NCT05201144View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 15, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

September 30, 2026

Conditions
Congenital Diaphragmatic HerniaPulmonary Hypertension
Interventions
DRUG

Sildenafil Oral Suspension

Sildenafil citrate is a highly selective PDE-5 inhibitor found in pulmonary vascular smooth muscle cells. Sildenafil acts by increasing cGMP levels in the nitric oxide pathway, leading to smooth muscle relaxation and an anti-proliferative effect within the pulmonary vasculature.

OTHER

Placebo

Equal volume of placebo

Trial Locations (1)

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

All Listed Sponsors
lead

University of Utah

OTHER