NCT00373438

Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

Randomized Clinical Trial in Order to Assess the Effect of Fetoscopic Tracheal Balloon Occlusion on the Postnatal Disease Course in Neonates With Left Congenital Diaphragmatic Hernia - FDH-ECMO/BALLOON-TRIAL

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: University Hospital, Bonn · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants. 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 in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.

Conditions

• Diaphragmatic Hernia

Interventions

Type	Name	Description
PROCEDURE	Fetoscopic tracheal balloon occlusion	Maternal local anesthesia, percutaneous ultrasound-guided fetal analgo-sedation and relaxation, percutaneous ultrasound-guided access into amniotic cavity with trocar, fetoscopic tracheal ballon occlusion, removal of fetoscope and trocar, maternal abdominal closure, skin-to-skin time 30 minutes

Timeline

• Start date: 2009-01-01
• Primary completion: 2014-01-01
• Completion: 2014-07-01
• First posted: 2006-09-08
• Last updated: 2009-01-06

Locations

1 site across 1 country: Germany