Children's is a Premier Center In Brain-Cooling Trial
from The Children's Hospital (TCH) News, May 2005
The Children’s Hospital recently participated in
a multi-center international clinical trial studying
the effect of cooling the brains of babies who
were deprived of oxygen at birth.
The Children’s Hospital was one of the premier centers in an international 25-center clinical trial that studied the effect of cooling the brains of babies who were deprived of oxygen at birth, said Jan Paisley, MD.
TCH enrolled more patients in the CoolCap trial than any other site, including centers across the U.S. and in New Zealand, the United Kingdom and Canada, said Dr. Paisley, a neonatologist at TCH and co-principal investigator in the trial. Children’s enrolled 23 of the 234 total newborns in the trial, which began in July of 1999 and ended in 2002.
In the trial, a water-filled cap was placed on the heads of some oxygen-deprived term newborns to see if lowering their temperatures would reduce brain damage. Oxygen deprivation – or perinatal asphyxia – occurs in approximately one to four babies per 1,000 term births and can cause mental retardation, epilepsy, hearing and vision loss and cerebral palsy, Dr. Paisley said.
One hundred and eighteen of the babies in the trial were placed in a control group and received standard clinical care. The other 116 newborns were fitted with a CoolCap for 72 hours within six hours of birth, and their core temperatures were maintained between approximately 93 degrees and 95 degrees Fahrenheit (34 to 35 degrees Celsius), Dr. Paisley said. The surviving babies received comprehensive follow-up care at 18 months, including a neurological exam, visual and auditory assessment and neurodevelopmental testing.
The results were promising: the babies with less severe initial neurological damage treated with the CoolCap showed a significant reduction – approximately 30 percent – in the rates of death and severe disability at 18 months.
“The cap cut the combined rate of disability and death from 66 percent to 48 percent,” Dr. Paisley said.
The babies with the most severe initial neurological damage – measured with an EEG cerebral function monitor – showed an approximately 20 percent reduction in death and severe disability.
“All of our cooled babies who survived are doing well, with none showing evidence of moderate or severe disabilities thus far,” Dr. Paisley said.
Dr. Paisley credits the success of the CoolCap study at Children’s to Lucy Fashaw, General Clinical Resource Center (GCRC) coordinator, co-principal investigator Adam Rosenberg, MD, and co-investigators Dan Hall, MD, and Sue Townsend, MD.
Dr. Paisley also credits the nursing and neonatology staff in the Newborn Center , the referring practitioners and physicians in the region, and the rapid response of the transport team.
Once the trial closed, Olympic Medical, which manufactures the CoolCap and sponsored the trial, received approval for a continuation protocol. This allows all eligible babies to be cooled without randomization, Dr. Paisley said. The results were published in The Lancet in January.
She expects the CoolCap to receive FDA approval in the next few months.
The trial’s results may hold promise for other areas of medicine as well, she said, including use of the therapy for adults and children who suffer from acute oxygen deprivation of the brain, which could be caused by cardiac arrest, drowning or severe head injury.
