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New treatment option for Congenital Diaphragmatic Hernia
Official title A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)
ClinicalTrials.gov ID: NCT05201144
What this study is testing
What is Sildenafil Oral Suspension?
Sildenafil Oral Suspension is an investigational medicine, being studied as a potential treatment for congenital diaphragmatic hernia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Congenital diaphragmatic hernia (CDH) occurs in approximately 1 in 3000 US live births, similar to the incidence seen within the Utah Birth Defects cohort. The diaphragmatic defect compromises lung growth and alters pulmonary vascular development.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Infants admitted to PCH NICU
- Diagnosis of congenital diaphragmatic hernia (CDH)
- Status post-surgical repair of diaphragmatic defect
- Has an echocardiogram 48-72 hours after repair with left ventricular eccentricity index (LVEI) ≥ 1.4
- Parental consent obtained within 24 hours after the above echocardiogram
You likely can't join if
- Infants with CDH who do not undergo surgical repair
- Does not have an echocardiogram 48-72 hours post-repair
- Has LVEI \< 1.4 on above echocardiogram
- Has concurrent severe congenital heart defect that requires neonatal cardiac repair
- Has a documented sildenafil allergy
- Concurrent therapy with fluconazole at time of study drug initiation
See the full eligibility criteria
- Infants admitted to PCH NICU
- Diagnosis of congenital diaphragmatic hernia (CDH)
- Status post-surgical repair of diaphragmatic defect
- Has an echocardiogram 48-72 hours after repair with left ventricular eccentricity index (LVEI) ≥ 1.4
- Parental consent obtained within 24 hours after the above echocardiogram
- Infants with CDH who do not undergo surgical repair
- Does not have an echocardiogram 48-72 hours post-repair
- Has LVEI \< 1.4 on above echocardiogram
- Has concurrent severe congenital heart defect that requires neonatal cardiac repair
- Has a documented sildenafil allergy
- Concurrent therapy with fluconazole at time of study drug initiation
- Inability to obtain parental consent within 24 hours of the echocardiogram
- Receiving extracorporeal membrane oxygenation (ECMO) at the time of the study
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.