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Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia

NCT04447989 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-01-26

Study results available
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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).

Conditions

  • Bronchopulmonary Dysplasia of Newborn

Interventions

DRUG

Sildenafil

Sildenafil citrate injection or powder for suspension

DRUG

Placebo

dextrose 5%

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Christoph Hornik

    lead OTHER

Principal Investigators

  • Christoph Hornik, MD · Duke UMC

  • Matt Laughon, MD · UNC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
29 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2024-12-12
Completion
2025-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04447989 on ClinicalTrials.gov