Status:
UNKNOWN
Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia
Lead Sponsor:
University Hospital, Bonn
Collaborating Sponsors:
Universitätsmedizin Mannheim
Conditions:
Diaphragmatic Hernia
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
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 ox...
Eligibility Criteria
Inclusion
- Pregnant women from European countries carrying fetuses with left diaphragmatic hernia.
- Normal karyotype, no further severe anomalies on prenatal ultrasound study.
- Fetal liver herniation into the chest; gestational age-related lung volume between 20-25% of normal as determined by magnetic resonance imaging between 30+0 - 34+0 weeks+days of gestation.
Exclusion
- Any maternal disease or condition that would result in an increased risk to her health from the experimental procedure.
- Abnormal fetal karyotype, further severe fetal anomalies on prenatal ultrasound.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00373438
Start Date
January 1 2009
End Date
July 1 2014
Last Update
January 6 2009
Active Locations (1)
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1
German Center for Fetal Surgery & Minimally Invasive Therapy
Bonn, Germany, 53105