Percutaneous Endoscopic Tracheal Plug/Unplug for CDH

STATUS: Active, not recruiting

SPONSORS:
University of California, San Francisco

Purpose

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Official Title

Percutaneous Endoscopic Tracheal Plug/Unplug for Congenital Diaphragmatic Hernia

Eligibility

Ages Eligible for Study: 18 Years - N/A

Genders Eligible for Study: Female

Health Volunteers Accepted? Accepts Healthy Volunteers

Location and Contact Information

University of California, San Francisco Fetal Treatment Center ()
San Francisco, California
94143
United States

More Information

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.