Study of Fetal Endoscopic Tracheal Occlusion FETO Using the Balt Goldballoon to Treat Severe Congenital Diaphragmatic Hernia in Pregnant Women Aged 18 to 50

What this Trial Is About

This research aims to evaluate the effectiveness of fetal endoscopic tracheal occlusion FETO for treating severe congenital diaphragmatic hernia CDH diagnosed before birth. The study also collects safety and effectiveness data for the off-label use of the FETO Goldballoon device, which is inserted into the fetal windpipe to support lung development. The trial is conducted at an advanced medical center with specialized maternal-fetal medicine, neonatal care, and pediatric surgery services. The treatment involves placing a balloon inside the fetuss trachea using a fetoscope, a small camera inserted into the amniotic cavity. This balloon is removed before delivery. After birth, children will have follow-up visits until they reach 2 years of age. The study focuses on cases of severe left or right-sided CDH and involves close multidisciplinary counseling and planning for delivery at the study hospital. Participants will be monitored through their pregnancy and after birth with assessments including survival rates at various milestones up to 2 years of age and the need for extracorporeal membrane oxygenation ECMO. The primary outcome is the number of newborns who survive until initial hospital discharge, typically about 6 months. The study requires participants to remain near the hospital during balloon placement and includes thorough genetic and ultrasound screenings to confirm eligibility.

Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia