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Sildenafil for Bronchopulmonary Dysplasia (SIL02 Trial)
SIL02 Trial Summary
This trial will determine the safety and effectiveness of sildenafil in premature infants.
SIL02 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSIL02 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 4 trial • 6 Patients • NCT01642407SIL02 Trial Design
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Who is running the clinical trial?
Media Library
- I was born before reaching 29 weeks of pregnancy.I am currently on medication to raise my blood pressure.My baby is between 7 and 28 days old.My blood pressure is lower than expected for my age in weeks, before taking sildenafil.I am on a breathing support machine or receiving high-flow oxygen.I am currently using inhaled nitric oxide.Your AST liver enzyme levels are too high within 72 hours before the study starts.You are allergic to sildenafil.I have sickle cell disease.Your ALT level is higher than 150 U/L within 72 hours before the study starts.
- Group 1: Sildenafil cohort 1
- Group 2: Placebo cohort 3
- Group 3: Placebo cohort 1
- Group 4: Placebo cohort 2
- Group 5: Sildenafil cohort 3
- Group 6: Sildenafil cohort 2
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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