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Sildenafil for Bronchopulmonary Dysplasia (SILDI-SAFE Trial)
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.
SILDI-SAFE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSILDI-SAFE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SILDI-SAFE Trial Design
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Who is running the clinical trial?
Media Library
- I have not taken milrinone in the last 24 hours.I have sickle cell disease.I have not used inhaled nitric oxide in the last 24 hours.I am on a breathing machine or CPAP depending on my baby's age in weeks.I was born before reaching 29 weeks of pregnancy.You use any of these breathing devices: Nasal cannula with more than 2 liters per minute, Nasal continuous positive airway pressure (NCPAP), Nasal intermittent positive pressure ventilation (NIPPV), Noninvasive neurally adjusted ventilatory assist (NAVA), or any other device that gives positive pressure through the nose.I haven't taken any vasopressor medications in the last 24 hours.My baby is between 32 and 44 weeks in developmental age.I had surgery or needed treatment for a heart defect I was born with.I was previously enrolled and received treatment in the NHLBI-2019-SIL study for severe BPD.Your AST levels are too high within 72 hours before the study starts.You are allergic to sildenafil.Your recent echocardiogram shows signs of a heart or lung condition.Your alanine aminotransferase (ALT) levels are too high within 72 hours before starting the study.I have not taken sildenafil in the last 7 days.
- 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.
- Group 1: Cohort 3, sildenafil
- Group 2: Cohort 1, sildenafil
- Group 3: Cohort 2, placebo
- Group 4: Cohort 3, placebo
- Group 5: Cohort 1, placebo
- Group 6: Cohort 2, sildenafil
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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