Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Study Overview
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Brief Summary
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The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Detailed Description
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Prenatal tracheal occlusion (TO) obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%. The goal of this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH Observed/expected lung-to-head ratio < 25%(O/E LHR < 25%).

Official Title
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Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

Conditions
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Congenital Diaphragmatic Hernias

Intervention / Treatment
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* Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women age 18 years and older, who are able to consent Singleton pregnancy Fetal Normal Karyotype Fetal Diagnosis of Isolated Left CDH with liver up Gestation at enrollment prior to 29 wks plus 6 days SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR < 25% Exclusion Criteria: Pregnant women <18 years of age. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy Technical limitations precluding fetoscopic surgery Rubber latex allergy Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa Psychosocial ineligibility, precluding consent Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25% Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fetoscopic Endoluminal Tracheal Occlusion (FETO)<br>An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH) | Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)<br>* This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed/expected length head ratio <25% (O/E LHR).<br>* Other names: BALT GOLDBAL2 Tracheal Balloon Catheter system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of neonatal survivors at time of discharge |  | Discharge from the hospital, an expected average of 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prenatal increase in lung volume | Lung volume after FETO procedure | 2 weeks (prenatally) | 
| Number of days of Postnatal mechanical ventilator support | mechanical ventilator support will be monitored and recorded in days of use | First 28 days of postnatal life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital diaphragmatic hernia, FETO, tracheal occlusion