A University of Michigan C.S. Mott Children’s Hospital researcher will lead a $21 million, large-scale, multicenter study investigating the effectiveness of body cooling treatment in infants and children who have had cardiac arrest — the first such study of its kind.
Frank W. Moler, M.D., professor in the Department of Pediatrics and Communicable Diseases at the University of Michigan, will lead the clinical portion of the trials while the University of Utah School of Medicine will serve as data coordinating center.
Also known as the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials, the work will be conducted over a six-year period in 34 clinical centers in the United States and Canada in conjunction with the National Heart, Lung, and Blood Institute, one of the National Institutes of Health.
Therapeutic hypothermia, or body cooling, has been successfully used in adults after cardiac arrest and in newborn infants after birth asphyxia, or lack of oxygen, to improve survival and outcomes. Until now, researchers had not studied on a large scale the impact of body cooling in infants or children who have had cardiac arrest.
“These trials are addressing the question: What is the optimal temperature for an infant or child after cardiac arrest?” says Moler. In previous studies exploring therapeutic hypothermia, the comparison or control groups did not receive therapeutic normothermia to prevent fever.
“Children who have experienced cardiac arrest can suffer long-term neurological damage or death,” says NHLBI acting director Susan B. Shurin, M.D., a board-certified pediatrician. There are abundant data that show the benefits of hypothermia in adults with cardiac arrest, but very limited experience in children, she adds.
The THAPCA trials begin to assess the effectiveness of therapeutic hypothermia in children, and should lead to evidence-based guidelines that will optimize both quality and rates of survival.
During body cooling treatment, THAPCA participants lie on mattresses and are covered with blankets. Machines circulate water through the blankets and mattresses to control the participants’ body temperatures. Researchers do not yet know how body cooling will affect participants, since many factors can contribute to brain injury after cardiac arrest. However, they believe body cooling could provide several benefits, including less inflammation and cell death.
According to a 2008 review of pediatric cardiopulmonary resuscitation in the journal Pediatrics, about 16,000 children suffer cardiac arrest each year in the United States.
When hearts stop pumping effectively, blood stops flowing to the brain and vital organs. In many cases, the outcome is death or long-term disability. Cardiac arrest in infants and children can be caused by strangulation, drowning, or trauma. It can also be a complication of many medical conditions.
The THAPCA centers enroll participants in one of two randomized, controlled clinical trials. One evaluates participants who suffered cardiac arrest outside the hospital, while the other evaluates participants who suffered cardiac arrest in the hospital. Within each trial, there are two active treatment groups: therapeutic hypothermia (cooling the patient to 89.6-93.2 Fahrenheit) and therapeutic normothermia (maintaining the patient at 96.8-99.5 Fahrenheit). Both trials are trying to reduce fever, which commonly occurs after cardiac arrest and can lead to more severe outcomes.
Participants in the THAPCA trials must be older than 48 hours and younger than 18 years and must be enrolled in the study within six hours of suffering cardiac arrest. Once a parent or guardian provides consent, the participant is randomly assigned to one of the two treatment groups. The therapeutic hypothermia group in each trial receives the hypothermia treatment for two days and then normothermia treatment for three days, which ensures that the body temperature is kept within a normal temperature range. The patients in the therapeutic normothermia groups receive normothermia treatment for all five days.
After the five-day period, the clinical care team will continue to provide study participants with optimal medical care. Participants will undergo neurological and behavioral testing a year after the cardiac arrest.
The THAPCA trials are being conducted in partnership with the Collaborative Pediatric Critical Care Research Network, established in 2004 by the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the Pediatric Emergency Care Applied Research Network, established in 2001 by the Health Resources and Services Administration’s Maternal and Child Health Bureau.
More information about the THAPCA trials (NCT00880087 and NCT00878644) can be found at http://clinicaltrials.gov/. To interview an NHLBI spokesperson, contact the NHLBI Communications Office at 301-496-4236 or firstname.lastname@example.org. To interview Dr. Frank W. Moler, contact Margarita Bauza Wagerson, University of Michigan Health System at 734-764-2220 or email@example.com. To interview Dr. J. Michael Dean, contact Phil Sahm, University of Utah Health Sciences Public Affairs Office at 801-581-2517 or firstname.lastname@example.org.
More at www.thapca.org.
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