NCT03142568

Safety of Sildenafil in Premature Infants

Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 7 Days – 28 Days
• Healthy volunteers: Not accepted

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).

Detailed description

This will be a multi-center, randomized, placebo-controlled, sequential dose escalating, double masked, safety data study of sildenafil in premature infants. This is a Phase II study design, premature infants (inpatient in neonatal intensive care units) will be randomized in a dose escalating approach 3:1 (sildenafil: placebo) into 3 cohorts with escalating doses of sildenafil. There will be 40 randomized and dosed participants in each cohort for a total of up to 120 participants. Cohort 1 sildenafil dose will be 0.125 mg/kg q 8 hours IV or 0.25 mg/kg q 8 hours enteral. Cohort 2 sildenafil dose will be 0.5 mg/kg q 8 hours IV or 1.0 mg/kg q 8 hours enteral. Cohort 3 sildenafil dose will be 1 mg/kg q 8 hours IV or 2 mg/kg q 8 hours enteral.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-04-02
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2017-05-05
• Last updated: 2026-03-30
• Results posted: 2026-03-11

Locations

15 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study