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New study tests smarter dosing for newborns hooked on opioids

NCT ID NCT05980260

Symptom relief 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 626 full-term babies with neonatal opioid withdrawal syndrome (NOWS). Doctors compared two ways of giving medicine: one where babies get medicine at set times, and another where they only get medicine when they show withdrawal signs. The goal was to see which approach helps babies get ready to go home sooner.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
opioid (morphine, methadone, or buprenorphine)
What this could lead to
If successful, this could show that giving medicine only when symptoms appear is better than a fixed schedule, leading to shorter hospital stays for babies with NOWS.
What could go wrong
This trial is completed but results are not yet widely known. The approach may not work for all babies, and individual responses to opioids vary.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

626 people

The number who actually took part.

Started

Mar 2024

Finished

Jul 2025

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.

Ages

1 hour to 48 hours

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. The infant is greater than or equal to 36 weeks gestation. 2. The infant had antenatal opioid exposure identified by at least one of the following: * History of maternal opioid use during pregnancy; * Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or * 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 FNAST or modification thereof * At least 1 "yes" if assessed and managed with the ESC care approach Exclusion Criteria: 1. The infant has major birth defect(s). 2. The 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. The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age. 4. The infant has undergone major surgical intervention prior to or at 48 hours of age. 5. The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS. 6. The infant was outborn and pharmacologic treatment was initiated at the transferring hospital. 7. The infant is assessed for eligibility during the study site's three-week washout period.

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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 opiate withdrawal syndrome

Contacts and locations

Locations

  • AtlantiCare Regional Medical Center

    Atlantic City, New Jersey, 08401, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • ChristianaCare

    Wilmington, Delaware, 19801, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45202, United States

  • Kentucky Children's Hospital

    Lexington, Kentucky, 40536, United States

  • Kettering Health Main Campus

    Kettering, Ohio, 45429, United States

  • Norton Children's Hospital

    Louisville, Kentucky, 40202, United States

  • Norton Women's and Children's Hospital

    Louisville, Kentucky, 40207, United States

  • Oklahoma Children's Hospital OU Health

    Oklahoma City, Oklahoma, 73104, United States

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Sidney & Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202, United States

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • University of Louisville Hospital

    Jeffersonville, Indiana, 47130, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of South Florida Health

    Tampa, Florida, 33606, United States

  • University of Utah Health

    Salt Lake City, Utah, 84158, United States

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