FETO balloon procedure for severe congenital diaphragmatic hernia
Part of Genetic & congenital, Heart & circulation, Lungs & breathing clinical trials.
This trial studies a fetal procedure called FETO (placing a small balloon in the baby’s windpipe) to help severe congenital diaphragmatic hernia babies develop better lungs before birth. It may help some babies whose scans suggest very limited lung growth, but it requires specific timing and pregnancy conditions.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must have an isolated congenital diaphragmatic hernia (CDH) with the liver sitting higher than usual (“liver-up”).
- The baby’s lung development on ultrasound must be very limited (measured by LHR below set cutoffs) and match the specific timing windows for the procedure.
- You must be at least 18 years old, and you must be able to have the procedure within the listed weeks of pregnancy.
- Your pregnancy must be a single baby (not twins or more).
- You must have normal chromosome testing (karyotype or FISH) and a normal fetal echocardiogram (no major heart issues).
- Your family must be able to stay in the Cincinnati area for the rest of the pregnancy and meet psychosocial requirements; you must also have declined pregnancy termination at less than 24 weeks.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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This trial tests if a special surgery (FETO) done while the baby is still in the womb can improve survival for babies with a severe form of congenital diaphragmatic hernia (CDH). The surgery places a small balloon in the baby's windpipe to help the lungs grow. We are looking for pregnant women whose baby has a left-sided CDH with a lung-to-head ratio (LHR) less than 30%, or a right-sided CDH with LHR less than 45%, and whose liver is herniated into the chest.
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This trial studies a specialized pregnancy procedure (FETO) done to help babies with a defect in the diaphragm called congenital diaphragmatic hernia (CDH) grow better lungs before birth. It may help by improving lung development, based on how severe the baby’s lung underdevelopment looks on ultrasound, and it requires close follow-up at the study hospital.
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This trial tests a procedure called FETO (fetoscopic endoluminal tracheal occlusion) performed during pregnancy to help babies with congenital diaphragmatic hernia—a birth defect where part of the diaphragm (breathing muscle) has a hole and organs from the belly move into the chest. The procedure temporarily blocks the baby's windpipe to help the lungs grow bigger before birth.
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