Children's Hospital Medical Center, Cincinnati
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected lung-to-head ratio of \<25%, LHR \<1, or a moderate category with o/e LHR \<30%, singleton pregnancy, no known other anomalies, gestational age \< 29 weeks 6 days (severe), gestational age \< 31 weeks 6 days (moderate), no maternal disease, maternal age \> 18 years old…. meet criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in our center.
Inclusion 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 echocardiogr…
Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of \<25%, LHR \<1, o/e LHR\<30% (moderate), singleton pregnancy, no known other anomalies, gestational age \< 29 weeks 6 days, no maternal disease, maternal age \> 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center.
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