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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, United States
RECRUITINGChange lung growth on prenatal imaging
Change in o/eLHR and other prenatal imaging tests
Time frame: prenatal period up to 40 weeks gestation
Change survival in the severe congenital diaphragmatic hernia subgroup
Change rate of survival
Time frame: 6 months
Change need for ECMO therapy
Change need for ECMO therapy
Time frame: 6 months
Change pulmonary hypertension
Change pulmonary hypertension
Time frame: 6 months
Change neonatal morbidity
Change neonatal morbidity
Time frame: 1 year
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