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October 17, 2011

White children more likely than minorities to receive CT scans following minor head trauma

CT scans may be overused in white children with low risk head injuries, which could result in increased radiation exposure and health care costs

BOSTON – African-American and Hispanic children are less likely to receive a cranial computed tomography (CT) scan in an emergency department following minor head trauma than white children, according to University of Michigan research presented Oct. 14 at the American Academy of Pediatrics National Conference and Exhibition in Boston.

Description: http://www.uofmhealth.org/um_core/ccurl/864/87/CT%20control%20room.JPGWhile racial disparities in adult health care are well documented, less is known about the variations in pediatric, and specifically, Emergency Department care. Appropriate CT scan use can ensure optimal diagnosis. However, as CT scans emit "appreciable radiation," potentially increasing cancer risk, their overuse can be harmful and expensive.
In the study, "Cranial CT Use for Minor Head Trauma in Children is Associated with Race/Ethnicity," researchers at the University of Michigan and other institutions including University of California-Davis, reviewed existing data on children seeking care at one of 25 Pediatric Emergency Care Applied Research Network (www.pecarn.org) trauma centers. The study looked at CT use following a head injury, based on the child's potential for traumatic brain injury.

Of the 42,412 children enrolled in the main study, all of whom were evaluated for head trauma, 39,717 (94 percent) had a documented race/ethnicity of Hispanic, African-American or white. 

Of these, 13, 793 children (35 percent) were imaged with a CT. While there was no significant difference by race/ethnicity in the likelihood that a child deemed at higher risk for a traumatic brain injury would receive a CT scan, white children at the lowest risk were significantly more likely to receive a CT scan.

"Our study demonstrates that among children with minor head trauma, but at low risk for clinically important brain injury, white children received cranial CT scans more frequently than black or Hispanic children," says Alexander Rogers, M.D., F.A.A.P., assistant professor of emergency medicine at the University of Michigan Health System. "In this low-risk population, higher rates of cranial CT may represent overuse in white children, leading to increased radiation exposure and health care costs.""The cause of this disparity is likely multi-factorial, but this study highlights the importance of strong, evidence-based guidelines to assure equal and optimal care," Rogers adds.

The abstract is available at:  http://aap.confex.com/aap/2011/webprogrampress/Paper13084.html

The University of Michigan C.S. Mott Children’s Hospital (www.mottchildren.org) is consistently ranked as one of the best hospitals in the country. It was nationally ranked in all ten pediatric specialties in the U.S. News Media Group’s 2011 edition of "America’s Best Children’s Hospitals" including third in the country for heart and heart surgery. In November, the hospital moves to a new 1.1 million square feet, $754 million state-of-the-art facility that will be home to cutting-edge specialty services for newborns, children and women.
 
The American Academy of Pediatrics is an organization of 60,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and wellbeing of infants, children, adolescents and young adults. For more information, visit http://www.aap.org. By the American Academy of Pediatrics


August 15, 2011

The University of Michigan is one of six Recipients of a New PECARN Award

The Health Resources and Services Administration (HRSA), Emergency Medical Services for Children (EMSC) Program announced on August 15, 2011, that it will fund six Research Node Centers (RNC) through the competitive funding mechanism known as the Network Development Demonstration Project (NDDP). These six RNCs form the Pediatric Emergency Care Applied Research Network (PECARN), the first federally funded, multi-institutional network for research in pediatric emergency medicine. PECARN has been in existence since 2001 and has conducted high priority, collaborative research in pediatric emergency medicine.

The six awardees are:

Great Lakes Emergency Medical Services for Children Research Network (GLEMSCRN). Led by Principal Investigator Rachel Stanley, MD, MHSA, of University of Michigan, this Node will include the following HEDAs: University of Michigan (Alex Rogers, MD, principal investigator); Children's Hospital of Michigan (Prashant Mahajan, MD, MBA, MPH, principal investigator); and Nationwide Children's Hospital (Bema Bonsu, MD, principal investigator).

Hospitals of the Midwest Emergency Research Node (HOMERUN). Led by Principal Investigator Rich Ruddy, MD, of Cincinnati Children's Hospital Medical Center, this Node will include the following HEDAs: Cincinnati Children's Hospital Medical Center (Lynne Babcock Cimpello, MD, MPH, principal investigator); Washington University School of Medicine (David Jaffe, MD, principal investigator); and Children's Hospital of Wisconsin-Medical College of Wisconsin (David Brousseau, MD, principal investigator).

Pediatric Emergency Medicine Northeast, West and South (PEM-NEWS). Led by Principal Investigator Peter Dayan, MD, MSc, of Children's Hospital of New York, this Node will include the following HEDAs: Children's Hospital of New York (Maria Kwok, MD, MPH, principal investigator); Texas Children's Hospital (Charles Macias, MD, MPH, principal investigator); and Children's Hospital Colorado (Lalit Bajaj, MD, MPH, principal investigator).

Pediatric Research in Injuries and Medical Emergencies (PRIME). Led by Principal Investigator Nate Kuppermann, MD, MPH, of University of California-Davis, this Node will include the following HEDAs: University of California-Davis (Leah Tzimenatos, MD, principal investigator); Children's Hospital of Philadelphia (Libby Alpern, MD, MSCE, principal investigator); and Primary Children's University of Utah (Doug Nelson, MD, principal investigator).

Pittsburg, Rhode Island, Delaware Network (PRIDENET). Led by Principal Investigator Bob Hickey, MD, of Children's Hospital of Pittsburg, this Node will include the following HEDAs: Children's Hospital of Pittsburg (Bob Hickey, MD, principal investigator); Hasboro Children's Hospital (Tom Chun, MD, principal investigator); and AI Dupont Hospital for Children (Jonathan Bennett, MD, principal investigator).

Washington, Boston, Chicago Applied Research Node (WBCARN). Led by Principal Investigator Jim Chamberlain, MD, of Children's National Medical Center, this Node will include the following HEDAs: Children's National Medical Center (Kathy Brown, MD, principal investigator); Children's Memorial Hospital (Elizabeth Powell, MD, MPH, principal investigator); and Children's Hospital of Boston (Lise Nigrovic, MD, MPH, principal investigator).

For more information about PECARN, visit http://www.pecarn.org/.

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Winter 2011

Investigators from the Great Lakes Node Leading Three PECARN Studies

Investigators from the Great Lakes Node (GLEMSCRN) of PECARN are leading three PECARN studies.  Rachel Stanley, M.D., M.H.S.A., GLEMSCRN Nodal Principal Investigator, Frank Moler, M.D., M.S., University of Michigan and Prashant Mahajan, M.D., M.P.H., M.B.A., HEDA Principal Investigator, Children’s Hospital of Michigan/Wayne State University, have received funding to lead three important studies. 

Study on body cooling study for pediatric cardiac arrest

Frank Moler, M.D., M.S., University of Michigan, and J. Michael Dean, M.D., M.B.A., University of Utah are leading 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.

Dr. Moler, scientific principal investigator, is a professor in the Department of Pediatrics and Communicable Diseases at the University of Michigan and a co-investigator in Great Lakes Node of PECARN.   J. Michael Dean, M.D., M.B.A., principal investigator of the study's data coordinating center, is a professor of pediatrics, chief of the Division of Pediatric Critical Care Medicine at the University of Utah School of Medicine, and the PI for the PECARN Central Data Management Coordinating Center (CDMCC).

Also known as the Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trials, the work is being conducted over a six-year period in 34 clinical centers in the United States and Canada with funding from the National Heart, Lung, and Blood Institute (NHLBI).

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.

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 survival rates.

During body cooling treatment, 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.

 The THAPCA trials are being conducted in partnership between PECARN and the Collaborative Pediatric Critical Care Research Network, established in 2004 by the Eunice Kennedy Shriver  National Institute of Child Health and Human Development (NICHD). 

Study to evaluate use of RNA Biosignatures to determine cause of fever in infants

Drs. Prashant Mahajan, Children’s Hospital of Michigan,  Octavio Ramillo, Nationwide Children’s Hospital and Nathan Kuppermann, University of California at Davis, are leading a study investigating the use of RNA biosignatures to distinguish between bacterial and viral infections in young infants with fevers evaluated in emergency departments. This could lead to more rapid and accurate diagnoses and treatment for serious bacterial infections such as bacteremia and meningitis.  Prashant Mahajan, M.D., M.P.H., M.B.A., is the PECARN HEDA PI for Children’s Hospital of Michigan/Wayne State University, Octavio Ramilo, MD, is chief of Infectious Diseases at Nationwide Children's Hospital and Nathan Kuppermann, M.D., M.P.H., is the nodal PI for the ACORN node of PECARN. 

Fever is the third leading cause of emergency department (ED) visits and accounts for 15% of all ED visits in infants 60 days of age and younger. Despite the frequency of fever in young infants presenting to EDs, and the importance of this topic to emergency medical services for children (EMSC), to date there is no single or a combination of clinical parameters and laboratory tests that can uniformly distinguish infants with serious bacterial infections from those with uncomplicated and self limiting viral or non-bacterial infections. Indeed, there have been no new technologies that have been routinely and successfully applied in the evaluation of these infants and novel, highly accurate tests are clearly needed.

 In the current era, however, there are novel methods that may potentially offer higher fidelity in distinguishing among febrile infants with different types of infections. The most exciting advance pertains to a fundamental shift in the way we approach the diagnosis of different infectious diseases. Instead of attempting to detect the pathogens directly, it has become possible to detect the presence of infection by assessing the specific host response to different pathogens.

Advances in genomic sequencing and techniques for conducting high through-put deoxynucleic acid (DNA) and ribonucleic acid (RNA) analysis have led to a better understanding of the host-pathogen response during infections. Thus, a novel approach to distinguish febrile infants young infected with bacterial pathogens from those infected with non-bacterial pathogens is to examine the host response to infection. Recent data indicate that different pathogens induce distinct transcriptional “biosignatures” in the RNA of blood leukocytes that can be reliably measured by microarray analysis.

The multi-site study is being conducted at some 20 children's hospitals, most within the Pediatric Emergency Care Applied Research Network (PECARN) network.

Funding for the project is provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Study to look at progesterone’s effect on children with traumatic brain injuries

Rachel Stanley, M.D., M.H.S.A., GLEMSCRN Nodal PI, has received a two-year grant to plan a randomized controlled study of progesterone to treat traumatic brain injuries in children.  Stanley will lead the planning efforts for a future large safety and efficacy trial of progesterone for pediatric traumatic brain injury.  Dr. Nathan Kuppermann, M.D., M.P.H., ACORN Nodal PI, will serve as the co-principal investigator on the study.

Traumatic brain injury (TBI) is the leading cause of death from trauma, and of death in children. Despite the frequency of TBI (more than 1 million annual cases nationally), its impact on the health of children, and decades of research on the topic, no effective treatment exists for children with TBI.   While previous single-center human studies have shown promising results in adults, and a multi-center study on the use of progesterone for TBI in adults is currently underway in the Neurological Emergencies Treatment Trials Network, no previous studies have included children.   

Progesterone is a potent neurosteroid that is naturally synthesized in the central nervous system. Animal studies have shown that early administration of progesterone after experimental TBI reduces cerebral edema, neuronal loss, and limits behavioral deficits in laboratory animals. Progesterone is an ideal candidate for treatment of TBI for several reasons. Progesterone enters the brain rapidly and reaches equilibrium with the plasma within an hour of administration. Progesterone also has a long history of safe use in men and women.

The planning project will establish the inclusion/exclusion criteria and outcomes for a future trial and will include an observational study at 15 PECARN sites to determine how many sites are necessary for a future interventional trial, as well as determining the timing of arrival of a legal guardian for consent purposes. The end product of this planning project will be a protocol for a large safety and efficacy trial of progesterone for pediatric TBI. This project is currently under way with an end date of the fall of 2012. 
Funding for this project is provided by the Health Resources and Services Administration, Maternal and Child Health Bureau. The grant is an Emergency Medical Services for Children (EMSC) Targeted Issues Grant. 

Investigators from the Great Lakes Node Leading Three PECARN Studies

Investigators from the Great Lakes Node (GLEMSCRN) of PECARN are leading three PECARN studies.  Rachel Stanley, M.D., M.H.S.A., GLEMSCRN Nodal Principal Investigator, Frank Moler, M.D., M.S., University of Michigan and Prashant Mahajan, M.D., M.P.H., M.B.A., HEDA Principal Investigator, Children’s Hospital of Michigan/Wayne State University, have received funding to lead three important studies. 

Study on body cooling study for pediatric cardiac arrest

Frank Moler, M.D., M.S., University of Michigan, and J. Michael Dean, M.D., M.B.A., University of Utah are leading 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.

Dr. Moler, scientific principal investigator, is a professor in the Department of Pediatrics and Communicable Diseases at the University of Michigan and a co-investigator in Great Lakes Node of PECARN.   J. Michael Dean, M.D., M.B.A., principal investigator of the study's data coordinating center, is a professor of pediatrics, chief of the Division of Pediatric Critical Care Medicine at the University of Utah School of Medicine, and the PI for the PECARN Central Data Management Coordinating Center (CDMCC).

Also known as the Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trials, the work is being conducted over a six-year period in 34 clinical centers in the United States and Canada with funding from the National Heart, Lung, and Blood Institute (NHLBI).

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.

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 survival rates.

During body cooling treatment, 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.

 The THAPCA trials are being conducted in partnership between PECARN and the Collaborative Pediatric Critical Care Research Network, established in 2004 by the Eunice Kennedy Shriver  National Institute of Child Health and Human Development (NICHD). 

Study to evaluate use of RNA Biosignatures to determine cause of fever in infants

Drs. Prashant Mahajan, Children’s Hospital of Michigan,  Octavio Ramillo, Nationwide Children’s Hospital and Nathan Kuppermann, University of California at Davis, are leading a study investigating the use of RNA biosignatures to distinguish between bacterial and viral infections in young infants with fevers evaluated in emergency departments. This could lead to more rapid and accurate diagnoses and treatment for serious bacterial infections such as bacteremia and meningitis.  Prashant Mahajan, M.D., M.P.H., M.B.A., is the PECARN HEDA PI for Children’s Hospital of Michigan/Wayne State University, Octavio Ramilo, MD, is chief of Infectious Diseases at Nationwide Children's Hospital and Nathan Kuppermann, M.D., M.P.H., is the nodal PI for the ACORN node of PECARN. 

Fever is the third leading cause of emergency department (ED) visits and accounts for 15% of all ED visits in infants 60 days of age and younger. Despite the frequency of fever in young infants presenting to EDs, and the importance of this topic to emergency medical services for children (EMSC), to date there is no single or a combination of clinical parameters and laboratory tests that can uniformly distinguish infants with serious bacterial infections from those with uncomplicated and self limiting viral or non-bacterial infections. Indeed, there have been no new technologies that have been routinely and successfully applied in the evaluation of these infants and novel, highly accurate tests are clearly needed.

 In the current era, however, there are novel methods that may potentially offer higher fidelity in distinguishing among febrile infants with different types of infections. The most exciting advance pertains to a fundamental shift in the way we approach the diagnosis of different infectious diseases. Instead of attempting to detect the pathogens directly, it has become possible to detect the presence of infection by assessing the specific host response to different pathogens.

Advances in genomic sequencing and techniques for conducting high through-put deoxynucleic acid (DNA) and ribonucleic acid (RNA) analysis have led to a better understanding of the host-pathogen response during infections. Thus, a novel approach to distinguish febrile infants young infected with bacterial pathogens from those infected with non-bacterial pathogens is to examine the host response to infection. Recent data indicate that different pathogens induce distinct transcriptional “biosignatures” in the RNA of blood leukocytes that can be reliably measured by microarray analysis.

The multi-site study is being conducted at some 20 children's hospitals, most within the Pediatric Emergency Care Applied Research Network (PECARN) network.

Funding for the project is provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Study to look at progesterone’s effect on children with traumatic brain injuries

Rachel Stanley, M.D., M.H.S.A., GLEMSCRN Nodal PI, has received a two-year grant to plan a randomized controlled study of progesterone to treat traumatic brain injuries in children.  Stanley will lead the planning efforts for a future large safety and efficacy trial of progesterone for pediatric traumatic brain injury.  Dr. Nathan Kuppermann, M.D., M.P.H., ACORN Nodal PI, will serve as the co-principal investigator on the study.

Traumatic brain injury (TBI) is the leading cause of death from trauma, and of death in children. Despite the frequency of TBI (more than 1 million annual cases nationally), its impact on the health of children, and decades of research on the topic, no effective treatment exists for children with TBI.   While previous single-center human studies have shown promising results in adults, and a multi-center study on the use of progesterone for TBI in adults is currently underway in the Neurological Emergencies Treatment Trials Network, no previous studies have included children.   

Progesterone is a potent neurosteroid that is naturally synthesized in the central nervous system. Animal studies have shown that early administration of progesterone after experimental TBI reduces cerebral edema, neuronal loss, and limits behavioral deficits in laboratory animals. Progesterone is an ideal candidate for treatment of TBI for several reasons. Progesterone enters the brain rapidly and reaches equilibrium with the plasma within an hour of administration. Progesterone also has a long history of safe use in men and women.

The planning project will establish the inclusion/exclusion criteria and outcomes for a future trial and will include an observational study at 15 PECARN sites to determine how many sites are necessary for a future interventional trial, as well as determining the timing of arrival of a legal guardian for consent purposes. The end product of this planning project will be a protocol for a large safety and efficacy trial of progesterone for pediatric TBI. This project is currently under way with an end date of the fall of 2012. 
Funding for this project is provided by the Health Resources and Services Administration, Maternal and Child Health Bureau. The grant is an Emergency Medical Services for Children (EMSC) Targeted Issues Grant. 

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