Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diaphragmatic Hernia

Intervention / Treatment
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* Procedure: Fetoscopic tracheal balloon occlusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br> | Procedure: Fetoscopic tracheal balloon occlusion<br>* 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<br>|
| Experimental: B<br>Fetoscopic tracheal occlusion | Procedure: Fetoscopic tracheal balloon occlusion<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for postnatal ECMO therapy |  | First two days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy, ECMO