STATUS: Active, not recruiting
University of California, San Francisco
Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm. Herniation of viscera into the chest prevents the fetal lungs from developing and growing to normal size. In the most severe cases, there is significant morbidity and mortality at birth. For these fetuses, fetal intervention may improve outcomes by enabling the lungs to grow enough in utero that they are capable of sustaining life after birth. This unblinded, non-randomized trial will assess the safety and efficacy of the use of the Goldvalve balloon and MiniTorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat severe CDH in utero. The primary outcome variable will be fetal lung growth due to successful 'plugging/unplugging' of the trachea, as determined by serial lung-head ratio (LHR) measurements. Secondary outcome variables include maternal, fetal and neonatal variables, specifically neonatal survival at 90 days of life. For infants who survive beyond 90 days post-delivery, their families will be offered follow-up (up to 2 years of age and possibly beyond) in the Long-term Infant-to-Adult Follow-up Evaluation (LIFE) Clinic at UCSF.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percutaneous Endoscopic Tracheal Plug/Unplug for Congenital Diaphragmatic Hernia
Ages Eligible for Study: 18 Years - N/A
Genders Eligible for Study: Female
Health Volunteers Accepted? Accepts Healthy Volunteers
University of California, San Francisco Fetal Treatment Center ()
San Francisco, California
Study ID Numbers: 10-01765, TO CDH
Date study started: October 2008
For additional information, visit ClinicalTrials.gov.
ClinicalTrials.gov processed this data on May 26, 2015
This directory includes clinical trials that involve researchers at UCSF Medical Center. The information was obtained from ClinicalTrials.gov, a database of the U.S. National Institutes of Health.