480
Participants
Start Date
March 25, 2024
Primary Completion Date
May 27, 2025
Study Completion Date
August 27, 2025
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.
University of Rochester Medical Center, Rochester
Children's Hospital of Philadelphia, Philadelphia
Pennsylvania Hospital, Philadelphia
Thomas Jefferson University Hospital, Philadelphia
ChristianaCare, Wilmington
University of South Florida Health, Tampa
University of Alabama at Birmingham, Birmingham
Norton Children's Hospital, Louisville
Norton Women's and Children's Hospital, Louisville
Kentucky Children's Hospital, Lexington
St. Elizabeth Healthcare, Edgewood
Good Samaritan Hospital, Cincinnati
Cincinnati Children's Hospital Medical Center, Cincinnati
Kettering Health Main Campus, Kettering
Sidney & Lois Eskenazi Hospital, Indianapolis
University of Louisville Hospital, Jeffersonville
University of Kansas Hospital, Kansas City
University of Nebraska Medical Center, Omaha
University of Arkansas for Medical Sciences, Little Rock
Oklahoma Children's Hospital OU Health, Oklahoma City
University of Utah Health, Salt Lake City
University of New Mexico Health Sciences Center, Albuquerque
AtlantiCare Regional Medical Center, Atlantic City
National Institutes of Health (NIH)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
HELP for NOWS Consortium
NETWORK