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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fetal Endoscopic Tracheal Occlusion (FETO) | Experimental | FETO is performed in-utero and the balloon is removed prior to delivery, and children will have follow-up visits until the age of 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balt "Goldballoon" | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of neonates who survive until initial hospital discharge | Average approximately 6 months (up to 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of neonates who survive until 28 days of life | 28 days | |
| Number of children who survive until 6 months of age | 6 months | |
| Number of children who survive until 1 year of age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yair Blumenfeld, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital | Recruiting | Stanford | California | 94305-6070 | United States |
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| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
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|
| 1 year |
| Number of children who survive until 2 years of age | 2 years |
| Number of children who receive extracorporeal membrane oxygenation (ECMO) | Average approximately 6 months (up to 1 year) |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |