Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

University Hospital, Bonn98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diaphragmatic Hernia

Interventions

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Need for postnatal ECMO therapy

Time frame: First two days of life

Secondary Outcomes

Survival to discharge from hospital

Time frame: Days to discharge

Maternal morbidity

Time frame: Until maternal discharge

Fetal / Neonatal morbidity

Time frame: Overall & at discharge from hospital

Premature preterm rupture of membranes

Time frame: Following the interventions over the remainder of gestation

Unintended preterm delivery

Time frame: Following the interventions before scheduled elective delivery

Days in intensive care

Time frame: Number of day until discharge from ICU

Days in hospital

Time frame: Number of days until discharge from hospital

Oxygen dependency on discharge

Time frame: Days until discharge