Fetoscopic Endoluminal Tracheal Occlusion

Study Overview
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Brief Summary
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This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's MN. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.

Detailed Description
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This is a single site pilot trial to assess the feasibility and safety of treating the most severe group of fetuses with left CDH with Fetal Endoluminal Tracheal Occlusion (FETO) using the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Midwest Fetal Care Center (MWFCC), a collaboration between Allina Health and Children's MN. Congenital Diaphragmatic Hernia (CDH) is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up in the lungs and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life. The rationale for fetal therapy in severe CDH is to improve fetal lung growth and therefore neonatal survival. The study will enroll pregnant women that meet study criteria, and their baby. The mother-fetus participant will undergo one procedure for placement of FETO before gestational age 29 weeks 6 days; and a second procedure for removal of the FETO device. The timing for removal of FETO is no later than 35 weeks and 6 days. After delivery, routine care of the baby with CDH will occur within the Children's MN NICU.

Official Title
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Fetoscopic Endoluminal Tracheal Occlusion for Severe Left-sided Congenital Diaphragmatic Hernia

Conditions
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Hernia, DIaphragmatic, Congenital

Intervention / Treatment
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* Device: FETO therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject is defined as a female (18 years or older) who is pregnant. The pregnancy must be a singleton pregnancy. The CDH must be left-sided. The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - < 25% from U/S measurements). No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects. Gestational age at time of balloon placement between and including 27 weeks 0 days and 29 weeks 6 days. Cervix length longer than 20 mm at pre-balloon placement evaluation. Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis. Written consent must be obtained. Must meet psychosocial criteria including appropriate family/friend support during stay with balloon in place (cannot stay without additional helper), no current illicit drug use, no over-the-counter drug abuse, and no ineffectively treated DSM-IV diagnoses. Exclusion Criteria: Twin or higher order gestation Not able to consent Right-sided or bilateral CDH Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome Maternal isoimmunization or neonatal alloimmune thrombocytopenia Balloon not able to be placed prior to 30 weeks gestation CDH O/E LHR 25% or greater Maternal factors precluding safe fetal surgery (maternal cardiac findings not safe for anesthesia, maternal morbid obesity precluding safe usage of the equipment required for entry into the uterus, spontaneous preterm delivery prior to 36 weeks) Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risks of fetal transmission during procedures Short cervix (20 mm or less) History of incompetent cervix or uterine anomaly predisposing to preterm labor Significant placental abnormalities (abruption, chorioangioma, accrete) known at the time of enrollment and/or surgery History of natural rubber latex allergy No safe or feasible fetoscopic approach to balloon placement Inability to relocate to within 15 minutes of MWFCC/Children's Minnesota

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FETO therapy<br>FETO therapy | Device: FETO therapy<br>* placement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days<br>* Other names: BALTACCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful placement of Balt Goldbal2 balloon | Successful completion of balloon insertion in fetuses with severe CDH defined as direct visualization of balloon above the carina at the time of FETO procedure. | Prior to 29 weelks 6 days GA | 
| Successful removal of Balt Goldbal2 balloon | Removal of the balloon | Prior to 35 weeks 6 days GA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fetal lung growth | Prenatal ultrasound will measure the observed-to-expected lung to head ratio (o/e LHR) at weekly visits while the balloon is in place and after balloon removal. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR after balloon removal. | Immediatly after intervention (device removal) | 
| Gestational age at delivery | Gestational age at delivery will be recorded. | Measured at time of delivery | 
| Infant survival | Infant survival will be recorded from delivery to NICU discharge, and at 6, 12, and 24 months of age | Birth - 24 months | 
| Number of infants requiring extra corporeal membrane oxygenation (ECMO) support | Use of ECMO will be collected from medical chart review. | Birth to 6 months | 
| Number of infants requiring tracheostomy while in the NICU | Tracheostomy information will be collected from medical chart review. | up to 2 years of age | 
| Number of infants requiring home oxegen support upon discharge from the NICU | Oxegen support will be collected from medical chart review. | up to 2 years of age | 
| Time to pulmonary hypertension resolution | pulmonary hypertension will be collected from medical chart review. | up to 2 years of age |