As native Texan and Buffalo Bills running back Kevin Everett was transported off the field after sustaining an injury Sept. 9 in a game against the Denver Broncos, many wondered if he would be able to walk again. However, reports of good news continue to come from southeast Texas, where Everett is making his recovery - and many are praising the experimental treatment given the player by the medical team in Buffalo. Cold saline was used to cool Everett immediately - a process that is being studied for its expected benefit to patients with brain and nerve injury.
Children's Medical Center Dallas and the University of Texas Southwestern Medical Center at Dallas announce that the research team from the Perot Center for Brain & Nerve Injuries at Children's has been chosen to participate in the country's first hypothermia clinical trial for pediatrics, in conjunction with UT Southwestern, as one of only 12 sites in the country to investigate whether the same type of treatment given the star football player would help children who have sustained serious injury to the brain and nervous system. The study is led by Children's Hospital of Pittsburgh with $11.5 million from the National Institutes of Health to study the effectiveness of induced hypothermia as a therapy for brain swelling in children who have suffered traumatic brain injuries.
As the only Level I trauma center for pediatrics in the southwest, Children's Medical Center Dallas receives the type of injured patients that would qualify for the study. Researchers plan to enroll 340 children nationwide 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.
Patients in the study selected to receive hypothermia therapy will be cooled to between 32-33 degrees Celsius (89-90 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, measured 3, 6 and 12 months following the initiation of treatment.
According to federal and state law, those who participate in a clinical research study must provide informed consent -- or, in the case of a child, a guardian must provide consent. Because of the nature of this trial and the fact that hypothermia must be induced within six hours of injury, it may be impossible to obtain consent within the six hours from injury. For this reason, researchers are notifying the public that informed consent will be waived. The care team will make every attempt to contact family members to provide notification and obtain consent for continued participation as soon as possible after enrollment.
Trauma is the leading cause of death and disability in children, more than all other causes combined. Problems that develop with motor, behavior, learning, memory and other higher-level functions are common even in children with only "moderate" or "mild" concussions or injuries.
Many experimental, pre-clinical studies have shown that cooling of the core body and brain temperature has been helpful in lessening the damage following a brain injury. Recently, a clinical trial in newborns with hypoxic ischemic brain injury found that hypothermia significantly improved the outcomes in children who were cooled. A pilot Phase II safety and performance trial of hypothermia in children with a traumatic brain injury did not raise any issues with regard to safety. While these findings are promising, the studies were not of sufficient size to determine if the use of cooling is safe or beneficial.
We need to receive as much community feedback as possible. Please contact us with your thoughts as we embark on this important endeavor. Be sure to include your name, address, and contact information.
If you would like to “opt out” of this trial, please send us your child’s full name, date of birth, and address. Your child’s name will be added to the Do Not Enroll Registry and will not be approached for participation should he/she come to Children's Medical Center Dallas for the treatment of a traumatic brain injury.
Perot Brain & Nerve Injury Center
Children's Medical Center Dallas
1935 Motor Street
Dallas, TX 75235
Cool Kids Trial Hotline: (214) 456-8436
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