Although severe traumatic brain injury is the leading cause of death for children in the United States, there is no standard way to treat it, medical experts say.
To evaluate the various treatments available for these injuries, two researchers -- from Children's Hospital of Pittsburgh of UPMC and the University of Pittsburgh Graduate School of Public Health -- have been chosen by the National Institutes of Health to lead a $16.5 million international study.
Severe traumatic brain injury -- classified as a patient being unresponsive upon arrival at a hospital -- leads to an estimated 7,000 deaths of children a year in the U.S., according to estimates by the Centers for Disease Control and Prevention. Children who suffer severe TBI generally receive their injuries in motor vehicle, bicycle and ATV accidents, falls, sports mishaps and child abuse.
The five-year study is being led by Michael J. Bell, director of pediatric neurocritical care and neurotrauma at Children's Hospital, and Stephen Wisniewski, senior associate dean and co-director of the Epidemiology Data Center at Pitt.
The researchers will enroll 1,000 children 18 years old and younger from as many as 40 medical facilities in the United States, United Kingdom, France, Spain and elsewhere to compare the effectiveness of their immediate treatment for severe TBI.
It will focus specifically on strategies to lower intracranial pressure, to treat secondary injuries and the delivery of nutrients.
Dr. Bell said the study will provide "compelling evidence" to change clinical practices, provide evidence for new recommendations for future guidelines and will lead to improved TBI research protocols that would limit variability in treatments.
"Everyone has a lot of good ideas. The variations in care between places are startling," Dr. Bell said. "Currently, there aren't any therapies standardized across the country on how to treat it.
"We're going to recruit the best places, see what they do and learn which therapies are associated with the best outcomes."
Such a study has been conducted in other fields but never before for pediatric TBI.
The study will collect data on the patients over the week following the injury. Outcomes will be tested at six months and one year after injury for all children.
"This novel study, which includes many dedicated international physicians and scientists, has the potential to accelerate our knowledge of how to treat children who sustain severe traumatic brain injuries," Ramona Hicks, a program director at the NIH National Institute of Neurological Disorders and Stroke, which is providing the grant support, said in a statement. "NINDS looks forward to rapid results that will inform clinical practice within the next few years."
"There are a number of public health strategies -- such as wearing seat belts and bike helmets -- that have reduced severe traumatic brain injury but we still don't know how to treat it when it does occur," Dr. Wisniewski said.
The start-up phase will take six to nine months before researchers begin enrolling patients for the study, he said.
He noted that "with medical advances, those who were severely injured 20 to 25 years ago might not have survived for us to actually worry about the issues we're worrying about now."
Following the progress of the patients for a year will not only show researchers the effectiveness of the clinical treatment they received but also "will advance our knowledge about how long it takes them to return to school, the quality of life they have and the impact on the family," Dr. Wisniewski said.
"Rehabilitation for walking, cognitive problems, behavior problems -- there are a number of disorders that TBI causes," Dr. Bell said. "Our hope is to find which strategies minimize those outcomes."
Michael A. Fuoco: email@example.com or 412-263-1968.