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| ID | Type | Description | Link |
|---|---|---|---|
| 093/06 |
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No patients could be recruited and randomized due to other center offering backdoor for treatment.
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| Name | Class |
|---|---|
| Universitätsmedizin Mannheim | OTHER |
Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Therefore, the purpose of this randomized clinical trial is to provide further evidence about the efficacy and safety of the prenatal interventional approach. Primary outcome measure is postnatal survival to discharge from hospital treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetoscopic tracheal balloon occlusion | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Survival to discharge from hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal morbidity | ||
| Fetal morbidity | ||
| Premature preterm rupture of membranes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Kohl, MD | German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany | Principal Investigator |
| Thomas Schaible, MD | Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn | Bonn | 53105 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16601345 | Background | Kohl T, Gembruch U, Filsinger B, Hering R, Bruhn J, Tchatcheva K, Aryee S, Franz A, Heep A, Muller A, Bartmann P, Loff S, Hosie S, Neff W, Schaible T; German Center for Fetal Surgery Diaphragmatic Hernia Task Group. Encouraging early clinical experience with deliberately delayed temporary fetoscopic tracheal occlusion for the prenatal treatment of life-threatening right and left congenital diaphragmatic hernias. Fetal Diagn Ther. 2006;21(3):314-8. doi: 10.1159/000091363. |
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| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D065630 | Hernias, Diaphragmatic, Congenital |
| ID | Term |
|---|---|
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unintended preterm delivery |
| Conventional ventilation strategies possible |
| ECMO required |
| Days in intensive care |
| Days in hospital |
| Oxygen dependency on discharge |
| Neonatal Intensive Care Unit (ECMO center), University of Mannheim |
| Mannheim |
| 68167 |
| Germany |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |