Single-dose Prophylactic INdomethacin in Extremely Preterm Infants

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

March 31, 2031

Conditions
Extreme PrematurityIntraventricular HemorrhageMorbidity;Newborn
Interventions
DRUG

Indomethacin

Single dose of 0.1 mg/kg dose intravenous indomethacin as a slow infusion over 20 mins

DRUG

Placebo

Single dose of intravenous normal saline placebo as a slow infusion over 20 mins

Trial Locations (15)

76104

Texas Health Harris Methodist Hospital Fort Worth, Fort Worth

Welcome to Baylor Scott & White Health, Fort Worth

95661

Kaiser Roseville, Roseville

95817

UC Davis Health, Sacramento

15224-1334

University of Pittsburgh School of Medicine, Pittsburgh

Unknown

Mercy Hospital for Women, Melbourne

Monash Children's Hospital, Melbourne

Foothills Medical Center & Alberta Children's Hospital, Calgary

Royal Alexandra Hospital, Edmonton

Royal Columbian Hospital, New Westminster

IWK Health, Halifax

Sunnybrook Health Sciences Centre, Toronto

Montreal Children's Hospital, Montreal

CHU de Quebec, Québec

V6H 3N1

BC Women's Hospital, Vancouver

All Listed Sponsors
lead

University of British Columbia

OTHER