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โ† Trials
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Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia

RecruitingNAAges 18 Years - 50 YearsFemaleChildren's Hospital Medical Center, Cincinnati
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In plain words

What the trial is, and whether it could suit you

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 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 Exclusion 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
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What it tests

  • Fetal Tracheal Occlusion
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Where

1 site
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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