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Phosphodiesterase-5 Inhibitor

Sildenafil for Bronchopulmonary Dysplasia (SIL02 Trial)

Phase 2
Recruiting
Led By Matthew M Laughon, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving positive airway pressure (nasal continuous airway pressure, nasal intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or mechanical ventilation (high frequency or conventional)
<29 weeks gestational age at birth
Must not have
Currently receiving vasopressors
Currently receiving inhaled nitric oxide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days for each participant

Summary

This trial will determine the safety and effectiveness of sildenafil in premature infants.

Who is the study for?
This trial is for premature infants born before 29 weeks of gestation, who need help breathing and are between 7-28 days old. Infants cannot participate if they have certain liver issues, blood pressure lower than a specific threshold, are on blood pressure medications, have an allergy to sildenafil, are receiving inhaled nitric oxide or have sickle cell disease.
What is being tested?
The study is testing the safety and initial effectiveness of sildenafil in these young patients at risk for lung problems (bronchopulmonary dysplasia). It will also look at how the drug moves through and leaves their bodies. Some babies will get sildenafil while others will receive a placebo with no active medicine.
What are the potential side effects?
While not specified here, common side effects of sildenafil in adults include headaches, flushing, upset stomachs and vision changes. In premature infants however, potential side effects may differ significantly due to their age and medical condition.

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 support machine or receiving high-flow oxygen.
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I was born before reaching 29 weeks of pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication to raise my blood pressure.
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I am currently using inhaled nitric oxide.
Select...
I have sickle cell disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days for each participant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for each participant 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 as determined by adverse event experienced by participants
Secondary study objectives
Area Under the Curve (AUC)
Change in moderate-severe BPD or death risk from baseline
Clearance
+3 more

Side effects data

From 2018 Phase 4 trial • 6 Patients • NCT01642407
50%
Bronchitis
50%
Nasopharyngitis
50%
Upper respiratory tract infection
33%
Headache
33%
Epistaxis
33%
Diarrhoea
33%
Gastroenteritis
17%
Eczema
17%
Vision blurred
17%
Rash
17%
Flushing
17%
Alanine aminotransferase increased
17%
Ammonia increased
17%
Aspartate aminotransferase increased
17%
Weight increased
17%
Dysmenorrhoea
17%
Erection increased
17%
Pulmonary arterial hypertension
17%
Rhinitis allergic
17%
Acne
17%
Dermatitis diaper
17%
Dry skin
17%
Visual acuity reduced transiently
17%
Colitis
17%
Molluscum contagiosum
17%
Streptococcal infection
17%
Blood urine present
17%
Myalgia
17%
Cardiac failure
17%
Conjunctivitis allergic
17%
Dental caries
17%
Vomiting
17%
Chest pain
17%
Feeling abnormal
17%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sildenafil

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Sildenafil cohort 3Experimental Treatment1 Intervention
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Group II: Sildenafil cohort 2Experimental Treatment1 Intervention
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Group III: Sildenafil cohort 1Experimental Treatment1 Intervention
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Group IV: Placebo cohort 3Placebo Group1 Intervention
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Group V: Placebo cohort 1Placebo Group1 Intervention
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Group VI: Placebo cohort 2Placebo Group1 Intervention
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil
2008
Completed Phase 4
~1690

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,067 Previous Clinical Trials
2,747,324 Total Patients Enrolled
13 Trials studying Bronchopulmonary Dysplasia
10,979 Patients Enrolled for Bronchopulmonary Dysplasia
The Emmes Company, LLCIndustry Sponsor
147 Previous Clinical Trials
1,052,018 Total Patients Enrolled
2 Trials studying Bronchopulmonary Dysplasia
5,082 Patients Enrolled for Bronchopulmonary Dysplasia
University of North Carolina, Chapel HillLead Sponsor
1,568 Previous Clinical Trials
4,301,964 Total Patients Enrolled
3 Trials studying Bronchopulmonary Dysplasia
462 Patients Enrolled for Bronchopulmonary Dysplasia
Duke UniversityOTHER
2,462 Previous Clinical Trials
2,964,240 Total Patients Enrolled
3 Trials studying Bronchopulmonary Dysplasia
5,342 Patients Enrolled for Bronchopulmonary Dysplasia
Matthew M Laughon, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
2 Previous Clinical Trials
170 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
136 Patients Enrolled for Bronchopulmonary Dysplasia

Media Library

Sildenafil (Phosphodiesterase-5 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03142568 — Phase 2
Bronchopulmonary Dysplasia Research Study Groups: Sildenafil cohort 1, Placebo cohort 3, Placebo cohort 1, Placebo cohort 2, Sildenafil cohort 3, Sildenafil cohort 2
Bronchopulmonary Dysplasia Clinical Trial 2023: Sildenafil Highlights & Side Effects. Trial Name: NCT03142568 — Phase 2
Sildenafil (Phosphodiesterase-5 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03142568 — Phase 2
~3 spots leftby Feb 2025
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