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

Not Applicable

Withdrawn

• Conditions: Diaphragmatic Hernia

• Registration Number: NCT00373763
• Lead Sponsor: University Hospital, Bonn

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-06
• Study First Posted: 2006-09-08
• Study Start: 2007-01
• Primary Completion: 2008-01
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-22
• Last Update Posted: 2008-08-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Survival to discharge from hospital

Secondary Outcome Measures

Name	Time	Method
Maternal morbidity
Fetal morbidity
Premature preterm rupture of membranes
Unintended preterm delivery
Conventional ventilation strategies possible
ECMO required
Days in intensive care
Days in hospital
Oxygen dependency on discharge

Trial Locations

Locations (2)

German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn; 🇩🇪 Bonn, Germany

Neonatal Intensive Care Unit (ECMO center), University of Mannheim; 🇩🇪 Mannheim, Germany