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  New Study Proposals

Pediatric Emergency Research Networks (PERN) is a conglomerate of regional & national research networks.  New study proposals that answer important questions about pediatric emergencies on an international and intercontinental level are welcome, and the strength of the networks is how PERN can be successful in moving the science forward.

New proposals are typically evaluated by one of the regional & national networks before being pushed to the Executive Committee of PERN.  Each of those networks has one of more liaisons that can help you evaluate your study proposal and champion it at the next PERN meetings.

To contact your corresponding network, please click here to navigate to the Aboud Us Page where we connect you to the individual networks.


Ongoing Projects Feed

ESETT: Established Status Epilepticus Treatment Trial

Link for more info: https://nett.umich.edu/clinical-trials/esett


Primary aims and objectives:   Determine the most effective therapy for SE that fails to respond to benzodiazepines: fos-phenytoin, valproate, or levetiracetam. Primary outcome is clinical cessation of status epilepticus, determined by the absence of clinically apparent seizures and improving responsiveness, at 60 minutes after the start of study drug infusion, without the use of additional anti-seizure medication.

Secondary aims and objectives Occurrence of life threatening hypotension or cardiac arrhythmia, time to termination of seizures, intubation, admission to ICU, seizure recurrenece, length of stay in ICU and hospital, mortality

Arginine Feasibility Study


Primary aims and objectives:   Establish a protocol steering committee with expertise in Sickle Cell Disease (SCD) clinical trials, create a clinical network of sites with a strong track record of successful participation in multi-center trials, create an ED-based pain protocol, develop a data coordinating plan, identify safety and clinical endpoints and a completed protocol for a phase III clinical trial of L-arginine for the treatment of vaso-occlusive pain in children with SCD to be submitted for NIH funding

Secondary aims and objectives This study is creating a standardized ED-based pain therapy protocol based on NIH guidelines that will be utilized in the future phase III trial, collecting feasibility data on volume, time of visit and admission rates from high-volume PECARN and non-PECARN sites on all potentially eligible patients with SCD and collecting demographic and clinical data through a 20 patient chart review at each participating site.

ED STARS: Emergency Department Screen for Teens at Risk for Suicide


Primary aims and objectives:   Develop and test a brief, personalized, computer-based suicide risk screening tool for teenagers. In the projects first study, over 6,000 youth will be screened, and researchers will follow up on a subsample of 12-17 year-olds who score high on suicide risk factors as well as those who score low. Their experiences over a 6-month period will be used to develop a computerized adaptive screen (CAS) for predicting suicide attempts that adjusts its line of questioning depending on responses to previous questions. The researchers will then compare the sensitivity, specificity, and predictive value of the CAS with the Ask Suicide-Screening Questions (ASQ), a standardized ED youth suicide prevention screening tool. A second study will validate the CAS and associated risk stratification algorithm, determining the measures ability to predict suicide attempts in a new sample of over 2,000 youth. The potential benefit of including a behavioral test of suicidal thoughts, the Implicit Association Test (IAT), as part of the screening process will also be evaluated.

PECARN Core Data Project


Primary aims and objectives:   "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 provides important epidemiological information regarding pediatric emergency department visits in the PECARN network. Data are collected annually from all hospital sites. The public use dataset is available by request.

Improving the Quality of Pediatric Emergency Care Using an Electronic Medical Record Registry and Clinician Feedback


Primary aims and objectives:   " We will capture electronic health record (EHR) data to implement and report pediatric emergency medicine quality performance measures with the goal of providing decision-makers with a tool to track, report, and improve the quality of emergency care for children, within and across sites of care. This project has the following three specific aims: 1. Develop an emergency care visit registry for pediatric patients. We will merge electronic health record clinical data from different hospital EDs with different EHR data sources. This new registry will serve as the foundation for current and future studies, obviating the need for resource-intensive chart review. 2. Use this registry to collect stakeholder-prioritized emergency care performance measures for important pediatric medical and trauma conditions at the level of both the ED and individual clinician. Using performance measure data, we will develop achievable benchmarks of care to promote performance improvement. 3. Use this registry to report performance to individual ED clinicians. We will test the hypothesis that providing regular performance measure feedback will improve performance and decrease variation among ED clinicians using a staggered time-series study. "

RNA Biosignatures: A Paradigm Change for the Management of Young Febrile Infants


Primary aims and objectives:   "The study investigators have identified novel and distinct RNA expression patterns (RNA biosignatures) in febrile infants 60 days of age. This proof-of-concept work has demonstrated well-defined RNA biosignatures in infants with bacterial and non-bacterial infections. Febrile infants with bacterial infections have distinct RNA gene expression patterns characterized by over-expression of inflammatory genes, while interferon genes are consistently over-expressed in febrile infants without bacterial infections. This previous work has identified 66 classifier genes that discriminate febrile infants with bacterial infections with 87% accuracy, suggesting a potentially more accurate reference than microbiologic cultures. The long-term objective of this currrent research protocol is to investigate whole genome RNA expression profiles to define RNA biosignatures that allow precise diagnosis of isolated bacterial infections, isolated viral infections and bacterial-viral co-infections in febrile infants 60 days of age. Addressing the optimal evaluation and management of the febrile infant will assure that this vulnerable population of children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability. Specific Aim 1. Define the RNA biosignatures in febrile infants 60 days of age with isolated bacterial infections, isolated viral infections, and viral-bacterial co-infection. Specific Aim 2. Demonstrate the stability of the RNA biosignatures to distinguish febrile infants 60 days of age with isolated bacterial infections, isolated viral infections, and viral-bacterial co-infections over a 24 72 hour time period. Specific Aim 3. Validate the RNA biosignatures on a novel, PCR-based platform that has a rapid (2 4 hours) turnaround time. Specific Aim 4. Validate a previously derived decision rule for prediction of bacterial infection that includes procalcitonin measurement.

Understanding Discharge Instruction for Children and Caregivers in the Transition from Pediatric Emergency Care


Primary aims and objectives:   The overall goal of this feasibility work is to develop and evaluate a model for engaging parents in the design and implementation of theory based discharge communication strategies

Alberta E. Coli outbreak: A missed opportunity for intervention


Primary aims and objectives:   1) Quantify the time interval between the initial presentation with symptoms of E. coli 0157 infection and the identification of infection via stool culture. 2) Quantify the duration of symptoms prior to development of HUS. 3) Determine the number of health care provider visits between the onset of symptoms until A) positive culture and B) development of HUS. 4) Determine the proportion of children with E. coli O157:H7 infection that had blood tests performed, how many of them were repeated and how physicians managed laboratory abnormalities. 5) To determine the proportion of children given antibiotics during the course of their infection.

Alberta Provincial Pediatric EnTeric Infection TEam (APPETITE): Epidemiology, Emerging Organisms, and Economics


Primary aims and objectives:   We propose a multidisciplinary, province-wide program which will employ sophisticated techniques to collect and analyze novel data, placing us as a leader in the field of enteric diseases. Our innovative prospective approach will overcome both the bias and barriers inherent to traditional surveillance systems. We will create and combine a comprehensive enteric disease clinical data repository with cutting edge microbiologic testing and a focused economic analysis.

Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis


Primary aims and objectives:   The primary objective of this large multicentre randomized clinical trial is to quantify the reduction in disease severity from the administration of a probiotic agent, as compared with placebo, in 1006 children aged 3 to 48 months presenting to the emergency department with less than 48 hours of gastroenteritis symptoms.

Developing an Internet-based program for anxious youth who visit the emergency department for mental health care: A strategy to increase access to care


Primary aims and objectives:   Those adolescents who meet study inclusion criteria are being allocated to either 8 weeks of Internet-based CBT with telephone and email support, or a control (minimal intervention) group with access to a static webpage listing general anxiety resources.

A Trial to Determine Whether Septic Shock Reversal is Quicker in Pediatric Patients Randomized to an Early Goal Directed Fluid-Sparing Strategy vs. Usual Care (SQUEEZE Trial)


Primary aims and objectives:   The overall objective of our research programme is therefore to evaluate whether use of a more conservative fluid sparing strategy that involves the earlier initiation and escalation of vasoactive medications to achieve ACCM goal directed targets, results in improved clinical outcomes for children experiencing septic shock.

Short-Course Antimicrobial Therapy for Paediatric Respiratory Infections (SAFER)


Primary aims and objectives:   Our primary objective is to determine whether in previously healthy children with uncomplicated CAP a 5-day course of oral high-dose amoxicillin will lead to non-inferior rates of early clinical cure in comparison with the standard 10-day course of oral amoxicillin.

How safe are our pediatric emergency departments? A national prospective cohort study


Primary aims and objectives:   The objective of our proposed multi-centre, prospective cohort study is to generate an estimate of the risk and type of AEs, as well as their preventability and severity, for all children seen in pediatric EDs across Canada.

Magnesium Nebulization Utilization in Management of Pediatric Asthma - MagNUM PA Trial


Primary aims and objectives:   To examine the utilization of intravenous magnesium in Canadian pediatric Emergency Departments (EDs) in children requiring hospitalization for acute asthma and association of administration of frequent albuterol/ipratropium and timely corticosteroids with hospitalization.

EcLiPSE: Emergency treatement with Levetiracetam or Phenytoin in Status Epilepticus

Link for more info: http://www.eclipse-study.org.uk


Primary aims and objectives:   Determine whether levetiracetam or phenytoin is the most effective second line anti-epileptic therapy for CSE. Primary endpoint is time to cessation of all visible signs of convulsive seizure activity

Secondary aims and objectives "1. Need for further anticonvulsants to manage the seizure after the initial agent 2. Need for RSI due to ongoing CSE 3. Need to be admitted to critical care 4. Serious adverse reactions including death, airway complications, cardiovascular instability, and purple glove syndrome"

Mortality in Pediatric Emergency Departments

Link for more info: https://sites.google.com/site/repemnetwork/current


Primary aims and objectives:   "Objective: to create an European registry of mortality in the Pediatric EmergencyDepartment. Specificresearchquestions: Whicharethemaincausesofdeathofchildrenwhodiedintheemergencyroom? Which are the characteristics of deceased patients? How is the management of thesecasesinthe prehospitalaryandhospitalarysettings?"

Pediatric Cardiac Arrest European Registry in Emergency Services (e-PEDCARE)

Link for more info: https://sites.google.com/site/repemnetwork/current


Primary aims and objectives:   Understand the socio-demographic and health characteristics related to cardiac arrest; its treatment; survival rates; and the long-term neurological status for children who suffer cardiac arrest at a paediatric emergency room or who come to an ER after suffering cardiac arrest.

Secondary aims and objectives Understand the factors associated with the prognosis and long-term neurological status

Evaluation of the variability in the management of minor head trauma in children in Europe

Link for more info: https://sites.google.com/site/repemnetwork/current


Primary aims and objectives:   To investigate the variation of management of apparently minor head trauma (GCS 1415) in children visited at one of the ED that will be involved in the project. We will consider the PECARN clinical prediction rules as a reference standard to assess any variation of management.

Secondary aims and objectives To evaluate the rate of imaging ordered, number of patients admitted or observed to understand whether any difference could be attributed to the different management of the patients or differences existing among EDs

PERN Pneumonia Study


Primary aims and objectives:   To characterize care patterns across the world for children with diagnoses of pneumonia









Department of Emergency Medicine
University of California, Davis Medical Center
2315 Stockton Blvd. PSSB Suite 2100
Sacramento,  CA , USA
95817

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