Sildenafil for Bronchopulmonary Dysplasia (SILDI-SAFE Trial)

Phase 2

Recruiting

Led By Christoph Hornik, MD

Research Sponsored by Christoph Hornik

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving respiratory support at enrollment: If 32 0/7-35 6/7 weeks postmenstrual age: mechanical ventilation (high frequency or conventional). If 36 0/7-44 6/7 weeks postmenstrual age: mechanical ventilation (high frequency or conventional) OR continuous positive airway pressure (CPAP).

< 29 weeks gestational age at birth

Must not have

Previous exposure to milrinone within 24 hours prior to randomization*

Known sickle cell disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up blood samples will be collected after any dose following the completion of 7 days (168 hours) of study drug administration.

Summary

This trial is testing if sildenafil, a drug typically used to treat erectile dysfunction, is safe for premature infants with severe BPD.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Sildenafil in infants could include low blood pressure, bleeding episodes, seizures, or digestive issues. However, this study primarily aims to assess its safety profile at different doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I was born before reaching 29 weeks of pregnancy.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken milrinone in the last 24 hours.

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I have sickle cell disease.

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

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

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

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I have not taken sildenafil in the last 7 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood samples will be collected after any dose following the completion of 7 days (168 hours) of study drug administration.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood samples will be collected after any dose following the completion of 7 days (168 hours) of study drug administration.

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples will be collected after any dose following the completion of 7 days (168 hours) of study drug administration. for reporting.