2/24/10
Areas of Current Research
(alphabetical order)
Application of Transcriptional Signatures for
Diagnosis of Febrile Infants within the PECARN Network:
The ultimate goal of this project is to incorporate a RNA-based diagnostic technology (called transcriptional signatures) to distinguish between bacterial and non-bacterial infections in otherwise well-appearing febrile infants who present to the EDs. The project aims to create a PECARN wide infrastructure for conducting translational genomic research and demonstrate feasibility of screening, consenting, collecting, and processing of small volumes of blood samples to abstract high quality RNA from febrile infants. After initially defining bacterial and non-bacterial biosignatures, we will conduct a limited validation of these diagnostic biosignatures on an independent group of febrile infants. Patient enrollment began in 2008 and continues through 2010.
Clinical Decision Rule to Identify
Children
with Intra-abdominal Injuries:
This is a prospective study of children with blunt torso trauma with a goal of identifying high-risk and low-risk indicators of intra-abdominal injury (IAI). The long term objective of the study is to derive, validate, disseminate and implement decision support tools to optimize the evaluation of children with blunt torso trauma, which will lead to reduced morbidity and mortality. The overall objective of this particular study is to develop a clinical decision rule for appropriate use of abdominal computerized tomography (CT) scanning in children with blunt torso trauma. We will create a decision rule that identifies those children in need of emergent CT scan and treatment, while reducing the use of abdominal CT scans in those children with minimal risk of IAI. The study was funded by the Centers for Disease Control and Prevention. Patient enrollment began in May, 2007 and concluded in January 2010. Data analysis is in progress.
Childhood Head Trauma: A Neuroimaging Decision Rule
This is a prospective study of children with minor-to-moderate blunt head trauma with a goal of identifying high-risk and low-risk indicators of traumatic brain injury (TBI). The goal is to derive the evidence on which to base appropriate use of head computerized tomography (CT) in children with acute head injury, which will hopefully reduce the number of unnecessary CT scans for children at very low risk for TBI. This will minimize the exposure of these children to the significant drawbacks related to CT (ionizing radiation, transport of children away from the direct observation of the emergency department, pharmacological sedation, and additional health care costs).
The study is co-funded by the Health Resources and Services Administration's (HRSA) Maternal and Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) Program and the Research Program. Data collection began in June, 2004 at all PECARN sites, and concluded in September, 2006. The network successfully enrolled 34,000 patients for the derivation of two clinical decision rules (one for children < 2 years and one for children > 2 years), and an additional 9,000 patients to validate the decision rules. Multiple abstracts from this study have been presented at national emergency medicine and pediatric meetings to date. Several manuscripts have been published including the main prediction rule manuscript which was published in Lancet (October 3, 2009). Data continue to be analyzed and there are many subanalyses and abstracts in progress.
Development of Research Partnerships with EMS Agencies and Descriptive Study of EMS Pediatric Population within PECARN:
The objective of this protocol is to study pediatric emergency medical services (EMS) within the PECARN network and establish the network’s capability to collect pre-hospital data. This is a descriptive study that will initiate data collection from EMS agencies. We plan to do this using methodology similar to the PECARN Core Data Project (PCDP). The project aims to demonstrate that pediatric EMS research is possible within PECARN and that data transmission from EMS agencies to the data center is feasible. This study will establish research relationships between PECARN sites and respective EMS agencies and gather data to understand the demographics and disease/injury patterns of the sample that is available to the PECARN network. The data collected will be invaluable in the future for generating hypotheses for pediatric EMS studies and providing preliminary data for grant applications. Similar to the PECARN Core Data Project mentioned above, this project will provide the groundwork for further meaningful pre-hospital research within the network.
Effectiveness of Oral Dexamethasone in Acute Bronchiolitis:
This study assesses the effectiveness and safety of the administration of oral dexamethasone for acute moderate to severe bronchiolitis in children seen in the ED, both with regard to the need for hospitalization (primary outcome), and severity and duration of disease (secondary outcomes). The study hypothesized that dexamethasone would be more effective than placebo in preventing hospital admission of infants with bronchiolitis.
This study was endorsed by the PECARN Steering Committee in January 2003 and was conducted at selected sites within PECARN for a three-year period (during Bronchiolitis seasons). The study was co-funded by the Health Resources and Services Administration's (HRSA) Maternal and Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) Program and the Research Program. Data collection began in January, 2004. The study concluded in Spring, 2006. We successfully enrolled 600 patients in this study, and we determined that there was no reduction in hospitalizations or improvement in respiratory scores associated with the administration of oral dexamethasone. Findings were published in the New England Journal of Medicine on July 26th, 2007. An abstract was presented at PAS and SAEM in 2008.
PECARN Core Data Project (PCDP):
This project is a cross-sectional study of all pediatric ED visits from all sites within the network. A database of electronic administrative data is compiled annually from 2002 to the present. This study has several aims:
- to identify the frequency and type of PECARN Emergency Department (ED) visits;
- to identify the availability of data elements from existing electronic databases and chart reviews at each HEDA;
- to identify the availability of clinical parameters collected during usual medical care of patients with selected diagnoses (asthma and long bone fractures);
- to measure the agreement between, and completeness of, data elements collected by electronic methods and chart review.
This study provides important epidemiological information regarding pediatric emergency department visits in the PECARN network. Data are collected annually from all hospital sites.
Pediatric Patient Safety in Emergency Departments
This study focuses on pediatric patient safety in the emergency departments (ED). The first phase involved surveys of pediatric ED staff to assess perceptions of safety. The manuscript for this phase has been published in Pediatrics (2009). The second phase of the study involves transmitting incident reports to the data center and classifying and quantifying ED events using a consensus process. A pilot study is also underway abstracting ED medical records and evaluating for medication errors. This project involves 3 PECARN sites.
Predicting Cervical Spine Injury (CSI) in Children:
Cervical spine injuries (CSI) are serious, but rare events in children. Immobilization of children with CSI in the out-of-hospital setting may be beneficial, but is poorly studied. In contrast, immobilization for transport of pediatric trauma patients without CSI is common and known to be associated with adverse effects. As a result, more than 99% of immobilized children have no CSI and are exposed to harm with no demonstrable benefit. The purpose of this study is to identify a set of variables that separate injured children with negligible risk of CSI from those at non-negligible risk for CSI. Specifically, project goals are to describe CSI and to identify factors associated with increased risk for CSI among a diverse pediatric blunt trauma population. This retrospective study concluded data collection at the end of 2007. Several abstracts have been presented in 2008 and 2009 at national meetings. The main manuscript is under review.
Referral and Utilization Patterns for Psychiatric
Related Visits to the Pediatric Emergency Department:
Pediatric psychiatric emergencies appear to have reached epidemic proportions over the past 10 years. ED visits related to mental health problems are known to be resource intensive, but data in this area has mainly occurred at individual sites. The aim of this retrospective chart review was to describe the patterns of referral and utilization of ED resources for children with a psychiatric related visit presenting to PECARN EDs. The findings of this study were presented at the Pediatric Ambulatory Society Annual Meeting in 2007. The main manuscript has been published in Pediatric Emergency Care (2009).
Therapeutic Hypothermia After
Cardiac Arrest in Children (THAPCA) Trials:
Cardiopulmonary arrest (when the heart stops beating) is a tragic event in children that is associated with high rates of death and long term disability. The study, entitled “Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA)”, will evaluate whether regulating the body temperature will improve the outcome for children after cardiac arrest. There is a separate study for children who arrest in the hospital (THAPCA-IH) and children who arrest out of the hospital (THAPCA-OH). The National Heart, Lung, and Blood Institute (NHLBI) is funding the first large scale, multi-center study to help determine the best treatment for children who are successfully resuscitated after a cardiac arrest.
The goal of these two trials is to determine if therapeutic hypothermia improves survival with good neurobehavioral outcome in children who have had a cardiac arrest. About 900 children will be enrolled in this study over 6 years at 30 clinical centers throughout the US and Canada. Enrollment in the THAPCA Trials is anticipated to begin in September, 2009.
The THAPCA Trials investigative team has worked collaboratively since 2002 bringing together two federally funded pediatric clinical research networks to study this problem. The two networks are the Pediatric Emergency Care Applied Research Network (PECARN), funded by the Emergency Medical Services for Children (EMSC) program and the NICHD Collaborative Pediatric Critical Care Resesarch Network (CPCCRN).
Use Of Lorazepam for the Treatment of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial of Lorazepam and Diazepam
Textbooks and expert opinion recommend both diazepam and lorazepam as initial therapy for children in status epilepticus (SE) and provide recommended doses that are commonly used. However, unlike diazepam, lorazepam is only FDA-approved for treatment for SE in patients over 18 years of age. Despite this fact, many experts support the use of lorazepam over diazepam in pediatric SE. Increased duration of action, increased effectiveness in terminating SE, and a lower incidence of respiratory depression have been cited as potential advantages of lorazepam over diazepam. However, data to support firm recommendations for one medication over another are lacking. Thus, either diazepam (FDA-approved) or lorazepam can be considered first-line agents for pediatric SE, and the physician's choice of agent depends on local practice patterns and individual treatment styles.
The purpose of this study is to determine the differences in efficacy and safety between these two commonly used benzodiazepines, as requested by the FDA under the Best Pharmaceuticals for Children Act, using the Exception from Informed Consent provided by the FDA.
