New York, NY (May 7, 2004) -- A head-cooling device called CoolCap prevents brain damage in some oxygen-deprived newborn babies, providing the first evidence in humans that many birth-related neurological problems can be reversed, according to an international multi-center clinical trial that included physician-scientists at Morgan Stanley Children's Hospital of NewYork-Presbyterian, the only New York City medical center to participate in the study. The results were presented this week at the annual meeting of the Society for Pediatric Research in San Francisco.
Using brain wave analysis at birth, researchers identified those babies who might benefit from treatment. In the group of infants with moderate to severe injury, the percentage of babies that experienced an unfavorable outcome (death or neuro-developmental disability) was significantly reduced from 66 percent to 48 percent by the cooling. In addition, there was a trend to a reduction in mortality in the cooled infants.
"While more research is needed, the findings offer hope that this condition -- which affects thousands of babies worldwide -- might be treatable," says Dr. Richard Polin, director of the Neonatal Intensive Care Unit at Morgan Stanley Children's Hospital of NewYork-Presbyterian and professor of Pediatrics at Columbia University College of Physicians & Surgeons. Dr. Polin was a member of the study's Scientific Advisory Committee.
The CoolCap regulates the temperature of the infant's head by circulating cold water inside a thin plastic cap that is held in place by a fabric hat. Using water temperatures between 50 and 59 degrees Fahrenheit, the infant's normal body temperature is cooled to 94 degrees. Dr. Polin explains that while it is not yet understood how the treatment works, factors may include reducing brain metabolism, reducing brain inflammation, preventing brain-cell death, and reducing potentially harmful toxins released after brain injury.
As part of the study, randomized infants were fitted with the CoolCap for 72 hours. A daily neurological examination was performed for the first 72 hours, then repeated at one week, and again at the time of discharge. At 18 months, infants had a neurological assessment by a pediatrician and developmental assessment by a psychologist, as well as visual and auditory testing.
Between one and two of every 1,000 newborn babies are at risk of brain damage during the birth process. Those who survive can be left with conditions such as cerebral palsy or cognitive impairment.
The CoolCap is manufactured by Olympic Medical Corp of Seattle. The company sponsored the trial.