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Phosphodiesterase Inhibitor

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.
Awards & highlights

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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety based upon incidence of hypotension
Secondary study objectives
Area Under the Curve
Clearance
Half-life
+2 more
Other study objectives
Global rank

Trial Design

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
Placebo (IV or enteral) every 8 hours for 28 days
Group VI: Cohort 1, placeboPlacebo Group1 Intervention
Placebo (IV or enteral) every 8 hours for 28 days

Find a Location

Who is running the clinical trial?

Christoph HornikLead Sponsor
Christoph P Hornik, MD MPHLead Sponsor
2 Previous Clinical Trials
156 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,087 Total Patients Enrolled
23 Trials studying Bronchopulmonary Dysplasia
10,087 Patients Enrolled for Bronchopulmonary Dysplasia

Media Library

Sildenafil (Phosphodiesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04447989 — Phase 2
Bronchopulmonary Dysplasia Clinical Trial 2023: Sildenafil Highlights & Side Effects. Trial Name: NCT04447989 — Phase 2
Sildenafil (Phosphodiesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04447989 — Phase 2
Bronchopulmonary Dysplasia Research Study Groups: Cohort 1, sildenafil, Cohort 2, placebo, Cohort 3, placebo, Cohort 3, sildenafil, Cohort 1, placebo, Cohort 2, sildenafil
~0 spots leftby Oct 2024
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