Actively Recruiting
North American Fetal Therapy Network Prospective Registry for Long-term Outcomes Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Led by Johns Hopkins University · Updated on 2026-04-23
80
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
K
KARL STORZ Endoscopy-America, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying Fetoscopic Endoluminal Tracheal Occlusion (FETO) to improve survival and reduce long-term health problems in fetuses with severe isolated congenital diaphragmatic hernia (CDH). This study focuses on fetuses with left CDH and very low lung size or right CDH with moderate lung size, all with liver herniation into the chest. They plan to enroll 80 pregnant women and follow their children for up to 24 months to compare outcomes between those receiving FETO and those receiving standard care. Participants in the FETO group will undergo a two-step procedure between 27 and 30 weeks of pregnancy: first, a balloon is inserted into the fetal windpipe, then removed around 34 weeks. The planned delivery happens after 37 weeks. The control group will receive standard care without the FETO procedure. After birth, children will be monitored for two years to track survival, lung health, infections, growth, and neurological development. Throughout the study, participants will have regular ultrasounds and clinical visits to monitor pregnancy and fetal health. Researchers will collect data on procedure success, complications, survival rates at birth and over two years, and various health issues such as lung hypertension, infections, brain injuries, and growth. This comprehensive monitoring aims to understand the benefits and risks of FETO compared to standard care for severe CDH cases.
CONDITIONS
Brief Title
Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women age 18 years and older
- Singleton pregnancy
- Normal karyotype or acceptable genetic test results
- Gestational age before 29 weeks + 6 days at enrollment
- Isolated left CDH with o/e LHR less than 30% at enrollment
- Isolated right CDH with o/e LHR 45% or less at enrollment
- Cervical length 20 mm or more within 24 hours before FETO
- Meets psychosocial criteria
- Informed consent understood
You will not qualify if you...
- Patient under 18 years of age
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shorter than 20 mm at enrollment or before FETO
- Uterine anomalies predisposing to preterm labor or placenta previa
- Psychosocial ineligibility including no support person or residence too far from treatment center
- Bilateral CDH or left CDH with o/e LHR 30% or more
- Right CDH with o/e LHR over 45%
- No liver herniation into thoracic cavity
- Additional fetal anomalies or chromosomal abnormalities affecting prognosis
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition
- History of incompetent cervix
- Known placental abnormalities
- Maternal-fetal blood incompatibilities affecting pregnancy
- Maternal HIV, Hepatitis-B, or Hepatitis-C positive
- Uterine anomalies like large fibroids
- No safe or feasible fetoscopic approach to balloon placement
- Participation in another intervention study affecting maternal or fetal outcomes or prior participation during a previous pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 29 weeks + 6 days of gestation before enrollment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Approximately 1 visit for balloon insertion
Participants undergo the FETO procedure which involves inserting a balloon into the fetal trachea between 27 weeks + 0 days to 29 weeks + 6 days of gestation.
1 visit (in-person) for balloon insertion procedure
Duration - Weekly from balloon insertion until 34 weeks + 6 days of gestation
After the FETO procedure, participants are monitored weekly by ultrasound to assess fetal wellbeing and device status until balloon removal.
Weekly visits for ultrasound monitoring
Duration - Approximately 1 visit for balloon removal
The balloon is removed from the fetal trachea between 34 weeks + 0 days to 34 weeks + 6 days of gestation.
1 visit (in-person) for balloon removal procedure
Duration - From birth to 24 months after delivery
Participants are planned for delivery after 37 weeks of gestation and newborns are followed from birth to 24 months of age to evaluate long-term outcomes.
Multiple follow-up visits over 24 months for long-term monitoring
Trial Site Locations
Total: 1 location
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
A
Ahmet Baschat, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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