Fetal Endoscopic Tracheal Occlusion for CDH (CDH)

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Jun 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat a serious condition called Congenital Diaphragmatic Hernia (CDH) in unborn babies. CDH happens when a baby’s diaphragm, the muscle that helps them breathe, doesn’t develop properly, which can lead to breathing problems after birth. The trial will focus on using a special procedure called Fetal Endoscopic Tracheal Occlusion (FETO), where a small balloon is placed in the baby’s trachea to help improve lung development. This study is taking place at UC Davis Medical Center and is currently recruiting pregnant women who are between 27 and 29 weeks along in their pregnancies and meet specific health criteria.

To participate, women need to be 18 years or older, have a single baby, and live within 30 minutes of the medical center for regular appointments. They must also have a support person available for help during the pregnancy. Participants will need to adjust their daily activities, as they will not be able to exercise, work, or have sexual intercourse during the study. The goal of this trial is to see if this procedure is safe and effective, and it will provide valuable information for future treatments of CDH.

Gender

FEMALE

Eligibility 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