Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

Study Overview
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Brief Summary
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The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).

Official Title
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Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863

Conditions
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Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary Artery Hypertension

Intervention / Treatment
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* Device: BALT GoldbBAL2 Detachable Balloon
* Device: Catheter System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks. Isolated Left CDH with liver up Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) < 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to <30% (measured at 300 to 316 weeks) at time of surgery. Gestational age at FETO procedure with O/E LHR <25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to <30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound Patient meets psychosocial criteria Exclusion Criteria: Multi-fetal pregnancy History of natural 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: Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution. Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy History of incompetent cervix with or without cerclage Placental abnormalities (previa, abruption, accrete) known at time of enrollment Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality 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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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: FETO Group<br>Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system. | Device: BALT GoldbBAL2 Detachable Balloon<br>* Latex balloon, with radio-opaque inclusion<br>Device: Catheter System<br>* 100 cm tapered micro-catheter<br>* Other names: BALTACCIBDPE100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successfully completed FETO procedures | The number of successful placement and removal of balloon during FETO procedure | Up to 34 weeks gestation | 
| Operative time | FETO placement and release operative times reported in minutes | Up to 34 weeks gestation | 
| Frequency of unplanned balloon removal | The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal) | Up to 34 weeks gestation | 
| Number of incidences of maternal complications | Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis | Up to 41 weeks gestation | 
| Number of participants with maternal complications | Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis | Up to 41 weeks gestation | 
| Gestational Age at Delivery | Gestation Age reported at time of delivery | Up to 41 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Lung Growth as measured via Fetal Lung Volume | Fetal Lung Volume as measured via ultrasound | Up to 41 weeks gestation | 
| Fetal Lung Growth as measured via LHR | Lung area to head circumference Ratio (LHR) as measured via ultrasound | Up to 41 weeks gestation | 
| Fetal survival | Fetal survival reported in days | Up to 24 months post partum | 
| Number of newborns reported at each oxygen dependency grading | Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician | Up to 24 months post partum | 
| Number of occurrence of severe pulmonary hypertension | Number of occurrence of severe pulmonary hypertension in infants as measured via echocardiogram | Up to 24 months post partum | 
| Number of infants requiring ECMO Support | Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support | Up to 24 months post partum | 
| Number of days in neonatal intensive care unit | Number of days infant was in the neonatal intensive care unit | Up to 24 months post partum | 
| Number of days of ventilator support | Number of reported days infants required ventilator support | Up to 24 months post partum | 
| Number of days of maternal hospitalization | Number of reported days of maternal hospitalization | Up to 24 months post partum | 
| Number of infants reporting presence of complications | Number of infants reporting the presence of: periventricular leucomalacia at < 2 months postnatally, neonatal sepsis, intraventricular hemorrhage (grade 0-III), retinopathy of prematurity (grade III or higher), gastro-esophageal reflux, tracheomegaly and tracheomalacia | Up to 24 months post partum | 
| Number of infants requiring the use of patch or muscle flap | Number of infants reported to require the use of patch or muscle flap | Up to 24 months post partum | 
| Number of participants at each route of delivery | Number of participants that delivered vaginally and via caesarean section | Day 1 (post partum) | 
| Number of days of Diaphragmatic Repair | Number of days of infant Diaphragmatic Repair | Up to 24 months post partum | 

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