NCT07278375 · HELP for NOWS Consortium
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
(TreaT NOW)
What this study is about
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.
View original scientific description
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? 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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.
Where
- Birmingham, Alabama
- Little Rock, Arkansas
- Wilmington, Delaware
- Tampa, Florida
- Indianapolis, Indiana
- Jeffersonville, Indiana
- Edgewood, Kentucky
- Lexington, Kentucky
- Louisville, Kentucky
- Camden, New Jersey
- Albuquerque, New Mexico
- Rochester, New York
And 5 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2026 · Source of record for eligibility and locations