Clinical Trial: Percutaneous Endoscopic Tracheal Plug/Unplug for CDH

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Percutaneous Endoscopic Tracheal Plug/Unplug for Congenital Diaphragmatic Hernia

Brief Summary: 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.

Detailed Summary:
Sponsor: University of California, San Francisco

Current Primary Outcome: Fetal lung growth due to successful fetal tracheal occlusion/unocclusion, as determined by serial LHR measurements [ Time Frame: Between 26 and 34 weeks gestation ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Neonatal survival at 90 days of life. [ Time Frame: 90 days post-delivery ]

Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: October 6, 2008
Date Started: October 2008
Date Completion: December 2017
Last Updated: November 1, 2016
Last Verified: November 2016