NCT07187206 Safety and Efficacy of FETO in CDH Phase III
| NCT ID | NCT07187206 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Congenital Diaphragmatic Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2032-12-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group
Eligibility Criteria
Inclusion Criteria: * Pregnant women 18 years and older, who are able to consent * Singleton pregnancy * Gestational age at enrollment is prior to 296 weeks * Intrathoracic liver herniation * Isolated Left CDH with o/e LHR \< 30% at enrollment (180 to 295 weeks) or * Isolated Right CDH with o/e LHR \< 45% at enrollment (180 to 295 weeks) * Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks * Cervical length by transvaginal ultrasound \> 20 mm within 24 hours prior to FETO procedure * Patient meets psychosocial criteria * Informed consent understood Exclusion Criteria * Patient \< 18 years of age * Multi-fetal pregnancy * History of natural rubber latex allergy * Preterm labor, cervix shortened (\< 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or