FDA approves infant cooling cap

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 last week.

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, the Food and Drug Administration said as it announced the product’s approval.

The oxygen deprivation seen in the condition may trigger brain damage over a period of hours or days, researchers say. Now, up to 20% of affected newborns die and 25% 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 system 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 with 66% of the others.