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A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)

RecruitingPhase 2Ages any - anyAllUniversity of Utah
NCT05201144 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. This is reflected postnatally as respiratory failure, pulmonary hypertension (PH) and overall cardiopulmonary dysfunction, particularly post-repair. Currently, optimal management of post-repair PH remains poorly investigated. Sildenafil citrate is a highly selective phosphodiesterase-5 inhibitor that increases cGMP levels, leading to smooth muscle relaxation and an anti-proliferative effect within the pulmonary vasculature. It is used off-label for many neonatal PH disorders, including PH associated with bronchopulmonary dysplasia and idiopathic persistent PH. Most neonates with CDH born within the Mountain West referral basin are managed at a

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📋 Eligibility rules (as published)
Inclusion 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 Exclusion Criteria: * 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
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What it tests

  • Sildenafil Oral Suspension
  • Placebo
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Where

1 site
Primary Children's Hospital
Salt Lake City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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