Critical care pediatricians from Johns Hopkins Children’s Center are joining colleagues from 33 other hospitals in the United States and Canada to study the effects of body cooling, or hypothermia, on children who suffer a cardiac arrest.
Cardiac arrest interrupts oxygen supply to the brain, causing inflammation and cell death, which can lead to often irreversible neurological damage, the investigators say.
“This exciting new study should tell us if reducing a child’s body temperature could curb inflammation in order to minimize, even prevent, cell death and brain injury,” said study investigator Jennifer Lee-Summers, M.D., a pediatric critical care specialist at Hopkins Children’s.
The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has launched the first large-scale, multicenter study to investigate the effectiveness of body cooling treatment in infants and children who have had cardiac arrest. The Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trials total more than $21 million over six years. Therapeutic hypothermia 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, but it has not been studied in infants or children who have had cardiac arrest.
“Children who have experienced cardiac arrest can suffer long-term neurological damage or death,” said NHLBI Acting Director Susan B. Shurin, M.D., a board-certified pediatrician. “There are abundant data demonstrating the benefits of hypothermia in adults with cardiac arrest, but very limited experience in children. This study begins 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.
About 16,000 children suffer cardiac arrest each year in the United States, according to a 2008 review of pediatric cardiopulmonary resuscitation in the journal Pediatrics.
Their hearts stop pumping effectively, and blood stops flowing to their brains and other vital organs. In many cases, the outcome is death or long-term disability.
Cardiac arrest in infants and children has many causes, such as 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 temperature to 89.6-93.2 degrees Fahrenheit) and therapeutic normothermia, or normal temperature, (maintaining the patient’s temperature at 96.8-99.5 degrees 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 days, 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 involve 34 clinical centers in the United States and Canada. The C.S. Mott Children’s Hospital at the University of Michigan serves as the lead clinical center, while the data coordinating center is based at the University of Utah School of Medicine.
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.
In addition to Hopkins Children’s, the 33 other participating clinical centers across North America are:
- Children’s Hospital of Alabama, Birmingham
- Diamond Children’s Medical Center, University of Arizona, Tucson
- Phoenix Children’s Hospital
- Arkansas Children’s Hospital, Little Rock
- Children’s Hospital of Los Angeles
- Children’s Hospital of Orange County, Orange, Calif.
- Loma Linda University Children’s Hospital, Calif.
- Mattel Children’s Hospital, University of California, Los Angeles
- UC Davis Children’s Hospital, Sacramento, Calif.
- The Hospital for Sick Children, University of Toronto, Ontario
- Children’s Hospital of Denver, Aurora, Colo.
- Children’s National Medical Center, Washington, D.C.
- Children’s Healthcare of Atlanta Pediatric Hospital
- Children’s Memorial Hospital, Chicago
- Kosair Children’s Hospital, Louisville, Ky.
- Children’s Hospital of Michigan, Detroit
- C.S. Mott Children’s Hospital, University of Michigan, Ann Arbor
- Children’s Hospitals and Clinics of Minnesota, Minneapolis
- St. Louis Children’s Hospital, Washington University
- Children’s Hospital of New York, Columbia University
- Golisano Children’s Hospital, University of Rochester, N.Y.
- Cincinnati Children’s Hospital Medical Center
- University Hospitals, Rainbow Babies and Children’s Hospital, Cleveland
- Nationwide Children’s Hospital, Columbus, Ohio
- Children’s Hospital of Philadelphia
- Penn State Hershey Children’s Hospital
- Children’s Hospital of Pittsburgh
- Le Bonheur Children’s Hospital/University of Tennessee Health Science Center, Memphis
- Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville, Tenn.
- Children’s Medical Center of Dallas
- Primary Children’s Medical Center, University of Utah, Salt Lake City
- Seattle Children’s Hospital
- Children’s Hospital of Wisconsin, Wauwatosa
Founded in 1912 as the children’s hospital of the Johns Hopkins Medical Institutions, the Johns Hopkins Children’s Center offers one of the most comprehensive pediatric medical programs in the country, treating more than 90,000 children each year. Hopkins Children’s is consistently ranked among the top children’s hospitals in the nation. Hopkins Children’s is Maryland’s largest children’s hospital and the only state-designated Trauma Service and Burn Unit for pediatric patients. It has recognized Centers of Excellence in dozens of pediatric subspecialties, including allergy, cardiology, cystic fibrosis, gastroenterology, nephrology, neurology, neurosurgery, oncology, pulmonary, and transplant. For more information, please visit www.hopkinschildrens.org
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