Study of Sildenafil Treatment for Pulmonary Hypertension in Newborns with Congenital Diaphragmatic Hernia After Surgery

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 1mgkg 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.

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