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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
7-28 (inclusive) days postnatal age at time of randomization
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days for each participant
Awards & highlights

SIL02 Trial 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.Check my eligibility
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.See study design
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.

SIL02 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby is between 7 and 28 days old.
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I am on a breathing support machine or receiving high-flow oxygen.
Select...
I was born before reaching 29 weeks of pregnancy.

SIL02 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety as determined by adverse event experienced by participants
Secondary outcome measures
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%
Rash
17%
Flushing
17%
Vision blurred
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

SIL02 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
1,962 Previous Clinical Trials
2,674,609 Total Patients Enrolled
11 Trials studying Bronchopulmonary Dysplasia
10,977 Patients Enrolled for Bronchopulmonary Dysplasia
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,371 Total Patients Enrolled
2 Trials studying Bronchopulmonary Dysplasia
5,082 Patients Enrolled for Bronchopulmonary Dysplasia
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,542 Total Patients Enrolled
3 Trials studying Bronchopulmonary Dysplasia
462 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

Frequently Asked Questions

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

How many participants are enrolled in this experiment?

"This medical trial necessitates 120 suitable participants. Eligible patients may enrol at the Children's Hospital of Nevada in Las Vegas or Wesley Medical Centre in Wichita, Kansas."

Answered by AI

Has the Federal Drug Administration sanctioned Sildenafil?

"A score of 2 was assigned to sildenafil due to the Phase 2 trial status, indicating that limited safety data has been collected but no efficacy studies have yet taken place."

Answered by AI

Is enrollment in this experiment open to qualified participants?

"Confirmed, this medical trial is open for recruitment according to information from clinicaltrials.gov. The initial posting date was April 2nd 2018 and the most recent update happened on October 5th 2022."

Answered by AI

Does the age limit for participation in this clinical trial extend beyond sixty years?

"This research project seeks out individuals who are aged between 7 Days and 28 Days years old."

Answered by AI

What demographic is the most suitable for enrollment in this medical experiment?

"This scientific trial seeks to enroll 120 neonates between 1 week and 4 weeks old, who are suffering from bronchopulmonary dysplasia. To qualify for the study, participants must be undergoing either positive airway pressure or mechanical ventilation (high frequency or conventional), have been born prior 29 weeks gestation age, and fall within the 7-28 day postnatal window upon randomization."

Answered by AI

For what primary purpose is Sildenafil regularly prescribed?

"Sildenafil has been demonstrated to address premature ejaculation, as well as NYHA functional class II and III pulmonary arterial hypertension."

Answered by AI

What other research initiatives have utilized Sildenafil to date?

"Initially studied in 2013 by Virginia Commonwealth University/Massey Cancer Center, sildenafil has since been subject to 18455 trials. Currently, 23 active studies are taking place with many of these based out of Las Vegas Nevada."

Answered by AI

Are there multiple facilities carrying out this investigation within the city limits?

"Patients have 8 different medical sites to choose from when enrolling in this clinical trial, including the Children's Hospital of Nevada at UMC in Las Vegas, Wesley Medical Center in Wichita, and Golisano Children's Hospital - University of Rochester Medical Center in Rochester."

Answered by AI
~5 spots leftby Aug 2024