Safety and Efficacy of FETO in CDH: A Phase III Trial

Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.

NCT Number	NCT06884423
Lead Sponsor	Holly L Hedrick, MD
Conditions	Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Enrollment	80 participants
Start Date	2025-04-07
Primary Completion	2030-04 (estimated)
Study Completion	2032-04 (estimated)
Updated on ClinicalTrials.gov	2026-07-22