Actively Recruiting
A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)
Led by University of Utah · Updated on 2025-04-04
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of sildenafil therapy for pulmonary hypertension (PH) in newborns with congenital diaphragmatic hernia (CDH). CDH is a condition where a defect in the diaphragm allows abdominal organs to move into the chest, affecting lung growth and leading to respiratory failure and PH after surgical repair. This trial aims to better understand how sildenafil, a drug that relaxes blood vessels in the lungs, may help improve heart and lung function in these infants. The study compares two groups: one receiving sildenafil citrate orally at 1mg/kg every 8 hours for up to 14 days, and the other receiving a placebo with the same schedule. Sildenafil works by increasing levels of cGMP in lung vessels to relax them and reduce PH. Treatment starts after surgical repair and an echocardiogram showing elevated left ventricular eccentricity index (LVEI) of 1.4 or higher. The trial uses a randomized, quadruple-masked design to fairly assess the effects. Participants will have echocardiograms before starting treatment and after 14 days to measure changes in LVEI, an indicator of pulmonary hypertension. Researchers will also monitor the need for extracorporeal membrane oxygenation (ECMO), death rates, use of other lung medications, and side effects like low blood pressure or reduced urine output. The study aims to support future larger trials focused on long-term heart and lung health in infants with CDH and PH.
CONDITIONS
Brief Title
A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 14 days
Participants receive either sildenafil or placebo to treat pulmonary hypertension after surgical repair of congenital diaphragmatic hernia.
Multiple visits during treatment for dosing and monitoring
Trial Site Locations
Total: 1 location
1
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
Research Team
C
Carrie A Rau, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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