Status:
WITHDRAWN
Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
Lead Sponsor:
University Hospital, Bonn
Collaborating Sponsors:
Universitätsmedizin Mannheim
Conditions:
Diaphragmatic Hernia
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
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 fetos...
Eligibility Criteria
Inclusion
- Pregnant women from European countries carrying fetuses with congenital right or left diaphragmatic hernias
- Normal karyotype, no further severe anomalies on prenatal ultrasound study
- Fetal liver herniation into the chest, Lung-to-head ratio of ≥0,40 ≤0,84 between 30+0 - 33+5 weeks+days of gestation
Exclusion
- Any maternal disease or condition that would result in an increased risk to her personal health from the experimental procedure
- Abnormal fetal karyotype
- Further severe fetal anomalies on prenatal ultrasound
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00373763
Start Date
January 1 2007
Last Update
August 25 2008
Active Locations (2)
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1
German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn
Bonn, Germany, 53105
2
Neonatal Intensive Care Unit (ECMO center), University of Mannheim
Mannheim, Germany, 68167