PITTSBURGH May 17, 2007 A renowned Children's Hospital of Pittsburgh of UPMC neurosurgeon will lead a $11.5 million National Institutes of Health-funded clinical trial examining the effectiveness of induced hypothermia as a therapy for brain swelling in children who have suffered traumatic brain injuries.
P. David Adelson, MD, director of the Pediatric Neurotrauma Center at Children's and the A. Leland Albright Professor of Neurosurgery at the University of Pittsburgh School of Medicine, will lead researchers at 12 sites throughout the country.
Researchers plan to enroll 340 children up to age 16 in the five-year, Phase III randomized trial, which is being funded by the National Institute of Neurological Disorders and Stroke. In Pittsburgh, Children's will serve as the clinical site for the study and Pitt will serve as the coordinating site.
A previous Phase II clinical trial of induced hypothermia therapy led by Dr. Adelson at Children's found that moderate hypothermia therapy is safe and may potentially improve outcome. Results of that study were published in the journal Neurosurgery in April 2005.
"We've proven this therapy is safe. Now if we can determine that it is effective, it would be a major breakthrough because currently there are very limited treatments that improve outcome following traumatic brain injury in children," Dr. Adelson said. "The belief is that cooling impacts the cascade of events that leads to brain swelling. Reducing brain swelling potentially could prevent further injury."
Patients in the study selected to receive hypothermia therapy will be cooled to between 3233 degrees Celsius (8990 degrees Fahrenheit), using special cooling blankets and/or cooled saline injected intravenously. They will be cooled for 48 hours and then followed by researchers for one year to track outcomes, with a battery of tests being conducted at six and 12 months following injury.