Status:
UNKNOWN
FETO With Long Tail Balloon for a Treatment of Severe CDH
Lead Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Conditions:
Severe Congenital Diaphragmatic Hernia
Eligibility:
FEMALE
18-48 years
Phase:
NA
Brief Summary
Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns. The survival rate depends on the extent of the lung hypoplasia and pulmonary hypertension. In case of an observed /...
Detailed Description
Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns, depending on whether stillbirths are included or not. 40 % of all CDH cases show associated malformations and chrom...
Eligibility Criteria
Inclusion
- maternal age of 18-48 years
- severe CDH with MRI measured observed/expected total fetal lung volume (o/e TFLV) \< 25% or \< 35% in combination with a liver herniation into the thorax.
Exclusion
- fetuses with other letal morphological abnormalities
- fetuses with chromosomal abnormalities
- severe maternal illneses
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03431792
Start Date
August 30 2017
End Date
August 30 2021
Last Update
February 13 2018
Active Locations (1)
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1
Center of Fetal Surgery, Clinic of Obstetrics and Perinatal Medicine, Martin-Luther-University Halle-Wittenberg
Halle, Germany, 06120