North American Study on Long-Term Outcomes of Fetoscopic Endoluminal Tracheal Occlusion FETO in Severe Left and Right Congenital Diaphragmatic Hernia

What this Trial Is About

Researchers are studying Fetoscopic Endoluminal Tracheal Occlusion FETO to improve survival and reduce long-term health problems in fetuses with severe isolated congenital diaphragmatic hernia CDH. This study focuses on fetuses with left CDH and very low lung size or right CDH with moderate lung size, all with liver herniation into the chest. They plan to enroll 80 pregnant women and follow their children for up to 24 months to compare outcomes between those receiving FETO and those receiving standard care. Participants in the FETO group will undergo a two-step procedure between 27 and 30 weeks of pregnancy first, a balloon is inserted into the fetal windpipe, then removed around 34 weeks. The planned delivery happens after 37 weeks. The control group will receive standard care without the FETO procedure. After birth, children will be monitored for two years to track survival, lung health, infections, growth, and neurological development. Throughout the study, participants will have regular ultrasounds and clinical visits to monitor pregnancy and fetal health. Researchers will collect data on procedure success, complications, survival rates at birth and over two years, and various health issues such as lung hypertension, infections, brain injuries, and growth. This comprehensive monitoring aims to understand the benefits and risks of FETO compared to standard care for severe CDH cases.

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH