Fetoscopic procedure to treat severe congenital diaphragmatic hernia in fetuses

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

This study is testing a new procedure that uses a balloon to help fetuses with a serious lung condition grow their lungs better before birth, aiming to improve their chances of survival after delivery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Children's Hospitals and Clinics of Minnesota (other)
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT05771688 on ClinicalTrials.gov

What this trial studies

This pilot trial evaluates the feasibility and safety of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy for fetuses diagnosed with severe left congenital diaphragmatic hernia (CDH). The procedure involves placing a balloon device to block the airway, promoting lung growth by allowing fluid to accumulate in the lungs before birth. The study will enroll 10 pregnant women and their fetuses, with procedures conducted at the Midwest Fetal Care Center. The aim is to improve neonatal survival rates by enhancing fetal lung development.

Who should consider this trial

Good fit: Ideal candidates include pregnant women with a singleton pregnancy carrying a fetus diagnosed with severe left-sided congenital diaphragmatic hernia.

Not a fit: Patients with right-sided congenital diaphragmatic hernia or those with associated lethal anomalies will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the survival and quality of life for infants born with severe congenital diaphragmatic hernia.

How similar studies have performed: While this approach is novel, similar fetal interventions have shown promise in improving outcomes for congenital conditions, suggesting potential for success.

Eligibility criteria

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

Where this trial is running

Minneapolis, Minnesota

• Midwest Fetal Care Center — Minneapolis, Minnesota, United States (RECRUITING)

Study contacts

• Study coordinator: James E Fisher, MD

Conditions: Hernia, DIaphragmatic, Congenital