Fetal endoscopic tracheal occlusion for severe congenital diaphragmatic hernia
A Study of the Effectiveness of Fetal Endoscopic Tracheal Occlusion (FETO) in the Management of Severe Prenatally Diagnosed Congenital Diaphragmatic Hernia (CDH)
This study is testing if placing a balloon in the trachea of fetuses with severe congenital diaphragmatic hernia can help their lungs develop better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05461222 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of fetal endoscopic tracheal occlusion (FETO) in treating severe congenital diaphragmatic hernia (CDH). It involves the insertion of a balloon into the fetal trachea to improve lung development and function. The study will collect data on the safety and effectiveness of the off-label use of the FETO Goldballoon, manufactured by Balt medical, in a specialized medical center with advanced maternal-fetal medicine and neonatal services. The goal is to assess the risks and benefits of this intervention for affected fetuses.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18-50 with a singleton gestation and severe CDH as defined by specific criteria.
Not a fit: Patients with associated fetal structural cardiac anomalies or other significant structural anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve outcomes for fetuses diagnosed with severe congenital diaphragmatic hernia.
How similar studies have performed: Other studies have shown promise with similar interventions, but this specific approach is still being evaluated for its efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Maternal Age: 18-50 * Singleton gestation * Gestational age before 29 weeks 6 days * Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms. For severe right sided CDH o/e LHR less than 30 % between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms. * Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS) * Absence of associated fetal structural cardiac anomalies by a dedicated fetal echocardiogram * Absence of other structural anomalies by ultrasound or MRI * Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT). * Must be willing to remain near LPCH Stanford (within 30 minutes from the hospital) for the duration of the balloon placement. * No maternal and/or fetal contra-indications to fetal surgery such as a bleeding disorder, poorly controlled diabetes or hypertension, short cervix (measuring \< 20mm), risk for preterm birth etc. * Planned pregnancy surveillance at LPCH Stanford * Planned delivery at LPCH Stanford * Able to provide written consent * Willingness to comply with all study procedures and availability (meets psychosocial criteria) for the duration of the study including having a support person Exclusion Criteria: * Contraindications to fetal surgery including poorly controlled hypertension, diabetes or other maternal medical condition including hematological disorder * High risk for preterm labor and/or delivery based on either significant history of preterm birth, short cervix (measuring \< 20mm), significant uterine anomaly or other risk factor, incompetent cervix (requiring cerclage) * Non-isolated CDH - CDH with additional structural anomalies * Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI is a calculation which includes a person's height and weight * History of natural rubber latex allergy * Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality * Participation in another intervention study that influences maternal and fetal morbidity and mortality. * Bilateral CDH, left-sided CDH with O/E LHR \>25%, or left-sided CDH with O/E LHR \<25% but liver completely down in abdomen * Right-sided CDH O/E LHR \>30% or right-sided CDH with O/E LHR \<30% with liver completely down in abdomen * Significant placental abnormalities (abruption, chorioangioma, accreta) known at the time of enrollment and/or surgery * Maternal-fetal Rhesus isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia, affecting the current pregnancy. * Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure * No safe or feasible fetoscopic approach to balloon placement.
Where this trial is running
Stanford, California
- Lucile Packard Children's Hospital — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Yair Blumenfeld, MD — Stanford University
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.