Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

189

Participants

Timeline

Start Date

September 28, 2020

Primary Completion Date

January 31, 2024

Study Completion Date

June 30, 2026

Conditions
Neonatal Opioid Withdrawal Syndrome
Interventions
DRUG

Morphine

The dose interval for morphine will be either every 3 or 4 hours, per hospital practice. Clinical teams are asked to wean study drug at least every 24 hours.

DRUG

Methadone

The dose interval for methadone will be every 8 or 12 hours, per hospital practice. Clinical teams are asked to wean study drug at least every 24 hours.

Trial Locations (24)

20782

MedStar Franklin Square, Hyattsville

26506

West Virginia University Hospital, Morgantown

27705

RTI International, Durham

35249

University of Alabama at Birmingham, Birmingham

38119

University of Tennessee Health Science Center, Memphis

38163

The University of Tennessee Health Science Center, Memphis

43205

Nationwide Childeren's Hospital, Columbus

43210

Ohio State University Hospital, Columbus

44109

Metrohealth, Cleveland

48201

Central Michigan University, Detroit

52242

University of Iowa, Iowa City

57104

Sanford Health, Sioux Falls

63110

Washington University School of Medicine, St Louis

64108

Children's Mercy Hospital, Kansas City

70001

Tulane University Health Science Center, New Orleans

70065

Ochsner Medical Regional Hospital, Kenner

70115

Ochsner Baptist Clinical Trials Unit, New Orleans

72202

University of Arkansas Medical Sciences, Little Rock

85724

University of Arizona, Tucson

87131

University of New Mexico, Albuquerque

92123

Sharp Mary Birch Hospital for Women and Newborns, San Diego

92354

Loma Linda University Medical Center, Loma Linda

01605

University of Massachusetts Memorial Medical Center-West Campus, Worcester

02905

Women & Infants Hospital of Rhode Island, Providence

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

NETWORK

NCT04214834 - Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) | Biotech Hunter | Biotech Hunter