Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach

Completed · Phase 3

Conditions studied: Neonatal Opiate Withdrawal Syndrome

In brief

This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today: 1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper. 2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given. We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS.

Key facts

Study ID

NCT05980260

Run by

HELP for NOWS Consortium

People needed

626

Starts

2024-03-25

Expected to finish

2025-07-15

Last updated by the study team

2026-05-18

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The infant is greater than or equal to 36 weeks gestation.
• 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.
• 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 FNAST or modification thereof
• At least 1 "yes" if assessed and managed with the ESC care approach

You may not qualify if…

• The infant has major birth defect(s).
• 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.
• The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
• The infant has undergone major surgical intervention prior to or at 48 hours of age.
• The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS.
• The infant was outborn and pharmacologic treatment was initiated at the transferring hospital.
• The infant is assessed for eligibility during the study site's three-week washout period.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• ChristianaCare — Wilmington, Delaware, United States
• University of South Florida Health — Tampa, Florida, United States
• Sidney & Lois Eskenazi Hospital — Indianapolis, Indiana, United States
• University of Louisville Hospital — Jeffersonville, Indiana, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States
• Kentucky Children's Hospital — Lexington, Kentucky, United States
• Norton Children's Hospital — Louisville, Kentucky, United States
• Norton Women's and Children's Hospital — Louisville, Kentucky, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• AtlantiCare Regional Medical Center — Atlantic City, New Jersey, United States
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Kettering Health Main Campus — Kettering, Ohio, United States
• Oklahoma Children's Hospital OU Health — Oklahoma City, Oklahoma, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• University of Utah Health — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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