Fetoscopic procedure to treat severe congenital diaphragmatic hernia in fetuses
Official title: Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
Run by Connecticut Children's Medical Center · NCT02530073 · Data updated 2026-11-12
This study is testing a new prenatal procedure to help fetuses with severe congenital diaphragmatic hernia grow their lungs better by temporarily blocking their trachea.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 15 (estimated) |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Status | Recruiting |
| Started | September 2015 |
| Main results expected | August 2028 |
| Study ends | August 2030 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT02530073 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women over 18 years old with a singleton pregnancy and a fetus diagnosed with isolated left CDH and severe pulmonary hypoplasia.
✕Probably not a fit
Patients with right-sided or bilateral diaphragmatic hernias, or those with major associated anomalies, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of Fetoscopic Endoluminal Tracheal Occlusion (FETO) as a prenatal therapy for fetuses diagnosed with severe congenital diaphragmatic hernia (CDH). The approach involves obstructing the normal flow of lung fluid to promote lung growth, which is critical for neonatal survival. The study aims to assess the feasibility of this technique in fetuses with a severely low lung-to-head ratio, building on previous findings that showed improved survival rates in similar cases. Participants will undergo fetoscopic surgery to place and later remove a tracheal balloon in utero.
Why it matters
Potential benefit: If successful, this procedure could significantly improve survival rates for newborns with severe congenital diaphragmatic hernia.
How similar studies have gone: Previous studies have shown improved survival rates with similar fetoscopic techniques, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Connecticut Children's Medical Center
Hartford, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Timothy Crombleholme, MD — Connecticut Children's Medical Center
- Study coordinator: Katie E Boyle, MPH
- Email: Kboyle01@connecticutchildrens.org
- Phone: 860-837-6547
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.