Fetoscopic Endoluminal Tracheal Occlusion

Hernia, DIaphragmatic, Congenital Clinical Trial

— FETO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771688
• Other study ID #: 1397678; 2021-055
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: September 2028

Study information

• Verified date: February 2024
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: James E Fisher, MD
• Phone: 612.863.9924
• Email: jfisher[@]pediatricsurgical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Diaphragmatic
• Hernia, DIaphragmatic, Congenital
• Hernias, Diaphragmatic, Congenital

Intervention

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

Locations

Country	Name	City	State
United States	Midwest Fetal Care Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota	Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Successful removal of Balt Goldbal2 balloon	Removal of the balloon	Prior to 35 weeks 6 days GA
Secondary	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)
Secondary	Gestational age at delivery	Gestational age at delivery will be recorded.	Measured at time of delivery
Secondary	Infant survival	Infant survival will be recorded from delivery to NICU discharge, and at 6, 12, and 24 months of age	Birth - 24 months
Secondary	Number of infants requiring extra corporeal membrane oxygenation (ECMO) support	Use of ECMO will be collected from medical chart review.	Birth to 6 months
Secondary	Number of infants requiring tracheostomy while in the NICU	Tracheostomy information will be collected from medical chart review.	up to 2 years of age
Secondary	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
Secondary	Time to pulmonary hypertension resolution	pulmonary hypertension will be collected from medical chart review.	up to 2 years of age