Actively Recruiting
Safety and Efficacy of FETO in CDH: A Phase III Trial
Led by Holly L Hedrick, MD · Updated on 2025-07-25
80
Participants Needed
2
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.
CONDITIONS
Official Title
Safety and Efficacy of FETO in CDH: A Phase III Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women age 18 years and older
- Singleton pregnancy
- Normal fetal karyotype confirmed by culture, whole exome sequencing, whole genome sequencing, or chromosomal microarray with non-pathologic variants; FISH results acceptable if over 26 weeks
- Gestational age before 29 weeks 6 days at enrollment
- Liver is inside the chest (intrathoracic)
- Isolated left-sided congenital diaphragmatic hernia (CDH) with observed/expected lung to head ratio (O/E LHR) less than 30% at enrollment (18 to 29+5 weeks)
- Or isolated right-sided CDH with O/E LHR 45% or less at enrollment (18 to 29+5 weeks)
- Cervical length of 20 mm or more by transvaginal ultrasound within 24 hours before FETO procedure
- Meets psychosocial criteria
- Provided informed consent
You will not qualify if you...
- Patient younger than 18 years
- Multifetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shorter than 20 mm at enrollment or within 24 hours of FETO balloon insertion, uterine anomaly strongly predisposing to preterm labor, or placenta previa
- Psychosocial ineligibility preventing consent, including inability to stay within 30 minutes of CHOP or lack of support person during pregnancy
- Bilateral CDH; isolated left CDH with O/E LHR 30% or more; isolated right CDH with O/E LHR greater than 45%
- No liver herniation into the chest
- Additional fetal anomalies affecting survival prognosis or genetic syndromes
- Maternal medical conditions contraindicating fetoscopic surgery
- History of incompetent cervix with or without cerclage
- Known placental abnormalities at enrollment
- Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia
- Positive maternal HIV, Hepatitis B, or Hepatitis C status
- Uterine anomalies such as large or multiple fibroids or mullerian duct abnormalities
- No safe or feasible fetoscopic approach to balloon placement
- Participation in another intervention study affecting maternal or fetal outcomes or previous participation in this trial during another pregnancy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
H
Holly L Hedrick, MD, FACS
CONTACT
A
Annaliese Aarthun
CONTACT
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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