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Press Releases New York Presbyterian Hospital Columbia-Presbyterian Campus 161 Fort Washington Avenue New York, NY 10032 Contact: Karin Eskenazi (212) 305-5587 Office of Public Affairs “LET COOLER HEADS PREVAIL” Columbia Presbyterian Center Researchers to Evaluate Brain-Cooling Therapy for Babies Deprived of Oxygen at Birth NEW YORK, NY, March 26, 1999 -- Babies who experience oxygen deprivation at birth--perinatal asphyxia--are at very high risk for serious neurological complications and even death. Investigators at the Columbia Presbyterian Center of New York Presbyterian Hospital are currently participating in the evaluation of the first possible rescue therapy for these at-risk infants--using carefully controlled cold-water cooling of their heads. Two hundred infants with perinatal asphyxia will be enrolled at 22 medical centers throughout the United States, Canada, England, and New Zealand. Ten infants will be enrolled over 18 months at the Columbia Presbyterian Center, one of two sites in the New York metropolitan area to participate in the study. Infants will be randomized within six hours of birth either to a head-cooling group with mild whole-body hypothermia or to a non-cooling group. Those in the non-cooling group will receive standard neonatal intensive care. Infants who receive brain cooling will have a cap fitted around their scalp through which cool water (8° to 10° C) will flow. The core temperature of the infant will be controlled by an adjustable overhead heater that will maintain rectal temperature at a lower (34-35° C) but safe range (normal rectal temperature is 37° C). It takes about 30 minutes for the target temperature to be reached.Rectal, nose, scalp, and abdominal temperatures will be continuously measured. Cardiovascular and pulmonary function, as well as blood-clotting status, will be closely monitored. Cooling will be maintained for 72 hours, followed by slow rewarming. During the recovery phase, the cooling cap will be removed and the overhead heater adjusted so that the rectal temperature increases by no more than 0.5° C per hour. Neurodevelopmental assessments will be made at 6 and 18 months post-treatment. The study investigators hope to follow the infants to age six or eight in order to identify minor cognitive or learning disabilities. About four out of every 1,000 full-term babies in the United States suffer perinatal asphyxia. Causes include compression of the umbilical cord, impaired maternal-fetal blood flow, and premature separation of the placenta from the uterine wall. Because of the lack of successful intervention strategies, consequences can be as severe as seizures, learning disabilities, cerebral palsy, mental retardation, or death. The therapy under investigation, head cooling, is thought to prevent neurological damage because it may reduce brain swelling and intracranial pressure, as well as decrease programmed cell death (apoptosis). Hypothermia is also believed to reduce the production of nitric oxide and certain amino acids that can cause brain injury. “Perinatal asphyxia is one of the major problems in neonatology for which there is no current treatment,” says Richard A. Polin, MD, Director of the Division of Neonatology at Babies & Children’s Hospital of the New York Presbyterian Hospital and Professor of Pediatrics at the Columbia University College of Physicians & Surgeons. Dr. Polin is also the principal investigator for the study at the Columbia Presbyterian Center and a member of the study’s scientific advisory committee. “We hope that head cooling will successfully and safely prevent, and not merely delay, neurological problems from developing in these babies,” he adds. “There’s a relatively small therapeutic window of opportunity for these babies. They must be started on the cooling therapy within 6 hours of birth. Ideally, we would like to see them treated within two to three hours of birth. With standard treatment infants who have suffered a severe depravation at birth have about a 70 percent chance of developing injury to their brains. With the brain-cooling treatment, we hope that risk will be reduced to about 40 percent,” says Dr. Polin. “It’s very important that these babies be very carefully rewarmed, otherwise there are potential complications. Likewise, the cooling must be very controlled throughout the study. It’s not merely a matter of making these infants colder. Careful management of both the cooling and rewarming processes is integral to reducing mortality and morbidity,” notes Dr. Polin. There is much evidence to support the concept of cold-water cooling to reduce brain injury, according to Dr. Polin. A recent preliminary safety study of brain cooling with mild whole-body hypothermia in infants following perinatal asphyxia in England and New Zealand reported no adverse effects. Other studies have shown the effectiveness of brain hypothermia in reducing neurological injury in adults after head injury. In addition, whole-body cooling has been safely used for many years in babies undergoing cardiac surgery. “The infants in this study are at substantial risk for very serious neurological problems. That causes problems for the parents as well; it’s a very heavy emotional and financial burden caring for a disabled child. And society is affected as well: the lifetime cost of caring for a single disabled child approaches one million dollars. We hope that this brain-cooling therapy will prove to be an enormously valuable treatment option,” concludes Dr. Polin.