Fetal tracheal occlusion (FETO) for severe congenital diaphragmatic hernia
Safety and Efficacy of FETO in CDH Phase III
This trial will test whether fetal endoluminal tracheal occlusion (FETO) helps fetuses with severe congenital diaphragmatic hernia and intrathoracic liver herniation survive to hospital discharge.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT07187206 on ClinicalTrials.gov |
What this trial studies
Pregnant adults carrying a singleton fetus with intrathoracic liver herniation and severe lung hypoplasia (left CDH o/e LHR <30% or right CDH o/e LHR <45%) are enrolled at about 18 to 29 weeks' gestation. Enrolled participants receive either FETO using an FDA IDE–approved device or standard prenatal management matched for defect side and fetal lung volume estimates. The primary outcome is neonatal survival to hospital discharge, with secondary outcomes including long-term morbidity measures. Eligibility requires normal fetal karyotype, adequate cervical length, and meeting psychosocial and consent criteria, and procedures are performed at Cincinnati Children's Hospital Medical Center.
Who should consider this trial
Good fit: Ideal candidates are pregnant adults with a singleton fetus diagnosed with intrathoracic liver herniation and severe lung hypoplasia by o/e LHR (left <30% or right <45%) between about 18 and 29 weeks' gestation.
Not a fit: Patients without intrathoracic liver herniation, with milder o/e LHR values, multi-fetal pregnancies, or contraindications such as short cervix or latex allergy are unlikely to receive benefit from this procedure.
Why it matters
Potential benefit: If successful, FETO could increase survival to hospital discharge and reduce long-term respiratory and developmental complications for babies with very severe CDH.
How similar studies have performed: Previous single-center series and smaller trials of FETO have suggested improved survival in some severe CDH cohorts, but results have been mixed and large Phase III evidence has been limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women 18 years and older, who are able to consent * Singleton pregnancy * Gestational age at enrollment is prior to 296 weeks * Intrathoracic liver herniation * Isolated Left CDH with o/e LHR \< 30% at enrollment (180 to 295 weeks) or * Isolated Right CDH with o/e LHR \< 45% at enrollment (180 to 295 weeks) * Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks * Cervical length by transvaginal ultrasound \> 20 mm within 24 hours prior to FETO procedure * Patient meets psychosocial criteria * Informed consent understood Exclusion Criteria * Patient \< 18 years of age * Multi-fetal pregnancy * History of natural rubber latex allergy * Preterm labor, cervix shortened (\< 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa. * Psychosocial ineligibility, precluding consent: * Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial. * The patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Cincinnati Children's Hospital Medical Center. * Bilateral CDH, isolated LCDH with o/e LHR ≥ 30%, isolated RCDH with o/e LHR \> 45%, as determined by ultrasound. * No liver herniation into thoracic cavity * Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center. * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy * History of incompetent cervix with or without cerclage * Placental abnormalities (previa, abruption, accreta) known at time of enrollment * Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy * Maternal HIV, Hepatitis-B, Hepatitis-C positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before enrollment. * Positive Hepatitis B surface antigen or presence of Hepatitis C in maternal blood uterine anomaly such as Mullerian duct abnormality, large or multiple fibroids that prohibit safe fetoscopic procedure * There is no safe or technically feasible fetoscopic approach to balloon placement * Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center (CCHMC) — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Foong-Yen Lim, MD
- Email: Foong-Yen.Lim@cchmc.org
- Phone: (513) 636-6259
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.