NCT06884423 Safety and Efficacy of FETO in CDH: A Phase III Trial

Trial Parameters

Eligibility Fast-Check

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Brief Summary

Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.

Eligibility Criteria

Inclusion Criteria: 1. Pregnant women age 18 years and older 2. Singleton pregnancy 3. Normal fetal karyotype with confirmation by culture results, whole exome sequencing (WES), whole genome sequencing (WGS), or chromosomal microarray with non-pathologic variants. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 26 weeks. 4. Gestational age at enrollment is prior to 29 weeks 6 days 5. Liver is intrathoracic 6. Isolated left congenital diaphragmatic hernia (CDH) with observed/expected lung to head ratio (O/E LHR) of less than 30% at enrollment (18\^0 to 29\^5 weeks), or: 7. Isolated right CDH with O/E LHR equal to or less than 45% at enrollment (18\^0 to 29\^5 weeks). 8. Cervical length by transvaginal ultrasound equal to or greater than 20 mm within 24 hours of fetoscopic endoluminal tracheal occlusion (FETO) procedure 9. Patient meets psychosocial criteria 10. Informed consent Exclusion Criteria: 1. Patient is less than 18 years of

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