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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.

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I have sickle cell disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 days for each participant

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%

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