RecruitingNot ApplicableNCT05771688

Fetoscopic Endoluminal Tracheal Occlusion

Fetoscopic Endoluminal Tracheal Occlusion for Severe Left-sided Congenital Diaphragmatic Hernia


Sponsor

Children's Hospitals and Clinics of Minnesota

Enrollment

10 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

Congenital diaphragmatic hernia (CDH) is a birth defect where abdominal organs herniate into the chest, preventing the lungs from developing fully. Severe CDH carries a high mortality risk. A fetal surgery procedure called FETO (fetoscopic endoluminal tracheal occlusion) involves placing a small balloon in the baby's airway before birth to stimulate lung growth by preventing fluid from escaping. This study offers and evaluates FETO for fetuses with severe left-sided CDH. The study is open to pregnant women aged 18 and older carrying a singleton fetus with a severe left-sided CDH (defined by lung-to-head ratio below 25%), without other lethal abnormalities, between 27 and 30 weeks of pregnancy, with a cervix length greater than 20mm, and who can relocate to within 15 minutes of the treating center for the duration of the balloon placement. Psychosocial readiness (support system, no illicit drug use) is also required. Twin pregnancies, right-sided CDH, maternal HIV or active hepatitis, short cervix, and inability to consent are among the exclusions. The procedure is performed in a specialized fetal surgery center. Participants must live near the center while the balloon is in place and return for its removal. This research matters because CDH with severe lung underdevelopment has a survival rate below 25% without intervention, and FETO represents one of the few options to give these babies a fighting chance.

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

DEVICEFETO therapy

placement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days


Locations(1)

Midwest Fetal Care Center

Minneapolis, Minnesota, United States

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NCT05771688


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