FETO balloon treatment for severe birth diaphragm hernia
Part of Genetic & congenital clinical trials.
This trial tests a special pregnancy procedure called FETO to help babies born with severe congenital diaphragm hernia (CDH) breathe better after birth. It may help by improving lung growth, but it requires close follow-up at a Chicago fetal center.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are pregnant, age 18 or older, and carrying one baby (singleton pregnancy)
- Ultrasound suggests your baby has isolated severe left CDH (LHR ≤ 25%) or isolated severe right CDH (LHR ≤ 35%) with the liver moved up
- Your baby must have the FETO balloon procedure planned between 27 weeks 0 days and 29 weeks 6 days
- Prenatal genetic/chromosome testing is normal (no disease-causing changes on microarray or karyotype; if using FISH it must be after 26 weeks)
- You can travel to and stay near the Chicago Institute for Fetal Health during the time between placement and removal, and attend follow-ups with a support person nearby
- You can receive fetoscopic surgery safely (no major maternal medical problems/contraindications) and meet study lifestyle and psychosocial rules
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 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.
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.
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.
This trial studies a fetal procedure called FETO that places a small balloon in the baby’s windpipe to help the lungs grow in severe congenital diaphragmatic hernia (CDH). It may help babies with very small lung development after birth, but you must meet specific pregnancy, genetic, and safety requirements.
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.
This trial tests if placing a temporary balloon in the baby's windpipe before birth can improve survival for babies with a severe form of a diaphragmatic hernia. It is for pregnant women carrying a single baby with a left-sided hernia that is more severe or a right-sided hernia, and whose liver is up in the chest.
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