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Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
Sponsor: HELP for NOWS Consortium
Summary
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 Details
Gender
All
Age Range
1 Hour - 48 Hours
Study Type
INTERVENTIONAL
Enrollment
626
Start Date
2024-03-25
Completion Date
2025-07-15
Last Updated
2026-05-18
Healthy Volunteers
No
Conditions
Interventions
Symptom-based Dosing Approach
During this approach to care, all enrolled infants with NOWS at the study site will be treated with the symptom-based dosing approach if they meet the withdrawal threshold for pharmacologic treatment. Participants may receive up to 3 doses of the study site's preferred opioid during a 24-hour period to treat signs of withdrawal once the threshold for pharmacologic intervention is met. If a 4th dose is required within a 24-hour period, the study site will transition to the scheduled opioid taper algorithm used at the study site to complete the infant's pharmacologic treatment.
Scheduled Opioid Taper Approach
During this approach to care, all enrolled infants with NOWS at the study site will be treated with the study site's usual scheduled opioid taper approach, as detailed in each site's treatment algorithm, if they meet the withdrawal threshold for pharmacologic treatment.
Locations (23)
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