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

Eligibility 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; results by fluorescence in situ hybridization (FISH) will be acceptable if patient is \>26 weeks
• 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 NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) and ability to maintain follow up appointments. NYP/CUIMC will work with the study participant to assist in securing housing 30 minutes from the hospital if this is a challenge to her.
• * 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 NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC)
• * Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work
• 1. Multi-fetal pregnancy
• 2. History of latex allergy
• 3. History of preterm labor or incompetent cervix (requiring cerclage), short cervix (\<20mm), or uterine anomaly predisposing to preterm labor
• 4. Psychosocial ineligibility
• * Inability to reside within 30 minutes of NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) 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.
• 5. Bilateral CDH, unilateral CDH with o/e LHR \> 25%, or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen
• 6. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
• 7. Maternal contraindications to elective fetoscopic surgery
• 8. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
• 9. Maternal-fetal Rh 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
• 10. No safe or feasible fetoscopic approach to balloon placement
• 11. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
• 12. Participation in another intervention study that influences maternal and fetal morbidity and mortality.