RecruitingNot ApplicableNCT07166172

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia

Sponsor

Johns Hopkins University

Enrollment

80 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

Hernia Congenital Diaphragmatic Hernia Internal Hernia Neonatal Diseases and Abnormalities Congenital Abnormalities Pathological Conditions, Anatomical Hernia, DIaphragmatic, Congenital Pathological Conditions, Signs and Symptoms

Summary

This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR \< 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Fetal Treatment Arm (FETO Group) for people with congenital abnormalities, congenital diaphragmatic hernia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

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 Treatment Arm (FETO Group)

Participants will undergo FETO surgery between 27 weeks + 0 days to 29 weeks + 6 days gestation. The FETO intervention involves two procedures: (1) inserting a balloon into the fetal trachea, and (2) removing the balloon before delivery. After the first FETO procedure, participants will be monitored weekly by ultrasound. Removal of the balloon will be performed at 34 weeks + 0 days to 34 weeks + 6 days gestation. Planned delivery will occur after 37 weeks. The follow-up phase will be conducted from birth to 24 months of age.