Fetoscopic procedure to treat severe congenital diaphragmatic hernia in fetuses
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT02530073 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with right-sided or bilateral diaphragmatic hernias, or those with major associated anomalies, will not benefit from this study.
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 performed: Previous studies have shown improved survival rates with similar fetoscopic techniques, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Hartford, Connecticut
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.