Safety and Efficacy of FETO in CDH Phase III
Children's Hospital Medical Center, Cincinnati
Summary
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group
Description
The purpose of this study is to demonstrate that the FETO procedure increases the neonatal survival to discharge and reduces long-term morbidity rates in fetuses found to have intrathoracic herniation of the liver with LCDH and o/e LHR \< 30% or RCDH and o/e LHR \< 45 % with intrathoracic liver herniation when compared to those that receive standard of care management that have comparable defects for side and fetal lung volumes estimates and intrathoracic liver herniation.
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- Yes
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 \…
Interventions
- DeviceFETO, Fetal Endoluminal Tracheal Occlusion
Fetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia
Location
- Cincinnati Children's Hospital Medical Center (CCHMC)Cincinnati, Ohio