Fetal treatment for severe congenital diaphragmatic hernia
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia
NA · University of California, Davis · NCT05421676
This study is testing a new procedure for pregnant women with severe congenital diaphragmatic hernia to see if it can help improve their baby's lung development before birth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, Davis (other) |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT05421676 on ClinicalTrials.gov |
What this trial studies
This pilot trial evaluates the feasibility and safety of Fetal Endoscopic Tracheal Occlusion (FETO) using the Goldballoon Detachable Balloon at UC Davis Medical Center. Pregnant women with severe congenital diaphragmatic hernia (CDH) will undergo the procedure between 27 and 29 weeks of gestation. The study aims to monitor the outcomes and safety of this intervention, requiring participants to attend weekly follow-up appointments until delivery. The trial focuses on a specific patient population with severe pulmonary hypoplasia associated with CDH.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older with singleton pregnancies diagnosed with severe CDH and willing to comply with study protocols.
Not a fit: Patients with major structural cardiac defects or those who do not meet the specific inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for fetuses diagnosed with severe congenital diaphragmatic hernia.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating congenital conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study 3. Pregnant women, age 18 years and older 4. Singleton pregnancy 5. No pathogenic variants on microarray or pathologic findings on karyotype 6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects 7. Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR \<25% with liver up 8. Gestational age at FETO procedure: if o/e LHR \<25% will be done at 27 weeks plus 0 days to 29 weeks plus 6 days 9. Meets psychosocial criteria * Willing to reside within 30 minutes of UC Davis Medical Center and ability to maintain follow up appointments * Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near the UC Davis Medical Center. * Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work Exclusion Criteria: 1. Adults unable to consent 2. Prisoners 3. Multi-fetal pregnancy 4. History of latex allergy 5. History of preterm labor or incompetent cervix (requiring cerclage), short cervix (\<20mm), or uterine anomaly predisposing to preterm labor 6. Psychosocial ineligibility * Inability to reside within 30 minutes of UC Davis Medical Center or inability to maintain follow up appointments * Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate. 7. Bilateral CDH, unilateral CDH with o/e LHR \> 25% or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen 8. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome 9. Maternal contraindications to elective fetoscopic surgery 10. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery 11. Maternal isoimmunization or neonatal alloimmune thrombocytopenia 12. 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 13. No safe or feasible fetoscopic approach to balloon placement
Where this trial is running
Sacramento, California
- UC Davis Medical Center — Sacramento, California, United States (RECRUITING)
Study contacts
- Study coordinator: Amy Powne, MSN, RN
- Email: fctc@ucdavis.edu
- Phone: 916-717-4690
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.
Conditions: Congenital Diaphragmatic Hernia, Fetal endoscopic tracheal occlusion