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Subject:
From:
Meir Weiss <[log in to unmask]>
Reply To:
Cerebral Palsy List <[log in to unmask]>
Date:
Tue, 19 Oct 2010 14:00:18 -0400
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-----Original Message-----
From: NIH news releases and news items [mailto:[log in to unmask]] On
Behalf Of NIH OLIB (NIH/OD)
Sent: Tuesday, October 19, 2010 12:55 PM
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 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 <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/ 
------------------
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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