Sildenafil for Neonatal Congenital Diaphragmatic Hernia
A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)
Recruiting
Phase 2
Interventional Study
Congenital Diaphragmatic Hernia
Pulmonary Hypertension
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- University of Utah · Other
Who this trial is looking for
This trial is looking for infants with congenital diaphragmatic hernia who have had surgery to repair the condition. Participating involves getting consent from parents and undergoing an echocardiogram to assess heart function after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
- I am an infant admitted to the Primary Children's Hospital NICU.
- I have been diagnosed with congenital diaphragmatic hernia.
- I have had surgical repair of the diaphragmatic defect.
- I have had an echocardiogram 48-72 hours after the repair.
- My echocardiogram shows a left ventricular eccentricity index (LVEI) of 1.4 or higher.
- My parents have given consent within 24 hours after the echocardiogram.
You may not be able to join if
- I have congenital diaphragmatic hernia but did not have surgical repair.
- I did not have an echocardiogram 48-72 hours after the repair.
- My echocardiogram shows an LVEI of less than 1.4.
- I have a severe congenital heart defect that needs repair.
- I am allergic to sildenafil.
- I am being treated with fluconazole at the time of starting the study drug.
- My parents cannot provide consent within 24 hours of the echocardiogram.
- I am on extracorporeal membrane oxygenation (ECMO) at the time of the study.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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. Cur…
Trial Locations
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Eligibility Criteria
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 …
Contacts