Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia

The goal is to study the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH). The pilot study will determine whether FETO therapy can be performed safely and whether it can increase survival and decrease morbidity in the fetus when compared to standard prenatal care for the treatment of severe left congenital diaphragm hernia.

What is the purpose of this study?
The purpose of the study is to determine the feasibility and safety of performing fetoscopic endoluminal tracheal occlusion in pregnant women whose pregnancy is affected by severe left diaphragmatic hernia.

Where is this study being conducted?
The University of Texas Health Science Center Houston is one of the sites in the United States taking part in this international clinical trial.

Who is the sponsor of the study?
Dr. Anthony Johnson at The University of Texas Health Science Center Houston is the clinical trial sponsor.

Why should I participate in this study?
Your participation may help determine the best therapeutic approach for pregnant women whose pregnancy is affected by diaphragm hernia. We are hoping that intervention may improve lung development so that the baby’s prognosis may be better.

What happens to me if I participate in the study?
If you decide to take part in the study you will undergo fetal intervention, known as FETO procedure. The FETO procedure involves placing a tiny balloon in the baby’s trachea. Babies do not use the trachea to breathe before they are born. Normally, the baby’s lungs produce fluid, which escapes through the trachea and mouth into the baby’s sac. If there is a balloon in the trachea the fluid produced by the lungs remains within the lungs, thus increasing pressure in the lungs, which will then expand and possibly stimulate lung growth.

Is compensation available for participation?
At this time there is no compensation for participation in the study.

Who can I contact for more information about this study?
Please contact The Fetal Center at (832) 325-7288 and ask for the Senior Research Scientist, Jeannine Garnett.