Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

Launched by DR ERIN PERRONE · Aug 9, 2019

Keywords

ClinConnect Summary

The Fetal Endoscopic Tracheal Occlusion (FETO) Trial is looking at a new way to treat serious cases of Congenital Diaphragmatic Hernia (CDH), a condition that affects a baby's breathing. This study will involve pregnant women who are between 27 and 29 weeks along in their pregnancy and whose babies have been diagnosed with severe CDH. The goal is to see if a special balloon can be safely placed in the baby's airway to help their lungs develop better before birth. To participate, women must live within 30 miles of Michigan Medicine and have a support person available throughout the pregnancy, as there will be weekly follow-ups and some lifestyle changes required, such as not exercising or working.

To be eligible for the trial, women need to have a single baby (not twins or more), and the baby must have certain health conditions related to CDH. They also need to agree to all the study procedures and have a stable support system in place. Participants will receive close monitoring throughout the study, and all care will be provided by a specialized team at Michigan Medicine. If you or someone you know is interested in this trial, it’s important to understand these requirements and the commitment involved.

Gender

FEMALE

Eligibility 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.