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

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.

NCT Number	NCT07166172
Lead Sponsor	Johns Hopkins University Collaborators: KARL STORZ Endoscopy-America, Inc.
Conditions	Congenital Diaphragmatic Hernia, Congenital Abnormalities, Neonatal Diseases and Abnormalities, Hernia, DIaphragmatic, Congenital, Internal Hernia, Hernia, Pathological Conditions, Anatomical, Pathological Conditions, Signs and Symptoms
Enrollment	80 participants
Start Date	2025-06-23
Primary Completion	2029-12-01 (estimated)
Study Completion	2031-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-23