Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

Phase 2

• Conditions: Diaphragmatic Hernia
• Interventions: Procedure: Fetoscopic tracheal balloon occlusion

• Registration Number: NCT00373438
• Lead Sponsor: University Hospital, Bonn

Brief 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.

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
• Status Verified: 2009-01
• Study Start: 2009-01
• Last Update Submitted: 2009-01-05
• Last Update Posted: 2009-01-06
• Primary Completion: 2014-01
• Study Completion: 2014-07

Recruitment & Eligibility

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

Inclusion Criteria

• Pregnant women from European countries carrying fetuses with left diaphragmatic hernia.
• Normal karyotype, no further severe anomalies on prenatal ultrasound study.
• Fetal liver herniation into the chest; gestational age-related lung volume between 20-25% of normal as determined by magnetic resonance imaging between 30+0 - 34+0 weeks+days of gestation.

Exclusion Criteria

• Any maternal disease or condition that would result in an increased risk to her health from the experimental procedure.
• Abnormal fetal karyotype, further severe fetal anomalies on prenatal ultrasound.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Fetoscopic tracheal balloon occlusion	-
B	Fetoscopic tracheal balloon occlusion	Fetoscopic tracheal occlusion

Primary Outcome Measures

Name	Time	Method
Need for postnatal ECMO therapy	First two days of life

Secondary Outcome Measures

Name	Time	Method
Survival to discharge from hospital	Days to discharge
Maternal morbidity	Until maternal discharge
Fetal / Neonatal morbidity	Overall & at discharge from hospital
Premature preterm rupture of membranes	Following the interventions over the remainder of gestation
Unintended preterm delivery	Following the interventions before scheduled elective delivery
Days in intensive care	Number of day until discharge from ICU
Days in hospital	Number of days until discharge from hospital
Oxygen dependency on discharge	Days until discharge

Trial Locations

Locations (1)

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