Cooling cap to cut infant brain damage wins US OK

Last Updated: 2006-12-21 13:00:37 -0400 (Reuters Health)

WASHINGTON (Reuters) - Babies deprived of oxygen during birth may now be treated with a cap that cools the head to prevent or reduce brain damage, U.S. health officials said on Wednesday.

Natus Medical Inc.'s Cool-Cap device may be an option for about 5,000 to 9,000 U.S. babies born each year with moderate to severe hypoxic-ischemic encephalopathy (HIE), the Food and Drug Administration said as it announced the product's approval.

The oxygen deprivation seen in HIE may trigger brain damage over a period of hours or days, researchers say. Now, up to 20 percent of newborns with HIE die and a quarter are permanently disabled, the FDA said.

Cooling the brain aims to limit damage as soon as possible. The Cool-Cap system, made by privately held Olympic Medical Corp., sends a steady flow of cool water through a cap placed on an infant's head.

Researchers studied 234 infants randomly assigned to 72 hours of treatment with the Cool-Cap or conventional care.

Fifty-five percent of the children who were treated with the brain-cooling device died or suffered severe disability by the time they were 18 months old, compared to 66 percent of the others.

"Until now, there has been no effective treatment for these infants other than supportive care," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a statement.

The Cool-Cap was developed by Olympic Medical Corp., which Natus Medical acquired in October.