Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I

University Hospital, Bonn98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diaphragmatic Hernia

Interventions

Fetoscopic tracheal balloon occlusionPROCEDURE

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women from European countries carrying fetuses with congenital right or left diaphragmatic hernias * Normal karyotype, no further severe anomalies on prenatal ultrasound study * Fetal liver herniation into the chest, Lung-to-head ratio of ≥0,40 ≤0,84 between 30+0 - 33+5 weeks+days of gestation Exclusion Criteria: * Any maternal disease or condition that would result in an increased risk to her personal health from the experimental procedure * Abnormal fetal karyotype * Further severe fetal anomalies on prenatal ultrasound

Locations (2)

German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn

Bonn, Germany

Neonatal Intensive Care Unit (ECMO center), University of Mannheim

Mannheim, Germany

Outcomes

Primary Outcomes

Survival to discharge from hospital

Secondary Outcomes

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

Data from ClinicalTrials.gov

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