Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Congenital Diaphragmatic Hernias Clinical Trial

Official title: Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

Status Recruiting

Clinical Trial Summary

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Clinical Trial Description

Prenatal tracheal occlusion (TO) obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%. The goal of this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH Observed/expected lung-to-head ratio < 25%(O/E LHR < 25%). ;

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernias
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

• NCT number: NCT06064188
• Study type: Interventional
• Source: Connecticut Children's Medical Center
• Contact: Timothy Crombleholme, MD
• Phone: 860-545-9830
• Email: tcrombleholme@connecticutchildrens.org
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Completion date: December 31, 2028