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.
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 focused on pediatric patient safety in the emergency department (ED). The first phase involved surveys of pediatric ED staff to assess perceptions of safety. The manuscript for this phase was published in Pediatrics (2009). The second phase of the study involved transmitting incident reports to the data center and classifying and quantifying ED events using a consensus process. Analysis of over 3000 incidents reports was completed and various manuscripts discussing medication errors/events, radiology events, laboratory events, process variance events, and near-miss errors have been published. A newsletter summarizing findings from the medication error review has been distributed to share information on prevention of medication errors in the emergency departments that care for children.
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. The public use dataset is available on this website.
Children with sickle cell disease (SCD) are at risk for acute vasoocclusive crises, the most frequent of which are pain crises. The usual treatment for pain crises, intravenous (IV) fluids and pain medicine, has changed little over the past three decades. The purpose of this study was to determine the safety and efficacy of intravenous magnesium in shortening the duration of a pain crisis and to determine the health-related quality of life and short term outcomes of children treated with intravenous magnesium during an acute pain crisis. This was a multi-center, randomized, double-blind, placebo controlled trial. Patients were randomized to receive either the study drug or placebo every eight hours for a total of six doses, or until discharge, whichever occurred first. Patients were followed up by phone one week after discharge to assess rehospitalization rates, and returned to the sickle cell clinic for follow up within 3 months after discharge. Enrollment began in December 2010 and concluded Dec 2013. This project was co-funded by NICHD and NHLBI. Findings were published in Blood on July 31, 2015.
