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

University Hospital, Bonn2 sites in 1 country98 target enrollmentJanuary 2007

ConditionsDiaphragmatic Hernia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diaphragmatic Hernia
Sponsor: University Hospital, Bonn
Enrollment: 98
Locations: 2
Primary Endpoint: Survival to discharge from hospital
Status: Withdrawn
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

January 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Factorial

Sex

Female

Investigators

Sponsor

University Hospital, Bonn

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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