Safety of Sildenafil in Premature Infants

Completed · Phase 2 · Has a placebo group

Conditions studied: Bronchopulmonary Dysplasia

In brief

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).

Key facts

Study ID

NCT03142568

Run by

University of North Carolina, Chapel Hill

People needed

109

Starts

2018-04-02

Expected to finish

2025-03-01

Last updated by the study team

2026-03-30

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• <29 weeks gestational age at birth
• 7-28 (inclusive) days postnatal age at time of randomization

You may not qualify if…

• Currently receiving vasopressors
• Currently receiving inhaled nitric oxide
• Baseline mean arterial pressure < gestational age (in weeks) plus postnatal age (in weeks) within 2 hours of sildenafil administration
• Known allergy to sildenafil
• Known sickle cell disease
• Aspartate Aminotransferase (AST) > 225 U/L < 72 hours prior to randomization
• Alanine Aminotransferase (ALT) > 150 U/L < 72 hours prior to randomization

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• University of Florida College of Medicine Jacksonville-Wolfson Children's Hospital — Jacksonville, Florida, United States
• University of Florida Jacksonville Shands Medical Center — Jacksonville, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Wesley Medical Center — Wichita, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Baptist Medical Center — New Orleans, Louisiana, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Children's Hospital of Nevada at UMC — Las Vegas, Nevada, United States
• Monmouth Medical Center — Long Branch, New Jersey, United States
• Cohen Children's Medical Center of NY — New Hyde Park, New York, United States
• Golisano Children's Hospital - University of Rochester Medical Center — Rochester, New York, United States
• WakeMed Health and Hospitals — Raleigh, North Carolina, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Health Sciences Centre Hospital — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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