The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Fetal endoscopic tracheal occlusion (FETO) is a procedure where a balloon is placed in the main airway or "windpipe" of the fetus, to help with the development of the lungs. This is performed using a fetoscope, a small camera that is inserted into the amniotic cavity and deploying the FETO Goldballoon into the fetal trachea.
Lucile Packard Children's Hospital
Stanford, California, United States
RECRUITINGNumber of neonates who survive until initial hospital discharge
Time frame: Average approximately 6 months (up to 1 year)
Number of neonates who survive until 28 days of life
Time frame: 28 days
Number of children who survive until 6 months of age
Time frame: 6 months
Number of children who survive until 1 year of age
Time frame: 1 year
Number of children who survive until 2 years of age
Time frame: 2 years
Number of children who receive extracorporeal membrane oxygenation (ECMO)
Time frame: Average approximately 6 months (up to 1 year)
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