NCT00373763

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: University Hospital, Bonn · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diaphragmatic Hernia

Interventions

Type	Name	Description
PROCEDURE	Fetoscopic tracheal balloon occlusion

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-01-01
• First posted: 2006-09-08
• Last updated: 2008-08-25

Locations

2 sites across 1 country: Germany