Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
This study is looking at a treatment called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies with a severe condition called Congenital Diaphragmatic Hernia (CDH). CDH means there's a hole in the baby's diaphragm, which can stop their lungs from growing properly. FETO involves placing a small balloon in the baby's windpipe while still in the womb to help the lungs grow. Researchers want to see if this treatment can be successfully used in babies with very severe left-sided CDH, specifically those with a lung-to-head ratio (O/E LHR) less than 25%. The main goal is to see how many babies survive and are discharged from the hospital, which is expected to be around 12 weeks after birth. This study is for pregnant women aged 18 or older with a single baby diagnosed with isolated left CDH, liver in the chest, and severe lung underdevelopment, before 29 weeks and 6 days of pregnancy. The current status of this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 15 participants. It is designed to test the feasibility of implementing FETO therapy.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed until the baby is discharged from the hospital, which is expected to be an average of 12 weeks.
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Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Timothy Crombleholme, MD · PRINCIPAL_INVESTIGATOR · Connecticut Children's Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Percent of neonatal survivors at time of dischargeDischarge from the hospital, an expected average of 12 weeks.
Feasibility, safety, and survival rates of the FETO procedure