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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03142568
The ClinicalTrials.gov registry entry for NCT03142568 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (53% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
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 reports 15 study locations spanning 13 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.