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Sponsors and Collaborators: |
University Hospital, Bonn University Hospital Mannheim |
Information provided by: | University Hospital, Bonn |
ClinicalTrials.gov Identifier: | NCT00373763 |
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.
Condition | Intervention |
Diaphragmatic Hernia |
Procedure: Fetoscopic tracheal balloon occlusion |
MedlinePlus related topics: | Hernia |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Randomized Clinical Trial for the Assessment of the Life-Saving Potential of Fetoscopic Tracheal Balloon Occlusion in Fetuses With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I |
Estimated Enrollment: | 98 |
Study Start Date: | January 2007 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn | |||||
Bonn, Germany, 53105 | |||||
Neonatal Intensive Care Unit (ECMO center), University of Mannheim | |||||
Mannheim, Germany, 68167 |
University Hospital, Bonn |
University Hospital Mannheim |
Principal Investigator: | 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 |
Homepage of the German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany 
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Responsible Party: | German Center for Fetal Surgery & Minimally-Invasive Therapy ( Thomas Kohl MD ) |
Study ID Numbers: | DH-EUROTRIAL I - 093/06, 093/06 |
First Received: | September 6, 2006 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00373763 |
Health Authority: | Germany: Ethics Commission |
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