Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
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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
Experimental: Fetal Tracheal Occlusion
Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.
Device: - Fetal Tracheal Occlusion
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 as a requirement to enter the TOTAL trial.
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Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45229
Foong-Yen Lim, MD