRUITING

    Jeffersonville, Indiana, 47130, United States

  • University of New Mexico Health Sciences Center

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of Rochester Medical Center

    NOT_YET_RECRUITING

    Rochester, New York, 14642, United States

  • University of South Florida Health

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Utah Health

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84158, United States

  • University of Vermont Medical Center

    NOT_YET_RECRUITING

    Burlington, Vermont, 05401, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.