Archives: PECARN Studies
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.
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 began 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).
Every year ~500,000 infants present to EDs in the U.S. with fever as their presenting complaint. Six to 10% of these febrile infants will have invasive bacterial infections. Because there is no single reliable clinical or laboratory predictor of bacterial infections, clinicians depend of varying combinations of blood, urine, and cerebrospinal fluid (CSF) testing. These tests are invasive, often times inaccurate, and do not provide results quickly enough for ED disposition decisions.
The ultimate goal of this study protocol is to develop new, precise diagnostic tools that allow for less invasive, more accurate, and more timely evaluation and diagnosis of young febrile infants in the ED. This will be done by examining the patient’s immune response to bacterial and viral organisms, using RNA microarrays, and identify biosignatures that correctly classify the infants into bacterial, viral, co-infection, or uninfected groups. This study will prospectively gather clinical and RNA data on febrile infants <= 60 days of age who are being evaluated for bacterial infections in all PECARN EDs. Enrollment began in June 2016.
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 was published in Pediatric Emergency Care (2009).
Acute appendicitis is the most common surgical emergency in children. The current standard of treatment of acute appendicitis is appendectomy. With early recognition, increasing diagnostic accuracy and surgical advances, morbidity rates have dramatically lowered. However, surgery remains associated with pain, discomfort, risk of complications, and decreased quality of life. Because of the high incidence in childhood, appendicitis remains a substantial health care and societal burden.
Recently the paradigm for treating acute appendicitis has been challenged, with several randomized control trials (RCT) in adults showing that appendicitis may be safely treated with antibiotics alone. The goal of this multicenter, non-blinded intention-to-treat RCT is to compare the safety of non-operative management of uncomplicated appendicitis in children aged 5 to 18 years compared with urgent appendectomy. Patients will be randomized to either initial treatment with intravenous and oral antibiotics or urgent appendectomy, and followed for up to 4 years. We plan to enroll 1,036 participants in 8 PECARN sites over 3 years. This project is currently funded by a NIDDK planning grant. A U01 application was submitted in February 2018. If awarded, funding may begin as early as Fall 2018.
Medical errors are an important cause of morbidity and mortality, causing
the death of between 44,000 and 98,000 patients annually in the United
States. Little is known about medical errors in pediatric patients,
especially in the emergency department (ED) setting. This project, co-funded by the New York Department of Health, evaluated incident reports and medication records in 3 PECARN sites.
Specific Aims:
To classify and disseminate information from ongoing incident report monitoring, including actual and near-miss medication errors that occurred in the emergency department (i.e. qualitative surveillance).
To monitor medication error rates using systematic sampling and review of emergency department medical records (i.e. quantitative surveillance).
Over 3,000 medical records were reviewed and one year of incident reports were evaluated for this project.
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 has been published.
Traumatic brain injury (TBI) is the leading cause of morbidity from trauma in children, and one of the leading causes of death. Despite the frequency of TBI, its impact on the health of children, and decades of research, no effective treatment exists. For adults, however, there have been several recent phase II studies demonstrating the administration of progesterone to those with moderate-to-severe TBI is safe and may have substantial neuroprotective effects. The PECARN conducted a prospective observational yield study to: demonstrate the number of moderate-to-severely brain injured children presenting to PECARN hospitals, determine time of guardian arrival in order to determine appropriate consent methods, and evaluate fesibility of eligibility criteria. Data from this pilot will also allow us to determine how many clinical sites will be required for an interventional trial. Subject enrollment has concluded and a manuscript is in preparation.
This study addresses the critical need to improve pediatric sepsis outcomes by developing methods to accurately identify at-risk children presenting for emergency care. The project will capture electronic health record (EHR) data to create a multi-center registry with the ultimate goal of improving the detection and treatment of pediatric sepsis in the emergency department (ED) setting. To accomplish this, we will automate the determination of organ dysfunction in children with sepsis directly from structured and narrative data in an expanded multicenter EHR patient registry. That data will be used to derive and validate a prediction model of pediatric sepsis that predicts subsequent organ dysfunction within 48 hours using ED EHR data from the first 4 hours of care. Innovative deliverables from this project include the existence of a broad and rich EHR registry, an automated process of outcome determination, and a prediction model of risk of sepsis.