Advance for Directors in Rehabilitation reported on a clinical trial, funded by the National Institute of Neurological Disorders and Stroke, that will utilize induced hypothermia to reduce brain swelling in children suffering from traumatic brain injuries. The 12 medical centers that are participating are looking to enroll 340 children up to the age of 16 in the 5-year trial. Eligible individuals must have suffered from a severe brain injury caused by blunt trauma, excluding those who have suffered penetrating head injuries. While the study is not without risks, Pam Okada, MD associate professor of pediatrics at UT Southwestern states “Previous studies have shown hypothermia is not only safe in children following severe traumatic brain injury, but may improve their chance of survival”.
Researchers examine the effectiveness of induced hypothermia in children with severe TBI (2008) states:
Patients selected to receive hypothermia therapy will be cooled to between 32 and 33 degrees Celsius (89 to 90 degrees Fahrenheit), using special cooling blankets and/or cooled saline given intravenously. In addition to normal emergency care, they will remain cooled for 48 hours while being closely monitored in the intensive care unit. Children will be tracked by researchers for 1 year to record outcomes, with a battery of tests being conducted at six and 12 months following the injury.
According to federal and state laws, those who participate in a clinical research study must provide or, in the case of a child, have a guardian provide informed consent. Because of the nature of this trial and the fact that hypothermia must be induced within 6 hours of injury, it may be sometimes impossible to obtain consent at the time of brain injury.
For this reason, researchers are notifying the public that informed consent will be waived. Every attempt to contact family members to provide notification and obtain consent for continued participation will be made as soon as possible after enrollment.