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MEDICAL: CONDITIONS: CARDIAC ARREST :
CHILDREN: HEALTH AND MEDICAL : 
MEDICAL: RESEARCH:
NHLBI Launches Body Cooling Treatment Study
for Pediatric Cardiac Arrest





Date: Tue, 19 Oct 2010 12:54:59 -0400
From: "NIH OLIB (NIH/OD)" <[log in to unmask]>
To: [log in to unmask]
Subject:  NHLBI Launches Body Cooling Treatment Study
for Pediatric Cardiac Arrest




U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News



National Heart, Lung, and Blood Institute (NHLBI)

http://www.nhlbi.nih.gov/



For Immediate Release: Tuesday, October 19, 2010




CONTACT:


NHLBI Office of Communications

301-496-4236

e-mail:

[log in to unmask]




NHLBI LAUNCHES BODY COOLING TREATMENT STUDY
FOR PEDIATRIC CARDIAC ARREST




NIH funds first large-scale, multicenter study to explore the use of 
temperature regulation in infants and children after cardiac arrest



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, 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, 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.



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.  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.



"Our goal is to minimize brain injury in infants and children who 
experience cardiac arrest and ultimately improve survival rates," said 
co-principal investigator J. Michael Dean, M.D., M.B.A., professor of 
pediatrics and chief of the Division of Pediatric Critical Care Medicine 
at the University of Utah School of Medicine, Salt Lake City.



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.



"These trials are addressing the question: What is the optimal temperature 
for an infant or child after cardiac arrest?" said co-principal 
investigator Frank W. Moler, M.D., M.S., a professor in the Department of 
Pediatrics and Communicable Diseases at the University of Michigan, Ann 
Arbor.  He added that in previous studies exploring therapeutic 
hypothermia, the comparison or control groups did not receive therapeutic 
normothermia to prevent fever.



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 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.





The 34 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.

-- Johns Hopkins Children's Center, Baltimore

-- 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




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 [log in to unmask] To interview Dr. Frank 
W. Moler, contact Margarita Bauza Wagerson, University of Michigan Health 
System at 734-764-2220 or [log in to unmask]  To interview Dr. J. Michael 
Dean, contact Phil Sahm, University of Utah Health Sciences Public Affairs 
Office at 801-581-2517 or [log in to unmask]



The NHLBI plans, conducts, and supports research related to the causes, 
prevention, diagnosis, and treatment of heart, blood vessel, lung, and 
blood diseases; and sleep disorders.  The Institute also administers 
national health education campaigns on women and heart disease, healthy 
weight for children, and other topics. NHLBI press releases and other 
materials are available online at



http://www.nhlbi.nih.gov



The National Institutes of Health (NIH) -- The Nation's Medical Research 
Agency -- includes 27 Institutes and Centers and is a component of the 
U.S. Department of Health and Human Services. It is the primary federal 
agency for conducting and supporting basic, clinical and translational 
medical research, and it investigates the causes, treatments, and cures 
for both common and rare diseases. For more information about NIH and its 
programs, visit




http://www.nih.gov




------------------



RESOURCES:




Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trials 
website:




http://www.thapca.org/



ClinicalTrials.gov THAPCA trials resources:

http://clinicaltrials.gov/ct2/show/NCT00880087?term=THAPCA&rank=1

and

http://clinicaltrials.gov/ct2/show/NCT00878644?term=THAPCA&rank=2



Cardiac Arrest:
<http://www.nhlbi.nih.gov/health/dci/Diseases/scda/scda_whatis.html



Children and Clinical Studies:
http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php



Collaborative Pediatric Critical Care Research Network (CPCCRN):

http://www.cpccrn.org/



Pediatric Emergency Care Applied Research Network (PECARN):

http://www.pecarn.org/




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The html version of this release contains an image at:

http://www.nhlbi.nih.gov/new/images/THAPCA.jpg




##




This NIH News Release is available online at:

http://www.nih.gov/news/health/oct2010/nhlbi-19.htm







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