Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial

Study Overview
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Brief Summary
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The neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is higher than 90% due to severe pulmonary hypoplasia. Many studies have suggested that fetal tracheal occlusion may increase lung volumes and therefore reducing the risk for severe pulmonary hypoplasia and by consequence the risk for neonatal death. The main objective of the present study is to evaluate if fetal tracheal occlusion improves survival rate in those cases that are followed in our hospital, by conducing a randomized trial.

Detailed Description
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Fetuses will be randomly allocated in two groups: 1. for fetal tracheal occlusion at 26-28 weeks (FETO group) or 2. Postnatal therapy only (Control) Main outcome: Survival rate in both groups Second outcomes: Postnatal diagnosis of severe pulmonary arterial hypertension, percentage of newborns in each group that will have clinical conditions for neonatal surgical repair of the diaphragmatic defect, fetal lung responses (increase of fetal lung size), maternal and obstetrical complications (prematurity, preterm rupture of the membranes, maternal hemorrhage and infection).

Official Title
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Tracheal Occlusion Guided by Percutaneous Fetoscopy in Fetuses With Severe Isolated Congenital Diaphragmatic Hernia

Conditions
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Congenital Diaphragmatic Hernia, Congenital Abnormality

Intervention / Treatment
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* Procedure: Fetal tracheal occlusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ultrasound diagnosis of congenital diaphragmatic hernia fetuses at gestational age between 24 and 28 weeks absence of chromosomal and/or other structural anomalies (isolated congenital diaphragmatic hernia) severe congenital diaphragmatic hernia defined by lung-head ratio < 1.0 and more than 1/3 of liver herniated into fetal thorax and observed/expected fetal total lung volume < 0.35 patient's consent to participate in the present study Exclusion Criteria: Patient's refusal to participate in the study after allocation Preterm labor diagnosed before the procedure Preterm rupture of membranes before fetal intervention
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fetal intervention<br>Composed of fetuses that undergo to fetal tracheal occlusion at 26-28 weeks. | Procedure: Fetal tracheal occlusion<br>* Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy<br>* Other names: FETO, TO;|
| No Intervention: Control<br>Composed of fetuses that do not undergo fetal intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Noenatal survival rate which includes percentage of newborns that survive up to 30 days of life. Infant survival rate which includes percentage of newborns that survive up to one year of life. Outcome measurement will be assessed up to one year after birth. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postnatal pulmonary arterial hypertension | Postnatal pulmonary arterial hypertension will be assessed up to 30 days of life according to the echocardiographic findings. | 30 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital diaphragmatic hernia, Fetal anomalies