A neurosurgeon at Children's Hospital of Pittsburgh will lead a national clinical trial to determine whether the process of cooling children with severe head-trauma injuries can reduce brain swelling and long-term brain damage.

Dr. P. David Adelson, director of the Pediatric Neurotrauma Center at Children's Hospital, a University of Pittsburgh Medical Center facility, will lead researchers at 12 sites nationwide in a $11.5 million clinical trial funded by the National Institute of Neurological Disorders and Stroke.

During the five-year study, 340 children ages 16 and under who suffer severe brain trauma injuries will be studied to see if they experience improved outcomes by undergoing induced hypothermia -- the process of having their bodies cooled to 89 to 90 degrees Fahrenheit for 48 hours. Key is initiating the treatment within six hours of the injury, Dr. Adelson said.

Already it has been proven that hypothermic treatment prevents brain damage in cardiac arrest patients. Dr. Adelson said studies also have shown that newborns with deficient oxygen flow to the brain showed positive benefits after undergoing 72 hours of hypothermic treatment. Yet another study showed that young adults who suffered severe brain trauma injuries also benefited from the treatment.

A pilot trial that Dr. Adelson led at Children's Hospital looked at the safety, performance and outcomes of hypothermic treatment on young head-trauma patients, and that trial showed success. Results were published in the journal Neurosurgery in April 2005. But Dr. Adelson said the sample was too small to be conclusive, prompting the national trial.

Patients in the latest study must have severe closed-head injuries -- injuries that do not penetrate the skull -- and must receive hypothermic treatment no later than six hours after injury. Body temperature will be reduced with cooling blankets or cooled-saline intravenous injections. Injured children are sent to Children's Hospital from as far away as Erie and Central Pennsylvania, so quickness is key.

Because cooling patients already has been shown to be a safe procedure, doctors will initiate the treatment without parental consent. A vast majority of parents do consent, but treatment will be discontinued if they do not.

In closed-head trauma, where the skull remains intact, there is little room for swelling, and the result is diminished blood flow that can lead to brain damage.

Why cooling might work is not yet clear, Dr. Adelson said. But it could reduce inflammation, much like putting ice on a swollen ankle, and might reduce other cascading events that cause swelling.

"We've proven this therapy is safe," he said. "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."

For more information, visit www.chp.edu.