Stopped: The investigators are withdrawing this pilot FETO study, and are now working to plan a larger phase III FETO trial. The investigators will be posting details about the new FETO study soon.
The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth. This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Successful Ballon Placement
Timeframe: Gestational age of 27 weeks 0 days to 29 weeks 6 days
Successful Balloon Removal
Timeframe: Prior to delivery, ideally at 34 weeks
Balloon placement operative time
Timeframe: Gestational age of 27 weeks 0 days to 29 weeks 6 days
Balloon removal operative time
Timeframe: Prior to delivery, ideally at 34 weeks
Type of FETO release
Timeframe: Prior to delivery, ideally at 34 weeks
Maternal Complications
Timeframe: From balloon placement to delivery
Gestational age at delivery
Timeframe: At delivery