Early FETO for Severe Congenital Diaphragmatic Hernia

Study Overview
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Brief Summary
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Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in those cases with severe forms where there are extremely reduced lung volumes, liver herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal pulmonary response followed FETO can be used to predict outcome and is dependent on the size of the fetal lung prior to the procedure. We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form of CDH will have a better fetal pulmonary response and higher chance of surviving.

Detailed Description
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We pretend to investigate if early FETO will improve the survival rate and the fetal pulmonary response, by conducting a randomized controlled trial comparing the results with those fetuses that undergo to standard FETO (between 26-28 weeks).

Official Title
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Early Versus Standard Fetal Endoscopic Tracheal Occlusion for Severe Congenital Diaphragmatic Hernia - a Randomized Controlled Trial

Conditions
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Congenital Diaphragmatic Hernia

Intervention / Treatment
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* Other: Fetal endoscopic tracheal occlusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fetuses with isolated congenital diaphragmatic hernia (normal fetal karyotype and absence of any associated structural anomaly); Gestational age established by last menstruation and/or first trimester ultrasonography; Prenatal diagnosis of congenital diaphragmatic hernia before 24 weeks of gestation Severe congenital diaphragmatic hernia (at 24 weeks, lung-to-head ratio <1.0 and at least 1/3 of the liver herniated into the fetal thorax) written informed consent (by the patient) Exclusion Criteria: Preterm premature rupture of the membranes before randomization Preterm labor before randomization

Ages Eligible for Study
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Minimum Age: 22 Weeks
Maximum Age: 28 Weeks

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard FETO<br>Group of fetus that undergo fetal endoscopic tracheal occlusion between 26 0/7 weeks and 28 6/7 weeks. | Other: Fetal endoscopic tracheal occlusion<br>* FETO will be performed by placing a detachable balloon inside fetal trachea<br>* Other names: FETO or fetal endoscopic traqueal occlusion;|
| Experimental: Early FETO<br>Group of fetus that undergo fetal endoscopic tracheal occlusion between 22 0/7 weeks and 24 6/7 weeks. | Other: Fetal endoscopic tracheal occlusion<br>* FETO will be performed by placing a detachable balloon inside fetal trachea<br>* Other names: FETO or fetal endoscopic traqueal occlusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant survival rate | Percentage of survivors at 6 months of life | 6 months of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postnatal severe pulmonary arterial hypertension (PAH) | Severe PAH will be considered when the neonate presents with profound cyanosis associated with echocardiographic continuous right-to-left shunting through a persistent 'ductus arteriosus' and a persistent difference in pre- to postductal saturation gradient >20%, despite the use of intake Nitric Oxide (iNO). | 30 days of life | 
| Respiratory morbidity | Need for ventilatory support and/or oxygen dependency. | 6 months of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital diaphragmatic hernia, fetoscopy, fetal endoscopic tracheal occlusion, pulmonary hypoplasia, fetal surgery, fetal lung