Trial of Fetal Endoscopic Tracheal Occlusion Using Goldballoon Balloon for Severe Congenital Diaphragmatic Hernia in Pregnant Women

What this Trial Is About

Researchers are evaluating the feasibility and safety of treating severe Congenital Diaphragmatic Hernia CDH in unborn babies using a procedure called Fetal Endoscopic Tracheal Occlusion FETO with a Goldballoon Detachable Balloon GOLDBAL2 and a Delivery Microcatheter. This pilot trial is conducted at a single center and focuses on pregnant women whose fetuses have severe lung underdevelopment due to CDH. The study aims to understand how well the balloon placement and removal work within specific gestational ages and to assess related health outcomes for mother and baby. The treatment involves placing a balloon in the fetal airway between 27 weeks 0 days and 29 weeks 6 days of pregnancy. The balloon is ideally removed between 34 weeks 0 days and 34 weeks 6 days, with timing decided by the fetal treatment team. Participants must live close to the study center to attend weekly follow-ups while the balloon is in place and until delivery. The procedure restricts normal daily activities such as exercise, sexual intercourse, and working during the remainder of the pregnancy. A support person must be available to stay with the participant. During the trial, researchers will monitor the success of balloon placement and removal, changes in fetal lung size through MRI scans, gestational age at delivery, survival of the infant up to hospital discharge or 180 days, and any maternal complications up to 4 to 6 weeks after birth. Weekly visits and close follow-up will help track these outcomes. The total study duration includes the pregnancy period from balloon placement through delivery and postpartum monitoring.

Fetal Endoscopic Tracheal Occlusion for CDH (CDH)