‘Cooling Cap’ For Newborns Gets FDA Approval

The Food and Drug Administration has approved a head-cooling cap for use in treating infants deprived of oxygen at birth to prevent or reduce brain damage. According to the FDA, the Cool-Cap could cut newborn death and disability rates.

The Cool-Cap is a first-of-its-kind medical device developed by Olympic Medical Corp. that works by circulating chilled water through a special cap worn on the newborn's head.

Research

Studies have shown that cooling the body temperature slightly reduces the brain's oxygen requirements, slowing the death of brain cells that typically continues even after blood begins to flow again.

One study involving 234 oxygen-deprived infants found that babies who were treated were less likely to suffer death or disability after 18 months than those who received standard care.

Conditions of Approval

As part of the FDA approval, Olympic Medical will be required track patient progress, train and certify healthcare workers who may need to use the device, and also restrict use of the cap to newborns who meet certain criteria.

An estimated 5,000 to 9,000 babies suffer oxygen deprivation at birth. Approximately 20 percent of those babies die and another 25 percent suffer permanent brain damage. Newborns starved of oxygen also face an increased risk of developing cerebral palsy.

If your child developed cerebral palsy and you think medical malpractice may have been a factor, you may be entitled to seek compensation to help cover the care of medical treatment and more. Please contact a cerebral palsy attorney today to learn more.