RecruitingNot ApplicableNCT02986087

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


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

40 participants

Start Date

Nov 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a procedure called FETO (fetal endoscopic tracheal occlusion) — a surgery performed on a baby still in the womb — for babies with a serious birth defect called congenital diaphragmatic hernia (CDH), where organs from the belly push into the chest and prevent the lungs from growing properly. **You may be eligible if...** - You are pregnant with a baby diagnosed with CDH (no other major birth defects present) - The baby's liver is displaced into the chest - The baby's lung measurements on ultrasound show severe or moderate underdevelopment - The procedure would be performed between 27 and 31 weeks of pregnancy - You are the mother and are 18 years of age or older **You may NOT be eligible if...** - Your baby has other major birth defects in addition to CDH - The timing or severity of the condition falls outside the criteria for the procedure - There are signs that the baby or mother needs immediate delivery - You are past 29 weeks 6 days of pregnancy at the time of enrollment (for the severe group) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFetal 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.


Locations(1)

Cincinnati Children's Hospital Medical Center (CCHMC)

Cincinnati, Ohio, United States

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NCT02986087


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