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Safety of Sildenafil in Premature Infants

NCT03142568 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2026-03-30

Study results available
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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

  • Bronchopulmonary Dysplasia

Interventions

DRUG

Sildenafil

Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.

OTHER

Placebo

Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Matthew M Laughon, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-02
Primary Completion
2025-03-01
Completion
2025-03-01
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT03142568 on ClinicalTrials.gov