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Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
Recruiting
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
Who can join
Ages 18 and older · Women
Full eligibility criteria
Inclusion Criteria: * Pregnant women age 18 years and older, who are able to consent * Singleton pregnancy Fetal * Normal Karyotype * Fetal Diagnosis of Isolated Left CDH with liver up * Gestation at enrollment prior to 29 wks plus 6 days * SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR \< 25% Exclusion Criteria: * Pregnant women \<18 years of age. * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy * Technical limitations precluding fetoscopic surgery * Rubber latex allergy * Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa * Psychosocial ineligibility, precluding consent * Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25% * Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care
About the study
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
What is being tested
- Fetoscopic Endoluminal Tracheal Occlusion (FETO) (device)
Sponsor: Connecticut Children's Medical Center · Participants: 15 · Started: 2015-09
Contact the study team
- Katie E Boyle, MPH · Phone: 860-837-6547
Official record on ClinicalTrials.gov — NCT02530073
Locations in the U.S.
| Connecticut | Connecticut Children's Medical Center, Hartford |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.