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

Launched by UNIVERSITY OF UTAH · Jan 7, 2022

Keywords

ClinConnect Summary

The TOP-CDH clinical trial is studying the use of a medication called sildenafil to help treat pulmonary hypertension (PH) in newborns with a condition known as congenital diaphragmatic hernia (CDH). CDH is a birth defect that affects how the diaphragm forms, which can lead to problems with lung growth and breathing after surgery. This trial aims to find out if sildenafil is safe and effective for these infants, especially since many babies with CDH experience PH after their surgery, but there hasn’t been a standard way to treat it.

To be eligible for this trial, infants need to be admitted to the Neonatal Intensive Care Unit (NICU) at Primary Children's Hospital, have CDH, and have undergone surgery to repair the diaphragmatic defect. They must also have a specific heart test (echocardiogram) showing a certain result within a few days after surgery. If parents choose to participate, they can expect close monitoring while their child receives sildenafil, and the information gathered will help guide future research on treating PH in these vulnerable infants.

Gender

ALL

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 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