The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic Hernia (CDH).
This is an un-blinded, non-randomized, double-arm phase III clinical trial designed to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion in cases of severe Congenital Diaphragmatic Hernia (CDH) and intrathoracic liver herniation. Patients in the intervention arm will undergo balloon insertion into the fetal trachea between 27 and 30 weeks of gestation. Fetoscopic removal of the balloon occlusion will be performed at 34 weeks gestation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
FETO procedure involves insertion of a balloon into the fetal trachea under IV sedation with local anesthesia or combined spinal-epidural anesthesia. Balloon removal will take place up to 7 weeks after insertion.
Oregon Health & Science University
Portland, Oregon, United States
Outcomes of placement and removal of FETO device
Whether placement and removal of the FETO device was successful or not
Time frame: Device placement will take place between 27 weeks 0 days and 29 weeks 6 days gestation. Removal will take place between 34 weeks 0 days and 34 weeks 6 days.
Compare survival to discharge between FETO and expectant management
Evaluate rates of survival to discharge from the neonatal intensive care units (NICU) between fetuses treated with the FETO and those undergoing expectant management
Time frame: Evaluated upon discharge from the NICU (typically 6 months to 1 year after birth)
FETO Complications
Evaluate the frequency of maternal and fetal complications associated with the FETO procedure
Time frame: Information about adverse events and complications will take place from study enrollment (gestational age less than 29 weeks) to study conclusion (24 months post-birth)
Long-term mortality and morbidities
Comparison of rates of long-term mortality and morbidities compared between FETO group and those who underwent expectant management.
Time frame: 6 months, 12 months, 18 months, and 24 months of age
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