Using Sildenafil to Treat Neonates with Congenital Diaphragmatic Hernia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of sildenafil citrate, a phosphodiesterase-5 inhibitor, in neonates diagnosed with congenital diaphragmatic hernia (CDH) who have undergone surgical repair. The study aims to assess the drug's effectiveness in managing pulmonary hypertension (PH) that often complicates recovery in these infants. Participants will receive either sildenafil or a placebo, and their responses will be monitored through echocardiograms to evaluate pulmonary vascular function. The trial is conducted at Primary Children's Hospital in Salt Lake City, Utah, focusing on improving outcomes for this vulnerable population.

Why it matters

Who can join: the full rules

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

Where it's running

• Primary Children's Hospital
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Carrie A Rau, RN
• Email: carrie.rau@hsc.utah.edu
• Phone: 801-213-3360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.