Clinical Trial: Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Randomized Clinical Trial for the Assessment of the Life-Saving Potential of Fetoscopic Tracheal Balloon Occlusion in Fetuses With Severe Congenital Diaphragmatic Hernia -
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 Summary:
Sponsor: University Hospital, Bonn
Current Primary Outcome: Survival to discharge from hospital
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: University Hospital, Bonn
Dates:
Date Received: September 6, 2006
Date Started: January 2007
Date Completion:
Last Updated: August 22, 2008
Last Verified: August 2008
