| ■ Newborn Cooling Cap Approved by FDA | 06.12.26 |
| A head-cooling device designed to prevent or reduce brain damage in babies starved of oxygen at birth was approved Wednesday by the U.S. Food and Drug Administration. The Cool-Cap, made by Olympic Medical Corp. of Seattle, maintains a constant flow of chilled water around a newborn's head. Research has shown that cooling can reduce the brain's need for oxygen and slow a chain reaction that continues to destroy brain cells once blood flow resumes, the Associated Press reported. The FDA approval is based on a study of 234 infants deprived of oxygen at birth. At 18 months, babies treated with the Cool-Cap had lower rates of death and severe disability than infants who received standard supportive care. According to the FDA, the Cool-Cap could reduce the incidence of death and disability among the 5,000 to 9,000 infants who are starved of oxygen at birth each year in the United States. Currently, as many as 20 percent of such infants die and 25 percent suffer permanent brain damage, the AP reported. ----- Yahoo HealthDay |