The U and the University of Michigan will begin the first large-scale study of children who have suffered cardiac arrests.
The six-year-long trials, which begin Sept. 1, will investigate whether or not inducing hypothermia in children will prevent or reduce the brain damage they might suffer from a lack of oxygen after they’ve had cardiac arrest, according to a U press release.
During cardiac arrest, the heart stops beating, interrupting the flow of the blood that carries oxygen to the rest of the body. The lack of oxygen in the brain can lead to severe brain damage in children. A toxic chemical is also released and attacks the already weakened brain, said Brittan Browning, the study’s program director.
“The thinking is that by cooling the body and then bringing it back up to normal temperature will release the toxic chemicals without overloading the brain,” Browning said.
The study will specifically involve children who suffered from an accident, such as near-drowning, or an underlying medical condition which caused cardiac arrest.
The children who qualify will be randomly divided into two separate groups. The first group will have their body temperatures lowered to 32 to 34 degrees Celsius and kept at that level for 48 hours. Following the induced hypothermia, their body temperature will be raised and held at normal temperature for five days.
The second group will be held at normal body temperature, 36 to 37.5 degrees Celsius, to prevent fever for five days, Browning said.
Before the trial, the children will undergo neurological assessments to determine brain function and see if there were any previous mental retardations, Browning said. Three months after the trial, the children will be assessed again to see if they were able to maintain brain function and carry out everyday tasks.
“These kids have devastating outcomes, sometimes resulting in death,” Browning said.
The trials will be the first study of its kind done in pediatrics. A previous study involving adults had produced results that found cooling does work in preventing further brain damage. However, instead of keeping the body temperature at normal, the patients had just been left alone and many had developed a fever, which is already damaging to the brain, Browning said.
The fevers could have made the results unclear as to whether the cooling had been effective, or if the fever was the cause of further damage.
The trials will start with 15 clinical centers for the first year. Affter successful completion, the number of centers will increase to 30 and will enroll 900 children who suffer from cardiac arrest during the following five years.
The C.S. Mott Children’s Hospital at the University of Michigan will be the lead clinical center and the University of Michigan will be in charge of the conduction of the trials and patient care. The U School of Medicine will collect and analyze the data and ensure uniformity.
The National Heart, Lung and Blood Institute, part of the National Institutes of Health, will fund the trials.
“If this works, it would be easy to do an intervention and could be done at any PICU,” Browning said. “We could really save some lives with this study.”
For more information visit THAPCA’s Web site: www.thapca.org/index.html