CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled
Drug / intervention
Sildenafil +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03142568
NCT03142568Phase 2Completed
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Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia

University of North Carolina, Chapel Hill·interventional·Posted May 5, 2017·Updated Mar 30, 2026

In Brief

A Phase 2 clinical trial evaluating Sildenafil and Placebo for Bronchopulmonary Dysplasia. Completed, enrolled 109 participants across 15 sites in 2 countries.

Detailed Summary

Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil. Funding Source - FDA Office of Orphan Products Development (OOPD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchopulmonary Dysplasia
CountriesCanada, United States
CollaboratorsDuke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Emmes Company, LLC

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 5, 2017
Enrollment StartApr 2, 2018
Primary CompletionMar 1, 2025
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 9.2 years ago

Interventions

Sildenafildrug

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

Placeboother

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).