Status:
RECRUITING
A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)
Lead Sponsor:
University of Utah
Conditions:
Congenital Diaphragmatic Hernia
Pulmonary Hypertension
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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 gr...
Detailed Description
Congenital diaphragmatic hernia (CDH) occurs in approximately 1 in 3000 US live births, similar to the incidence seen within the Utah Birth Defects cohort. An early developmental diaphragmatic defect ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05201144
Start Date
September 15 2022
End Date
September 30 2026
Last Update
April 4 2025
Active Locations (1)
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1
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113