Clinical Trial: Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:

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%).

Sponsor: University of Colorado, Denver

Current Primary Outcome: Percent of neonatal survivors at time of discharge [ Time Frame: Discharge from the hospital, an expected average of 12 weeks. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Prenatal increase in lung volume [ Time Frame: 2 weeks (prenatally) ]
  Lung volume after FETO procedure
• Number of days of Postnatal mechanical ventilator support [ Time Frame: First 28 days of postnatal life ]
  mechanical ventilator support will be monitored and recorded in days of use

Original Secondary Outcome: Same as current

Information By: University of Colorado, Denver

Dates:
Date Received: July 31, 2015
Date Started: September 2015
Date Completion: February 2023
Last Updated: August 22, 2016
Last Verified: August 2016