Actively Recruiting
Effectiveness of Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Prenatal Congenital Diaphragmatic Hernia Management
Led by Yair Blumenfeld · Updated on 2026-01-29
15
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of fetal endoscopic tracheal occlusion (FETO) for treating severe congenital diaphragmatic hernia (CDH) diagnosed before birth. The study also collects safety and effectiveness data for the off-label use of the FETO Goldballoon device, which is inserted into the fetal windpipe to support lung development. The trial is conducted at an advanced medical center with specialized maternal-fetal medicine, neonatal care, and pediatric surgery services. The treatment involves placing a balloon inside the fetus's trachea using a fetoscope, a small camera inserted into the amniotic cavity. This balloon is removed before delivery. After birth, children will have follow-up visits until they reach 2 years of age. The study focuses on cases of severe left or right-sided CDH and involves close multidisciplinary counseling and planning for delivery at the study hospital. Participants will be monitored through their pregnancy and after birth with assessments including survival rates at various milestones up to 2 years of age and the need for extracorporeal membrane oxygenation (ECMO). The primary outcome is the number of newborns who survive until initial hospital discharge, typically about 6 months. The study requires participants to remain near the hospital during balloon placement and includes thorough genetic and ultrasound screenings to confirm eligibility.
CONDITIONS
Brief Title
Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age between 18 and 50 years
- Singleton pregnancy
- Gestational age before 29 weeks and 6 days
- Severe left or right-sided congenital diaphragmatic hernia (CDH) based on specific lung size and liver position criteria
- Normal genetic test results by amniocentesis or chorionic villus sampling
- No fetal heart or other major structural anomalies confirmed by ultrasound or MRI
- Multidisciplinary counseling completed with specialists
- Willingness to stay within 30 minutes of the study hospital during balloon placement
- No maternal or fetal contraindications to fetal surgery such as bleeding disorders, uncontrolled diabetes, hypertension, or short cervix
- Planned pregnancy care and delivery at the study hospital
- Ability to provide written consent
- Willingness to comply with study procedures and have support available during the study period
You will not qualify if you...
- Maternal medical conditions that contraindicate fetal surgery, including poorly controlled hypertension or diabetes and blood disorders
- High risk for preterm labor or delivery due to medical history, short cervix, uterine anomalies, or incompetent cervix
- CDH with additional structural anomalies (non-isolated CDH)
- Significant maternal obesity (BMI greater than 40)
- History of natural rubber latex allergy
- Uterine abnormalities such as large or multiple fibroids or mullerian duct abnormalities
- Participation in another intervention study affecting maternal or fetal health
- Bilateral CDH or less severe CDH cases not meeting severity criteria
- Significant placental abnormalities known at enrollment
- Maternal-fetal blood incompatibilities or infections that risk fetal transmission
- No safe or feasible approach for fetoscopic balloon placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From placement until balloon removal before delivery
Participants undergo fetal endoscopic tracheal occlusion (FETO), where a balloon is placed in the fetus's windpipe using a fetoscope to aid lung development. The balloon is removed prior to delivery.
1 procedure visit (in-utero) and balloon removal visit (prior to delivery)
Duration - Up to 2 years after birth
Children have follow-up visits to monitor health and development until the age of 2 years.
Regular follow-up visits until 2 years of age
Trial Site Locations
Total: 1 location
1
Lucile Packard Children's Hospital
Stanford, California, United States, 94305-6070
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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