Traumatic Brain Injury: Hypothermia TBI Treatment Trials Begin

The Children's Hospital of Pittsburgh plans to lead a $11.5 million National Institutes of Health-funded clinical trial that will look at induced hypothermia as a treatment for brain swelling in children who have suffered from traumatic brain injuries.

Clinical Trial of Hypothermia To Treat Pediatric Brain Injury

Research will be conducted at 12 sites throughout the country. 340 children up to the age of 16 will be enrolled in the five-year, Phase III randomized trial. A Phase II study of induced hypothermia discovered that the therapy is safe and has potential to improve outcome. P. David Adelson, who lead the Phase II study and who also will lead the Phase III study, says that hypothermia treatment is showing promise as a treatment. "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."