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| ID | Type | Description | Link |
|---|---|---|---|
| 135/06 |
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| Name | Class |
|---|---|
| Universitätsmedizin Mannheim | OTHER |
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Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants.
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 in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | No Intervention |
| |
| B | Experimental | Fetoscopic tracheal occlusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetoscopic tracheal balloon occlusion | Procedure | Maternal local anesthesia, percutaneous ultrasound-guided fetal analgo-sedation and relaxation, percutaneous ultrasound-guided access into amniotic cavity with trocar, fetoscopic tracheal ballon occlusion, removal of fetoscope and trocar, maternal abdominal closure, skin-to-skin time 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Need for postnatal ECMO therapy | First two days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Survival to discharge from hospital | Days to discharge | |
| Maternal morbidity | Until maternal discharge | |
| Fetal / Neonatal morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Kohl, MD | Contact | -49-228-2871-5942 | thomas.kohl@ukb.uni-bonn.de | |
| Thomas Schaible, MD | Contact | -49-160-550-1023 | t.schaible@t-online.de |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Center for Fetal Surgery & Minimally Invasive Therapy | Recruiting | 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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|
| Overall & at discharge from hospital |
| Premature preterm rupture of membranes | Following the interventions over the remainder of gestation |
| Unintended preterm delivery | Following the interventions before scheduled elective delivery |
| Days in intensive care | Number of day until discharge from ICU |
| Days in hospital | Number of days until discharge from hospital |
| Oxygen dependency on discharge | Days until discharge |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |