Fetal endoscopic treatment for congenital diaphragmatic hernia
Fetal Endoscopic Tracheal Occlusion Trial for Congenital Diaphragmatic Hernia (CDH)
This study is testing a new procedure using a special balloon to treat severe congenital diaphragmatic hernia in unborn babies to see if it is safe and effective for pregnant women with certain conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT04052828 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the feasibility and safety of using Fetal Endoscopic Tracheal Occlusion (FETO) with a detachable balloon to treat severe congenital diaphragmatic hernia (CDH) in fetuses. Pregnant women with singleton pregnancies and specific fetal conditions will undergo the FETO procedure between 27 and 29 weeks of gestation. The study will monitor participants closely, requiring them to live within 30 miles of the treatment center for regular follow-up appointments until delivery.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with singleton pregnancies and severe pulmonary hypoplasia due to congenital diaphragmatic hernia.
Not a fit: Patients with major structural cardiac defects or those not meeting the specific inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could 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 fetal interventions for congenital conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed and dated consent * Stated willingness to comply with all study procedures and availability for the duration of the study * Singleton pregnancy * No pathogenic variants on microarray or pathologic findings on karyotype * Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects * Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as observed-to-expected (o/e) lung to head ratios (LHR) \<25% with liver up * 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 * Meets psychosocial criteria * Willing to reside within 30 minutes of Von Voigtlander Women's Hospital 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 Von Voigtlander Women's Hospital * Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work. Exclusion Criteria: * Multi-fetal pregnancy * History of latex allergy * History of preterm labor or incompetent cervix (requiring cerclage), short cervix (≤20mm), or uterine anomaly predisposing to preterm labor * Bilateral CDH, unilateral CDH with o/e LHR \> 25%, or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen * Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome * Maternal contraindications to elective fetoscopic surgery * Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery * Maternal isoimmunization or neonatal alloimmune thrombocytopenia * 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 * 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.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Erin Perrone, MD — University of Michigan
- Study coordinator: Erin Perrone, MD
- Email: eperrone@med.umich.edu
- Phone: 734-936-8464
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.