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NCT03142568 · ClinicalTrials.gov registry record · Phase 2
Safety of Sildenafil in Premature Infants
A Phase 2 study of Bronchopulmonary Dysplasia, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
- 15
- Study locations
NCT03142568: Completed Phase 2 study of Bronchopulmonary Dysplasia, sponsored by University of North Carolina, Chapel Hill.
NCT03142568 is a Phase 2 study of Bronchopulmonary Dysplasia that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 109 participants, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (53% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03142568, a Phase 2 study of Bronchopulmonary Dysplasia, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
- 15
- Study locations
Study 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).
Primary Outcome
Description of safety of sildenafil in premature infants and assessed by frequency and incidence of adverse events (AEs) and serious adverse events. Both non-serious and serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Sildenafil
Study Locations (15)
Florida
- University of Florida College of Medicine Jacksonville-Wolfson Children's Hospital - Jacksonville
- University of Florida Jacksonville Shands Medical Center - Jacksonville
New York
- Cohen Children's Medical Center of NY - New Hyde Park
- Golisano Children's Hospital - University of Rochester Medical Center - Rochester
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Illinois
- University of Illinois at Chicago - Chicago
Kansas
- Wesley Medical Center - Wichita
Kentucky
- University of Kentucky - Lexington
Louisiana
- Ochsner Baptist Medical Center - New Orleans
Mississippi
- University of Mississippi Medical Center - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2018-04-02 |
| Est. Completion | 2025-03-01 |
| Phase | Phase 2 |
What the finished NCT03142568 record still lists
NCT03142568 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03142568 lists 15 locations in 13 states (Florida, New York, Arkansas).
Frequently Asked Questions
What is clinical trial NCT03142568 about?
NCT03142568 is a clinical study titled "Safety of Sildenafil in Premature Infants". 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).
What is the current status of trial NCT03142568?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2018-04-02. Estimated completion is 2025-03-01.
What conditions does trial NCT03142568 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia.
What interventions are being tested in trial NCT03142568?
The interventions under investigation include: Placebo (OTHER), Sildenafil (DRUG).
Who is sponsoring clinical trial NCT03142568?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03142568 being conducted?
This trial has 15 study locations across Arkansas, Florida, Illinois, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bronchopulmonary Dysplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03142568's enrollment target sits among peer trials
109 16th of 29 higher than 14 of 29 other Bronchopulmonary Dysplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bronchopulmonary Dysplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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