Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia

Eligibility Criteria

• * Isolated CDH with liver up
• * Severe pulmonary hypoplasia with ultrasound O/E LHR \<25% at the time of surgery
• * Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
• * Moderate pulmonary hypoplasia with ultrasound O/E LHR \<30% and liver-up at the time of surgery
• * Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
• * Maternal age greater than or equal to 18 years
• * Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
• * Normal karyotype or FISH
• * Normal fetal echocardiogram
• * Singleton pregnancy
• * Willing to remain in the greater Cincinnati area for remainder of pregnancy
• * Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
• * Family meets psychosocial criteria
• * Patient \< 18 years old
• * Multi-fetal pregnancy
• * Rubber latex allergy
• * Preterm labor, cervix shortened (\<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
• * Bilateral CDH, isolated left sided CDH with an O/E \> 30%
• * Additional fetal anomaly by ultrasound, MRI, or echocardiogram
• * Chromosomal abnormalities
• * Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
• * Incompetent cervix with or without a cerclage
• * Placental abnormalities known at time of enrollment
• * Maternal HIV, Hepatits B, Hepatitis C
• * Maternal uterine anomaly
• * No safe or technically feasible fetoscopic approach to balloon placement
• * Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy