Fetoscopic Endoluminal Tracheal Occlusion (FETO)

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

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 Minnesota. 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.

Study Overview

• Status: Recruiting
• Conditions: Hernia, DIaphragmatic, Congenital
• Intervention / Treatment: Device: FETO therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James E Fisher, MD; Phone Number: 612.863.9924; Email: jfisher@pediatricsurgical.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Recruiting
      • Midwest Fetal Care Center
      • Contact: James E Fisher, MD; Phone Number: 612-863-9924; Email: jfisher@pediatricsurgical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. A subject is defined as a female (18 years or older) who is pregnant.
2. The pregnancy must be a singleton pregnancy.
3. The CDH must be left-sided.
4. The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - < 25% from U/S measurements).
5. No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype.
6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects.
7. Gestational age at time of balloon placement between and including 27 weeks 0 days and 29 weeks 6 days.
8. Cervix length longer than 20 mm at pre-balloon placement evaluation.
9. Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis.
10. Written consent must be obtained.
11. 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:

1. Twin or higher order gestation
2. Not able to consent
3. Right-sided or bilateral CDH
4. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
5. Maternal isoimmunization or neonatal alloimmune thrombocytopenia
6. Balloon not able to be placed prior to 30 weeks gestation
7. CDH O/E LHR 25% or greater
8. 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)
9. 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
10. Short cervix (20 mm or less)
11. History of incompetent cervix or uterine anomaly predisposing to preterm labor
12. Significant placental abnormalities (abruption, chorioangioma, accrete) known at the time of enrollment and/or surgery
13. History of natural rubber latex allergy
14. No safe or feasible fetoscopic approach to balloon placement
15. Inability to relocate to within 15 minutes of MWFCC/Children's Minnesota

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FETO therapy	Device: FETO therapy; placement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days; Other Names: Fetoscopic Endoluminal Tracheal Occlusion; GOLDBALLOON; BALTACCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful removal of Balt Goldbal2 balloon	Removal of the balloon	Prior to 35 weeks 6 days GA
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 weeks 6 days Gestational Age (GA)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infants requiring extra corporeal membrane oxygenation (ECMO) support	Use of ECMO will be collected from medical chart review.	Birth to 6 months
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 tracheostomy while in the NICU	Tracheostomy information 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
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.	Immediately after intervention (device removal)
Number of infants requiring home oxygen support upon discharge from the NICU	Oxygen support will be collected from medical chart review.	up to 2 years of age

Collaborators and Investigators

• Sponsor: Children's Hospitals and Clinics of Minnesota
• Collaborators: Allina Health System

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Hernia; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: 1397678; 2021-055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes