Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

University Hospital Bonn (UKB)

Status and phase

Unknown

Phase 2

Conditions

Diaphragmatic Hernia

Treatments

Procedure: Fetoscopic tracheal balloon occlusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00373438

FDH-ECMO/BALLOON-TRIAL-135/06

135/06

Details and patient eligibility

About

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.

Enrollment

98 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.