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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
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

SILDI-SAFE Trial 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.Check my eligibility
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.See study design
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.

SILDI-SAFE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on a breathing machine or CPAP depending on my baby's age in weeks.
Select...
I was born before reaching 29 weeks of pregnancy.
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My baby is between 32 and 44 weeks in developmental age.

SILDI-SAFE Trial 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

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

SILDI-SAFE Trial Design

6Treatment groups
Active Control
Placebo Group
Group I: Cohort 3, sildenafilActive Control1 Intervention
Sildenafil (2 mg/kg IV or 4 mg/kg enteral) every 8 hours for 28 days
Group II: Cohort 1, sildenafilActive Control1 Intervention
Sildenafil (0.5 mg/kg IV or 1 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
3,820 Previous Clinical Trials
47,299,317 Total Patients Enrolled
22 Trials studying Bronchopulmonary Dysplasia
9,957 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 3, sildenafil, Cohort 1, sildenafil, Cohort 2, placebo, Cohort 3, placebo, Cohort 1, placebo, Cohort 2, sildenafil

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration authorized sildenafil for Cohort 2?

"Cohort 2, sildenafil, received a safety rating of 2 on our scale due to its current status as being in the Phase 2 trial stage - meaning there is evidence confirming its safety profile but no data supporting efficacy yet."

Answered by AI

What therapeutic purposes does Cohort 2, sildenafil typically serve?

"Sildenafil, part of Cohort 2, is a viable treatment option for premature ejaculation, NYHA Functional Class II-III Pulmonary Arterial Hypertension and Pulmonary Arterial Hypertension."

Answered by AI

Is this experiment recruiting participants now?

"As verified by clinicaltrials.gov, this trial is actively searching for participants with the first post made on May 27th 2021 and most recent update occurring June 14th 2022."

Answered by AI

What conclusions have prior research efforts yielded regarding Cohort 2 and sildenafil?

"Sildenafil was first assessed in 2013 by the Virginia Commonwealth University/Massey Cancer Center; there are now 18,451 concluded studies. In addition to these completed trials, 23 active investigations of sildenafil are underway, many conducted out of New Orleans."

Answered by AI

How many health centers are administering the trial?

"13 clinical sites are currently conducting this medical trial. The list of locations includes New Orleans, Chicago and Atlanta as well as a further 10. For the sake of convenience, it is suggested that prospective participants select their closest clinic to minimize travel demands."

Answered by AI

How many participants have signed up for this medical experiment?

"The current recruitment drive seeks 120 participants that adhere to the established parameters. Participants can join the trial from multiple medical centres, including Ochsner Baptist Medical Center in New Orleans and Lurie Children's Hospital in Chicago."

Answered by AI
Recent research and studies
~18 spots leftby Oct 2024