Fetoscopic Endoluminal Tracheal Occlusion

Recruiting now · Not applicable

Conditions studied: Hernia, DIaphragmatic, Congenital

In brief

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.

Key facts

Study ID

NCT05771688

Run by

Children's Hospitals and Clinics of Minnesota

People needed

10

Starts

2024-02-22

Expected to finish

2028-09-01

Last updated by the study team

2024-02-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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