Safety of Sildenafil in Premature Infants

PHASE2CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

April 2, 2018

Primary Completion Date

January 3, 2025

Study Completion Date

January 3, 2025

Conditions
Bronchopulmonary Dysplasia
Interventions
DRUG

Sildenafil

Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.

OTHER

Placebo

Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).

Trial Locations (15)

11040

Cohen Children's Medical Center of NY, New Hyde Park

14642

Golisano Children's Hospital - University of Rochester Medical Center, Rochester

27610

WakeMed Health and Hospitals, Raleigh

32209

University of Florida College of Medicine Jacksonville-Wolfson Children's Hospital, Jacksonville

University of Florida Jacksonville Shands Medical Center, Jacksonville

39216

University of Mississippi Medical Center, Jackson

40356

University of Kentucky, Lexington

60612

University of Illinois at Chicago, Chicago

67214

Wesley Medical Center, Wichita

70115

Ochsner Baptist Medical Center, New Orleans

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma, Oklahoma City

89106

Children's Hospital of Nevada at UMC, Las Vegas

07740

Monmouth Medical Center, Long Branch

R3A 1R9

Health Sciences Centre Hospital, Winnipeg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Duke University

OTHER

collaborator

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

NIH

collaborator

The Emmes Company, LLC

INDUSTRY

lead

University of North Carolina, Chapel Hill

OTHER