Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia (FETO)

This is an interventional supportive care trial for Congenital Diaphragmatic Hernia Read More

Inclusion Criteria:

• Maternal Age: 18-50
• Singleton gestation
• Gestational age before 29 weeks 6 days
• Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms. For severe right sided CDH o/e LHR less than 30 % between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms.
• Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS)
• Absence of associated fetal structural cardiac anomalies by a dedicated fetal echocardiogram
• Absence of other structural anomalies by ultrasound or MRI
• Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT).
• Must be willing to remain near LPCH Stanford (within 30 minutes from the hospital) for the duration of the balloon placement.
• No maternal and/or fetal contra-indications to fetal surgery such as a bleeding disorder, poorly controlled diabetes or hypertension, short cervix (measuring < 20mm), risk for preterm birth etc.
• Planned pregnancy surveillance at LPCH Stanford
• Planned delivery at LPCH Stanford
• Able to provide written consent
• Willingness to comply with all study procedures and availability (meets psychosocial criteria) for the duration of the study including having a support person

Exclusion Criteria:

• Contraindications to fetal surgery including poorly controlled hypertension, diabetes or other maternal medical condition including hematological disorder
• High risk for preterm labor and/or delivery based on either significant history of preterm birth, short cervix (measuring < 20mm), significant uterine anomaly or other risk factor, incompetent cervix (requiring cerclage)
• Non-isolated CDH - CDH with additional structural anomalies
• Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI is a calculation which includes a person's height and weight
• History of natural rubber latex allergy
• Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
• Participation in another intervention study that influences maternal and fetal morbidity and mortality.
• Bilateral CDH, left-sided CDH with O/E LHR >25%, or left-sided CDH with O/E LHR <25% but liver completely down in abdomen
• Right-sided CDH O/E LHR >30% or right-sided CDH with O/E LHR <30% with liver completely down in abdomen
• Significant placental abnormalities (abruption, chorioangioma, accreta) known at the time of enrollment and/or surgery
• 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
• No safe or feasible fetoscopic approach to balloon placement.