Actively Recruiting
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
Led by Hanmin Lee · Updated on 2026-01-28
10
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Despite advances in prenatal diagnosis and postnatal therapies, including ECMO (Extracorporeal Membrane Oxygenation), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. The rationale for fetal therapy in severe CDH is to promote adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. The investigator's goal with this pilot study is to study the feasibility of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with left CDH (LHR O/E \< 25%).
CONDITIONS
Official Title
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
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 or FISH if over 26 weeks
- Isolated left CDH with liver up
- Gestational age at enrollment prior to 29 weeks plus 6 days
- Severe pulmonary hypoplasia with ultrasound LHR O/E less than 25% measured between 18 and 29.5 weeks
- Gestational age at FETO procedure between 27 weeks 0 days and 29 weeks 6 days
- Family meets psychosocial criteria
- Pre-authorization from third-party payor for fetal intervention or ability to self-pay
- Informed consent
You will not qualify if you...
- Failure to meet all inclusion criteria
- Patient younger than 18 years
- Multi-fetal pregnancy
- Rubber latex allergy
- Preterm labor, cervix shortened less than 15 mm at enrollment or within 24 hours of FETO balloon insertion, or uterine anomaly strongly predisposing to preterm labor
- Placenta previa
- Family does not meet psychosocial criteria including insufficient social support or inability to understand study requirements or reside near San Francisco
- Right sided or bilateral CDH, isolated left sided with LHR O/E less than 25% as determined by ultrasound
- Additional fetal anomaly detected by ultrasound, MRI, or echocardiogram including chromosomal abnormalities, congenital heart disease, or genetic syndromes
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Known placental abnormalities such as previa, abruption, or accreta at enrollment
- Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting current pregnancy
- Maternal HIV, Hepatitis-B, or Hepatitis-C positive status without negative testing prior to enrollment
- Uterine anomaly such as large or multiple fibroids or Mullerian duct abnormality
- No safe or feasible fetoscopic approach to balloon placement
- Participation in another intervention study influencing maternal or fetal morbidity or mortality or prior participation in this trial in a previous pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California San Francisco Fetal Treatment Center
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
K
Katie Archbold, BA
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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