updated 10/3/2007 7:00:47 PM ET 2007-10-03T23:00:47

Kids who suffer severe brain injuries in North Texas may get cool saline pumped through their veins as part of a clinical trial that aims to prove that the treatment means fewer deaths and better brain function following injury.

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Children's Medical Center Dallas, in conjunction with the University of Texas Southwestern Medical Center, will be one of 12 sites across the nation participating in the five-year trial.

Cooling therapy is also being tried in stroke and spinal cord injury patients. Last month, Buffalo Bills football player Kevin Everett was treated with cold saline after a severe spinal cord injury, and he has regained some movement while recuperating in Houston.

Researchers plan to enroll 340 children up to age 16 in the randomized trial being led by Children's Hospital of Pittsburgh and funded by the National Institute of Neurological Disorders and Stroke.

Patients chosen to get the hypothermia therapy will be cooled to 89 to 90 degrees Fahrenheit by using cooling blankets and/or cool saline injected intravenously for 48 hours. Researchers will follow patients for a year, conducting tests at six and 12 months after injury.

"This is thought to potentially be a protective treatment," said Dr. Pete Stavinoha, who will be following up with the patients at Children's Medical Center Dallas.

Stavinoha said that during the follow-ups he'll be looking at a variety of functions including intelligence, language skills, capacity for learning, visual abilities, behavior and emotional function. Eventually, they will compare the outcomes in the children who received the cooling treatment to those who did not.

The previous phase of the study, which did not involve Children's, determined the cooling was safe and might improve outcomes.

By studying the results of a larger sample size in this phase — the previous phase only had 75 patients — doctors hope to get more definitive results, said the leader of the study, Dr. P. David Adelson, a professor of neurosurgery at the University of Pittsburgh.

"If this shows definitely that it lowers mortality, it would be come standard of care," said Adelson, who added that some hospitals are already using the therapy.

The thought is that by reducing brain swelling in children, the cool saline will not only help more children survive such brain injuries, but will also help lessen damage to the brain.

"The longer the child has brain swelling, the worse the outcome," said Dr. Pam Okada, one of the lead investigators on the trial in Dallas.

Adelson said hospitals can begin entering patients in this new phase Nov. 1. Okada said the trial is expected to begin in Dallas around the first of the year.

Because the hypothermia must be induced within six hours of the injury, consent to participate in the trial will be waived.

Copyright 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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