An investment of $11.5 million is being made into a clinical trial to examine a therapy for children with brain injuries.
The trial will test the effectiveness of induced hypothermia as a therapy for brain swelling in children who have suffered severe traumatic brain injuries.
The money has been awarded to 12 centers in the U.S. to participate in the trial which will be led by the Children’s Hospital of Pittsburgh; the Children’s Medical Center in Dallas, which has a level I pediatric trauma center, will act as a local coordinating site.
The five-year trial expects to enroll a total of 340 children up to age 16, and is being funded by the National Institute of Neurological Disorders and Stroke, a component of the National Institutes of Health.
Patients eligible for the trial must have received a severe brain injury caused by blunt trauma which excludes patients who have suffered injuries that penetrate the skull such as gunshot wounds.
Patients selected to receive the hypothermia therapy will receive normal emergency care but also have their bodies cooled to between 32 and 33 degrees Celsius (89 to 90 degrees Fahrenheit), using special cooling blankets and/or cooled saline given intravenously.
They will remain cooled for 48 hours while being closely monitored in the intensive care unit and will be tracked by researchers for one year to record outcomes, with a battery of tests being conducted at six and 12 months following the injury.
Dr. Pam Okada, an associate professor of pediatrics at UT Southwestern and lead investigator of the Dallas trial, says trauma is the leading cause of death and disability in children, and constitutes more than all other causes combined.
Dr. Okada says previous studies have shown hypothermia is not only safe in children following severe traumatic brain injury, but may improve their chance of survival and children also appear to have better outcomes than adults following traumatic brain injury.
According to Dr. Okada it has been demonstrated that children younger than 4 actually have worse outcomes and problems with motor development, behavior, learning, memory and other higher-level functions are common even in children with only “moderate” or “mild” concussions or injuries.
Dr. Okada says in head injuries where the skull remains intact there is little room for swelling and this causes a diminished blood flow resulting in brain damage; by cooling the body the swelling may be reduced and ongoing damage possibly prevented.
Should the therapy prove to be effective, it would represent a major breakthrough in the treatment of traumatic brain injuries.
Federal and state laws demand that those who participate in a clinical research study must provide or, in the case of a child, have a guardian provide informed consent; due to the nature of this trial and the fact that hypothermia must be induced within six hours of injury, it may be sometimes impossible to obtain consent at the time of brain injury.
The researchers are therefore notifying the public that informed consent will be waived but every attempt to contact family members to provide notification and consent for continued participation will be made as soon as possible after enrollment.
Also participating in the trial are the Davis Medical Center at the University of California, Miami Children’s Hospital and Jackson Memorial Hospital at the University of Miami, Penn State Milton S. Hershey Medical Center, Johns Hopkins University Hospital, Duke University, Long Island University, Semmes Murphy Clinic at the University of Tennessee and Harborview Medical Center at the University of Washington.
For more information contact 214-456-8463 or visit http://www.coolkidstrial.org/