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Neonatal Opioid Withdrawal SyndromeTreaT NOWNCT07278375

Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

An observational study of Neonatal Opioid Withdrawal Syndrome, run by HELP for NOWS Consortium at 22 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS). The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 0 minutes and older
Conditions the study is for
Neonatal Opioid Withdrawal Syndrome
How many people
796 participants
Where
22 sitesUnited States
Study dates
9 Dec 2025to 30 Aug 2026
How long will I take part?
90 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 minutes and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Infant is ≥ 36 weeks' gestational age
  • Infant had antenatal opioid exposure identified by at least one of the following:
  • 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;
  • 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.
  • The infant is being assessed and managed for NOWS at an eligible study site.
Show all 10Show fewer
  • 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
  • Infant met all inclusion criteria on or after March 25, 2024.

Who cannot join

  • Infant has major congenital anomalies.
  • 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.
  • Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
  • Infant has undergone major surgical intervention prior to or at 48 hours of age.
  • Infant has postnatal opioid exposure prior to the initiation of pharmacologic treatment for NOWS.
  • Infant was outborn and pharmacologic treatment was initiated at the transferring hospital.

Trial locations and contacts

22 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Walter K Kraft, MD contact

215-955-9077

Walter.Kraft@jefferson.edu

22 sites in 1 country

United States22 sites, 22 recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131

    Lawrence Leeman, MD, MPH, 505-272-2165, LLeeman@salud.unm.edu

    Lawrence M Leeman, MD, MPH

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Namasivayam Ambalavanan, MD

    Namasivayam Ambalavanan, MD

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Adrienne Pahl, MD, 802-847-2700, Adrienne.Pahl@uvmhealth.org

    Adrienne Pahl, MD

    Not yet recruiting

  • Children's Regional Hospital, Cooper University Health Care

    Camden, New Jersey, 08103

    Alla Kushnir, MD, FAAP, 856-342-2265, kushnir-alla@CooperHealth.edu

    Alla Kushnir, MD, FAAP

    Not yet recruiting

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45202

    Stephanie Merhar, MD, MS, 513-803-5180, Stephanie.Merhar@cchmc.org

    Stephanie Merhar, MD, MS

    Not yet recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Stephanie Merhar, MD, MS, 513-803-5180, Stephanie.Merhar@cchmc.org

    Stephanie Merhar, MD, MS

    Not yet recruiting

  • Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106

    Moira Crowley, MD, 216-844-3759, Moira.Crowley@UHhospitals.org

    Moira Crowley, MD

    Not yet recruiting

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

    Stephanie Merhar, MD, MS, 513-803-5180, stephanie.merhar@cchmc.org

    Stephanie Merhar, MD, MS

    Not yet recruiting

  • Riley Hospital for Children at IU Health

    Indianapolis, Indiana, 46202-5119

    Gregory Sokol, MD, 317-274-8021, gsokol@iu.edu

    Gregory Sokol, MD

    Recruiting

  • Sidney & Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

    Gregory Sokol, MD, 317-274-8021, gsokol@iu.edu

    Gregory Sokol, MD

    Recruiting

  • University of Louisville Hospital

    Jeffersonville, Indiana, 47130

    Lori Devlin, DO, MHA, MS, 502-852-8470, lori.devlinphinney@louisville.edu

    Lori Devlin, DO, MHA, MS

    Not yet recruiting

  • Kentucky Children's Hospital

    Lexington, Kentucky, 40536

    Thitinart Sithisarn, MD, PhD, 859-257-6481, tsith2@uky.edu

    Thitinart Sithisarn, MD, PhD, FAAP

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205-7199

    Richard W Hall, MD, 501-686-8000, HallRichardW@uams.edu

    Richard W Hall, MD

    Recruiting

  • Norton Children's Hospital

    Louisville, Kentucky, 40202

    Lori Devlin, DO, MHA, MS, 502-852-8470, lori.devlinphinney@louisville.edu

    Lori Devlin, DO, MHA, MS

    Not yet recruiting

  • Norton Women's and Children's Hospital

    Louisville, Kentucky, 40207

    Lori Devlin, DO, MHA, MS, 502-852-8470, lori.devlinphinney@louisville.edu

    Lori Devlin, DO, MHA, MS

    Not yet recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Scott Lorch, MD, MSCE, 215-590-1653, LORCH@chop.edu

    Scott Lorch, MD, MSCE

    Recruiting

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

    Karen Puopolo, MD, PhD, 215-829-3301, Karen.Puopolo@pennmedicine.upenn.edu

    Karen Puopolo, MD, PhD

    Not yet recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Walter Kraft, MD, 501-686-8000, Walter.Kraft@jefferson.edu

    Walter K Kraft, MD

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Joseph Bliss, MD, PhD, 585-275-9767, joseph_bliss@urmc.rochester.edu

    Joseph Bliss, MD, PhD

    Not yet recruiting

  • University of Utah Health

    Salt Lake City, Utah, 84158

    Bhanu Muniyappa, MD, 801-581-2205, Bhanu.Muniyappa@hsc.utah.edu

    Bhanu Muniyappa, MD

    Not yet recruiting

  • University of South Florida Health

    Tampa, Florida, 33606

    Tanner Wright, MD, FAAP, 321-217-2235, twright5@usf.edu

    Tanner Wright, MD, FAAP

    Recruiting

  • ChristianaCare

    Wilmington, Delaware, 19801

    Kelley Kovatis, MD, 215-427-5000, Kelley.Kovatis@ChristianaCare.org

    Kelley Z Kovatis, MD

    Not yet recruiting

Other trials in United States

About this study

The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS). The main questions it aims to answer are:

  1. Do infants treated with buprenorphine become medically ready for discharge sooner than those treated with morphine?
  2. Does one treatment lead to better overall clinical outcomes than the other?
Read more

Researchers will compare infants who received buprenorphine with infants who received morphine to see whether one treatment helps babies recover more quickly.

Participants will not be asked to do anything. Instead, the study team will collect information already documented in the infant's and mother's medical records securely without any contact or changes to clinical care.

No new medicines, procedures, or visits are involved. This study only reviews existing clinical data to better understand which commonly used treatment may support faster recovery for newborns with NOWS.

Read the detailed description

Neonatal Opioid Withdrawal Syndrome (NOWS) occurs in infants who were exposed to opioids during pregnancy and may lead to symptoms such as irritability, feeding difficulties, and trouble sleeping. Many hospitals treat these symptoms with either morphine or buprenorphine, but it is not yet known whether one medication helps infants recover more quickly. This study aims to answer that question by reviewing information already documented in medical records from hospitals that routinely use one of these treatments.

The study will include approximately 796 infants, all born at 36 weeks' of gestation or later and treated for NOWS with either buprenorphine or morphine as part of usual clinical care. Data will be collected from about 22 hospitals across the United States. Researchers will review existing medical record information such as the infant's birth characteristics, withdrawal symptoms, details of treatment (including medication choice and dosing approach), feeding practices, non-pharmacologic care, and clinical outcomes-including the key measure of how long it took for the infant to become medically ready for discharge.

Because treatment decisions are made by the clinical team and not assigned by the study, researchers will use advanced statistical methods to compare outcomes between infants who received buprenorphine and those who received morphine. These methods allow the team to adjust for differences between infants and hospitals, helping ensure that comparisons are as fair and accurate as possible. The goal is to estimate how outcomes would differ if all infants received one medication versus the other in real-world practice.

No infants or parents will be contacted for this study, and no additional treatments, tests, or procedures will be performed. All data come from routine clinical care. The regulatory review for this project determined that informed consent from families is not required because the study uses only existing medical information and does not involve any interaction with participants or changes to medical care. All collected data will be handled securely and in compliance with federal privacy requirements.

The information learned from this research may help improve care for future infants with NOWS by providing clearer evidence on how commonly used treatments compare in supporting recovery.

Keywords
Neonatal Opioid Withdrawal Syndrome, NOWS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07278375
Study groupRoleWhat they receive
Infants treated with buprenorphineInfants treated with buprenorphine as the primary opioid for NOWS
Infants treated with morphineInfants treated with morphine as the primary opioid for NOWS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from birth until infant meets criteria for medically ready for discharge (count)

    Number of days from birth until infant meets criteria for medically ready for discharge. An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet both of the following criteria:

    • 96 hours of age
    • 48 hours since last dose of treatment with morphine or buprenorphine

    Measured: From date of birth until date of infant meeting criteria for medically ready for discharge (estimated to be < 90 days).

Secondary outcomes (8)

  1. Length of hospital stay (count)

    Number of days between birth and hospital discharge

    Measured: From date of birth until date of hospital discharge (estimated to be < 90 days).

  2. Length of primary opioid treatment (count)

    Number of days between the first and the last primary opioid dose administered

    Measured: From date of birth until date of last primary opioid dose administration (estimated to be < 90 days).

  3. Number of primary opioid doses administered (count)

    Number of primary opioid doses administered (count)

    Measured: From date of birth until date of last primary opioid dose administration (estimated to be < 90 days).

  4. Receipt of secondary medication (binary)

    Receipt of at least one dose of any amount of phenobarbital, clonidine, or some other non-opioid medication as a secondary medication

    Measured: From date of birth until date of first non-opioid secondary medication administration or until date of hospital discharge, whichever comes first (estimated to be < 90 days).

  5. Inpatient composite safety outcome (binary)

    Occurrence of at least one of the following events between birth and the last primary opioid dose administered:

    • Seizures
    • Excessive weight loss more than 15% from birthweight

    Measured: From date of birth until date of first occurrence of seizure or excessive weight loss more than 15% from birthweight or until date of last primary opioid dose administration, whichever comes first (estimated to be < 90 days).

  6. Inpatient composite critical safety outcome (binary)

    Occurrence of at least one of the following events between birth and the last primary opioid dose administered:

    • Non-accidental trauma
    • Death

    Measured: From date of birth until date of first occurrence of non-accidental trauma or death or until date of last primary opioid dose administration, whichever comes first (estimated to be < 90 days).

  7. Inpatient composite safety outcome after receipt of pharmacologic treatment (binary)

    Occurrence of at least one of the following events between first primary opioid dose administered and the data of hospital discharge:

    • Seizures
    • Excessive weight loss more than 15% from birthweight

    Measured: From date of first primary opioid dose administration until date of first occurrence of seizure or excessive weight loss more than 15% from birthweight or until date of hospital discharge, whichever comes first (estimated to be < 90 days).

  8. Inpatient composite critical safety outcome after receipt of pharmacologic treatment (binary)

    Occurrence of at least one of the following events between first primary opioid dose administered and hospital discharge:

    • Non-accidental trauma
    • Death

    Measured: From date of first primary opioid dose administration until date of first occurrence of non-accidental trauma or death or until date of hospital discharge, whichever comes first (estimated to be < 90 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start9 Dec 2025
  3. Primary completion19 Jun 2026 (estimated)
  4. Study completion30 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
796 participants (estimated)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07278375
Sponsor's protocol ID
HELP for NOWS 03
Other IDs
1U24HD107621, 1UG1HD107628, 1UG1HD107580, 1UG1HD107649, 1UG1HD107650, 1UG1HD107653, 1UG1HD107627, 1UG1HD107631
Acronym
TreaT NOW
Status last verified
Feb 2026
First submitted
21 Nov 2025
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data collected for this study will be analyzed and stored at the DCC, RTI International. NIH Helping to End Addiction Long-term Initiative (HEAL) and NICHD requirements for data-sharing will apply. NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. In accordance with these policies (available at HEAL Public Access and Data Sharing \| NIH HEAL Initiative), we will share de-identified data collected for the study. After the study is completed, the de-identified, archived data will be transmitted to a NIH HEAL supported repository, for use by other researchers including those outside of the study.

Questions about this trial

What is this clinical trial studying?

An observational study of Neonatal Opioid Withdrawal Syndrome, run by HELP for NOWS Consortium at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Walter K Kraft, MD (215-955-9077, Walter.Kraft@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from birth until infant meets criteria for medically ready for discharge (count) (time frame: From date of birth until date of infant meeting criteria for medically ready for discharge (estimated to be < 90 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07278375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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