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

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.