CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 125 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/NCT04447989
NCT04447989Phase 2Completed
CompareCT.gov

Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia

Christoph Hornik·interventional·Posted Jun 25, 2020·Updated Jan 26, 2026

In Brief

A Phase 2 clinical trial evaluating Sildenafil and Placebo for Bronchopulmonary Dysplasia of Newborn. Completed, enrolled 125 participants across 25 sites.

Detailed Summary

This is a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study of sildenafil in premature infants (inpatient in Neonatal Intensive Care Units (NICUs)) with severe bronchopulmonary dysplasia (BPD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchopulmonary Dysplasia of Newborn
CountriesUnited States
CollaboratorsUniversity of North Carolina, Chapel Hill, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 25, 2020
Enrollment StartMay 27, 2021
Primary CompletionDec 12, 2024
Study CompletionJan 15, 2025
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.0 years ago

Interventions

Sildenafildrug

Sildenafil citrate injection or powder for suspension

Placebodrug

dextrose 5%