Sildenafil for Bronchopulmonary Dysplasia (SILDI-SAFE Trial)

Recruiting in Palo Alto (17 mi)

+29 other locations

Overseen ByMatt Laughon, MD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Christoph Hornik

Prior Safety Data

Approved in 5 jurisdictions

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for premature infants in NICUs with severe bronchopulmonary dysplasia. Eligible babies are 32-44 weeks postmenstrual age, born before 29 weeks gestation, and need respiratory support. Parents must consent to participate. Infants can't join if they've had certain heart defects, sickle cell disease, recent vasopressors or nitric oxide use, high liver enzymes, or known sildenafil allergy.

Inclusion Criteria

I am on a breathing machine or CPAP depending on my baby's age in weeks.

I was born before reaching 29 weeks of pregnancy.

My baby is between 32 and 44 weeks in developmental age.

Exclusion Criteria

I have not taken milrinone in the last 24 hours.

I have sickle cell disease.

I haven't taken any vasopressor medications in the last 24 hours.

I had surgery or needed treatment for a heart defect I was born with.

I was previously enrolled and received treatment in the NHLBI-2019-SIL study for severe BPD.

I have not taken sildenafil in the last 7 days.

Participant Groups

The study tests the safety of Sildenafil compared to a placebo in helping premature infants with severe lung problems (BPD). It's randomized (babies are put into groups by chance), double-masked (neither doctors nor parents know which treatment the baby gets), and dose levels increase over time.

6Treatment groups

Active Control

Placebo Group

Group I: Cohort 1, sildenafilActive Control1 Intervention

Sildenafil (0.5 mg/kg IV or 1 mg/kg enteral) every 8 hours for 28 days

Group II: Cohort 3, sildenafilActive Control1 Intervention

Sildenafil (2 mg/kg IV or 4 mg/kg enteral) every 8 hours for 28 days

Group III: Cohort 2, sildenafilActive Control1 Intervention

Sildenafil (1 mg/kg IV or 2 mg/kg enteral) every 8 hours for 28 days

Group IV: Cohort 2, placeboPlacebo Group1 Intervention

Placebo (IV or enteral) every 8 hours for 28 days

Group V: Cohort 3, placeboPlacebo Group1 Intervention