Phase 2
N=106
Safety of Sildenafil in Premature Infants
Bronchopulmonary Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT03142568 ↗Enrolled (actual)
106
Serious AEs
14.7%
Results posted
Mar 2026
Primary outcome: Primary: Safety as Determined by Adverse Event Experienced by Participants — 71; 83; 53; 60 Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sildenafil (Drug); Placebo (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety as Determined by Adverse Event Experienced by Participants |
71; 83; 53; 60 | — |
| SECONDARY Volume of Distribution |
3.01; 3.67; 3.07 | — |
| SECONDARY Clearance |
1.23; 1.54; 1.30 | — |
| SECONDARY Half-Life |
7.89; 7.87; 7.46 | — |
| SECONDARY Area Under the Curve (AUC) |
174.0; 610.50; 1196.78 | — |
| SECONDARY Peak Plasma Concentration |
11.51; 39.72; 84.36 | — |
| SECONDARY Change in Moderate-severe BPD or Death |
66.3; 68.4; 55.2; 70.9; 66.0; 60.2 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Receiving positive airway pressure (nasal continuous airway pressure, nasal intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or mechanical ventilation (high frequency or conventional)
- 225 U/L 150 U/L < 72 hours prior to randomization
Data sourced from ClinicalTrials.gov (NCT03142568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.