Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial
Dr Erin Perrone
Summary
The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that elect not to have the FETO procedure performed during pregnancy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
FETO Intervention Arm: Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study * Pregnant women, age 18 years and older * Singleton pregnancy * Normal fetal karyotype, Chromosomal Microarray (CMA) with non-pathologic variants, Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS). Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \>26 weeks. * Gestational age at enrollment prior to 29w6d *…
Interventions
- DeviceFETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.
Location
- University of MichiganAnn Arbor, Michigan