Actively Recruiting
Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-05-11
40
Participants Needed
1
Research Sites
526 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
CONDITIONS
Official Title
Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Isolated congenital diaphragmatic hernia (CDH) with liver up
- Severe pulmonary hypoplasia with ultrasound observed to expected lung-to-head ratio (O/E LHR) less than 25% at time of surgery
- Gestational age at FETO procedure between 27 weeks 0 days and 29 weeks 6 days for severe cases
- Moderate pulmonary hypoplasia with ultrasound O/E LHR less than 30% and liver-up at time of surgery
- Gestational age at FETO procedure between 30 weeks 0 days and 31 weeks 6 days for moderate cases
- Maternal age 18 years or older
- Gestational age at enrollment before 29 weeks 6 days, or before 31 weeks 6 days in moderate cases
- Normal karyotype or fluorescence in situ hybridization (FISH)
- Normal fetal echocardiogram
- Singleton pregnancy
- Willingness to remain in the greater Cincinnati area for the remainder of the pregnancy
- Family has considered and declined termination of pregnancy before 24 weeks 0 days
- Family meets psychosocial criteria
You will not qualify if you...
- Patient younger than 18 years old
- Multiple pregnancy (twins or more)
- Allergy to rubber latex
- Preterm labor, shortened cervix less than 15 mm, uterine anomaly strongly predisposing to preterm labor, or placenta previa
- Bilateral CDH or isolated left-sided CDH with O/E LHR greater than 30%
- Additional fetal anomalies detected by ultrasound, MRI, or echocardiogram
- Chromosomal abnormalities
- Maternal contraindications to fetoscopic surgery or severe maternal condition during pregnancy
- Incompetent cervix with or without cerclage
- Known placental abnormalities at enrollment
- Maternal HIV, Hepatitis B, or Hepatitis C infection
- Maternal uterine anomalies
- No safe or technically feasible fetoscopic approach to balloon placement
- Participation in another intervention study affecting maternal and fetal health or prior participation in this trial during a previous pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
F
Foong-Yen Lim, MD
CONTACT
J
Jose Peiro, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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