HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Start Date
7/21/2020
Completion Date
8/31/2027
Summary
Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.
Detailed Description
The ESTHI Trial is a multi-center randomized controlled trial (RCT) comparing endoscopic third ventriculostomy with choroid plexus cauterization (ETV+CPC) and shunt in infants with hydrocephalus. The study will leverage the infrastructure of the Hydrocephalus Clinical Research Network (HCRN), a committed group of 14 leading North American pediatric neurosurgical centers with a long track-record of successful collaborative clinical research and RCTs in hydrocephalus. Optimal cognitive outcome is the primary concern of families and will, therefore, be the primary outcome. Assessment of dMRI, a validated, non-invasive method of measuring white matter microstructural integrity and structural connectivity in the developing brain, will provide further insight into the developmental consequences of these two treatments. The results of the RCT will help families determine the optimal treatment of hydrocephalus for their child.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)
Ventriculoperitoneal Shunt
Conditions
Locations
Children's of Alabama
Birmingham, Alabama 35233
United States
Phoenix Children's Hospital
Phoenix, Arizona 85016
United States
Children's Hospital of Los Angeles
Los Angeles, California 90027
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Yale University
New Haven, Connecticut 06520
United States
Wolfson Children's Hospital
Jacksonville, Florida 32207
United States
Arnold Palmer Hospital for Children
Orlando, Florida 32806
United States
Trustees of Indiana University
Indianapolis, Indiana 46202
United States
Johns Hopkins Children's Center
Baltimore, Maryland 21287
United States
St. Louis Children's Hospital
St Louis, Missouri 63110
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224
United States
The Pennsylvania State University
University Park, Pennsylvania 16802
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
United States
Texas Children's Hospital
Houston, Texas 77030
United States
Primary Children's Hospital
Salt Lake City, Utah 84118
United States
Virginia Commonwealth University
Richmond, Virginia 23284
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
Alberta Children's Hospital
Calgary, Alberta T3B 6A8
Canada
British Columbia Children's Hospital
Vancouver, British Columbia V6H 3V4
Canada
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
Canada