Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia

Study Overview
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Brief Summary
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Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Detailed Description
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Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected lung-to-head ratio of <25%, LHR <1, or a moderate category with o/e LHR <30%, singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days (severe), gestational age < 31 weeks 6 days (moderate), no maternal disease, maternal age > 18 years old…. meet criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in our center.

Official Title
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Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia

Conditions
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Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary; Hypertension

Intervention / Treatment
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* Device: Fetal Tracheal Occlusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated CDH with liver up Severe pulmonary hypoplasia with ultrasound O/E LHR <25% at the time of surgery Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days Moderate pulmonary hypoplasia with ultrasound O/E LHR <30% and liver-up at the time of surgery Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category Maternal age greater than or equal to 18 years Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category Normal karyotype or FISH Normal fetal echocardiogram Singleton pregnancy Willing to remain in the greater Cincinnati area for remainder of pregnancy Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days Family meets psychosocial criteria Exclusion Criteria: Patient < 18 years old Multi-fetal pregnancy Rubber latex allergy Preterm labor, cervix shortened (<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa Bilateral CDH, isolated left sided CDH with an O/E > 30% Additional fetal anomaly by ultrasound, MRI, or echocardiogram Chromosomal abnormalities Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy Incompetent cervix with or without a cerclage Placental abnormalities known at time of enrollment Maternal HIV, Hepatits B, Hepatitis C Maternal uterine anomaly No safe or technically feasible fetoscopic approach to balloon placement Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fetal Tracheal Occlusion<br>Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth. | Device: Fetal Tracheal Occlusion<br>* Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of <25%, LHR <1, o/e LHR<30% (moderate), singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days, no maternal disease, maternal age > 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center as a requirement to enter the TOTAL trial.<br>* Other names: Fetal Endoluminal Tracheal Occlusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change lung growth on prenatal imaging | Change in o/eLHR and other prenatal imaging tests | prenatal period up to 40 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change survival in the severe congenital diaphragmatic hernia subgroup | Change rate of survival | 6 months | 
| Change need for ECMO therapy | Change need for ECMO therapy | 6 months | 
| Change pulmonary hypertension | Change pulmonary hypertension | 6 months | 
| Change neonatal morbidity | Change neonatal morbidity | 1 year |