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The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients) will determine the feasibility of UTHealth's future participation in multi-center trials of this intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FETO therapy | Experimental | Intervention name: FETO therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FETO therapy | Device | Fetoscopic surgery at 27 to 31 weeks and 6 days gestation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful placement of Balt Goldbal2 balloon | 7 weeks after placement | |
| Successful removal of Balt Goldbal2 balloon | within 5 weeks prior to delivery | |
| Gestational age at delivery | at delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Lung volume | 7 weeks after placement of balloon | |
| Lung head ratio | 7 weeks after placement of balloon | |
| Survival at 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal complications | Maternal complications include preterm labor, premature preterm rupture of membranes, oligohydramnios, polyhydramnios, and chorioamnionitis. | After Insertion of Balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Johnson, DO | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | 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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| 30 days post delivery |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |