Pilot Study of Fetoscopic Endoluminal Tracheal Occlusion to Treat Severe Left Congenital Diaphragmatic Hernia in Pregnant Women

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion FETO for fetuses diagnosed with severe left congenital diaphragmatic hernia CDH. This research is conducted at Mayo Clinic and aims to improve lung development in affected fetuses by using a special balloon device. The study focuses on a specific group of pregnant women carrying single fetuses with severe lung underdevelopment as measured by ultrasound lung-to-head ratio. Participants will undergo the FETO procedure between 27 weeks 0 days and 29 weeks 6 days of pregnancy. This involves placing a detachable latex balloon inside the fetal trachea using a fetoscopic device inserted through the mothers abdomen and uterus. The balloon is inflated to block the trachea, which is intended to help promote lung growth. The study tracks the success of balloon placement and removal, surgery times, and any unplanned balloon removals or maternal complications. During the study, researchers will monitor the pregnancy until delivery and assess various outcomes including gestational age at delivery and maternal complications. After birth, infants will be followed up to 24 months to measure lung growth, survival, oxygen dependency, complications, and time spent in neonatal intensive care or on ventilators. Maternal hospitalization and delivery methods are also recorded. Participants will need to comply with follow-up requirements and live near Mayo Clinic during the pregnancy for close monitoring.

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia