Pharmacokinetics of Sildenafil in Premature Infants

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Persistent Pulmonary Hypertension of the Newborn
Interventions
DRUG

1 dose of sildenafil

A single IV dose of sildenafil will be administered over 90 minutes with no greater than a 15-minute flush. Final dose to be determined based on at least the first 4 participants enrolled in Cohort 1; final dose expected to be a single dose between 0.25 and 0.5 mg/kg.

Trial Locations (9)

11203

Kings County Hospital Center/SUNY Downstate Medical Center, Brooklyn

12208

Albany Medical Center, Albany

27599

University of North Carolina, Chapel Hill

27705

Duke University, Durham

29425

Medical University of South Carolina, Charleston

40202

Kosair Pediatric Research Unit, Louisville

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital, Indianapolis

35249-7335

University of Alabama at Birmingham, Birmingham

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