Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT07278375 · ClinicalTrials.gov registry record

Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

A clinical trial of Neonatal Opioid Withdrawal Syndrome, sponsored by HELP for NOWS Consortium.

Recruiting
Registry status
796
Enrollment target
20
Study locations

NCT07278375 is a study of Neonatal Opioid Withdrawal Syndrome that is actively recruiting participants, run by HELP for NOWS Consortium. The registered enrollment target is 796 participants, above the 121-participant average among 7 other Neonatal Opioid Withdrawal Syndrome trials with a reported enrollment target (558% higher). The trial reports 20 study locations across 11 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT07278375, a study of Neonatal Opioid Withdrawal Syndrome, is actively recruiting participants, sponsored by HELP for NOWS Consortium.

RECRUITING
Registry status
796 participants
Enrollment target
20
Study locations

Study 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. 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.

Conditions Studied

Neonatal Opioid Withdrawal Syndrome

Study Locations (20)

Kentucky

  • St. Elizabeth Healthcare - Edgewood
  • Kentucky Children's Hospital - Lexington
  • Norton Children's Hospital - Louisville
  • Norton Women's and Children's Hospital - Louisville

Indiana

  • Riley Hospital for Children at IU Health - Indianapolis
  • Sidney & Lois Eskenazi Hospital - Indianapolis
  • University of Louisville Hospital - Jeffersonville

Ohio

  • Good Samaritan Hospital - Cincinnati
  • Cincinnati Children's Hospital Medical Center - Cincinnati
  • Rainbow Babies and Children's Hospital - Cleveland

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia
  • Pennsylvania Hospital - Philadelphia
  • Thomas Jefferson University Hospital - Philadelphia

Alabama

  • University of Alabama at Birmingham - Birmingham

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

Delaware

  • ChristianaCare - Wilmington

Florida

  • University of South Florida Health - Tampa

Trial Details

FieldValue
Enrollment Target 796 participants
Start Date 2025-12-09
Est. Completion 2026-08-30

Sponsor

HELP for NOWS Consortium

2 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07278375

The ClinicalTrials.gov registry entry for NCT07278375 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 796 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 121-participant average among 7 other Neonatal Opioid Withdrawal Syndrome trials with a reported enrollment target (558% higher). The listed sponsor is HELP for NOWS Consortium, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neonatal Opioid Withdrawal Syndrome appearing as the primary indexed condition, and to 0 interventions.

NCT07278375 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Kentucky, Indiana, Ohio.

Frequently Asked Questions

What is clinical trial NCT07278375 about?

NCT07278375 is a clinical study titled "Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome". 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 b...

What is the current status of trial NCT07278375?

This trial is currently recruiting. The enrollment target is 796 participants. The study started on 2025-12-09. Estimated completion is 2026-08-30.

What conditions does trial NCT07278375 study?

This clinical trial studies the following conditions: Neonatal Opioid Withdrawal Syndrome.

Who is sponsoring clinical trial NCT07278375?

This trial is sponsored by HELP for NOWS Consortium, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07278375 being conducted?

This trial has 20 study locations across Alabama, Arkansas, Delaware, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Neonatal Opioid Withdrawal Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Neonatal Opioid Withdrawal Syndrome

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.