Posted on 06/17/2005 3:04:31 PM PDT by TheOtherOne
Newborn 'cooling Cap' to Fight Brain Damage Nearing Market
Published: Jun 17, 2005 WASHINGTON (AP) - A device that chills newborns' brains moved a step closer to the market Friday: The government's scientific advisers ruled the Cool-Cap may help stave off brain damage in certain infants deprived of oxygen at birth.
But the Food and Drug Administration advisers said Olympic Medical Corp.'s Cool-Cap would have to be sold under careful conditions to be sure the emerging technology really helps.
The FDA isn't bound by its advisers' recommendations but typically follows them.
Research shows that mild hypothermia - cooling the body just a few degrees - can significantly improve the odds of an adult's full recovery after cardiac arrest. It reduces the brain's need for oxygen, and slows a vicious chain reaction that continues to kill brain cells once blood flow resumes.
Based on that success, scientists now are studying if chilling could help other patients with brain-harming conditions, such as children's head injuries.
The Cool-Cap marks an attempt to bring hypothermia treatment to the tiniest patients yet, newborns deprived of oxygen during birth.
A thermos-like hat with water channels running through it is strapped to the baby's head. Cold water rushes through the cap for 72 hours, bringing the baby's body temperature down to 94 degrees. Then the infant is rewarmed.
Researchers studied 218 full-term newborns who were deprived of oxygen during birth. Of those babies, 45 percent treated with the Cool-Cap just after birth survived without serious brain damage, compared with 34 percent of babies given standard care.
FDA's advisers voted 5-1, with one abstention, that the Cool-Cap should be approved, under certain conditions, said FDA's Dr. Aron Yustein. They are:
-Seattle-based Olympic Medical must provide a training program for all Cool-Cap users, and keep a registry of treated babies to continue studying the device's effects.
-The device should be used only in the type of babies studied so far.
That's because even mild hypothermia can cause side effects. Olympic Medical reported minor heartbeat irregularities in some of the babies treated.
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On the Net:
Food and Drug Administration: http://www.fda.gov
AP-ES-06-17-05 1751EDT
Any truth to the rumor that the cap was rushed to aid Sen. Dick 'Pol Pot' Durbin?
Any chance this can be enlarged and used as a hangover cure?
Google instructions for "cool ties". Find someone to create a pattern to suit your needs. That may help the hang over. I'd look it up, but it's time to go home.
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