Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I

University Hospital Bonn (UKB)

Status

Withdrawn

Conditions

Diaphragmatic Hernia

Treatments

Procedure: Fetoscopic tracheal balloon occlusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00373763

093/06

DH-EUROTRIAL I - 093/06

Details and patient eligibility

About

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.

Enrollment

98 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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