Great Lakes Atlantic Children’s Emergency Research (GLACiER) Node
GLACiER’s overarching goal is to improve the prevention and management of acute illnesses and injuries across the Emergency Medical Services for Children (EMSC) continuum of care by conducting community-informed, rigorous, multi-institutional research and disseminating research findings. To achieve this goal, GLACiER is organized around have five main objectives:
- Maintain our highly successful nodal infrastructure to foster high priority, high impact EMSC multi-centered research
- Improve health equity by engaging our communities to identify issues that affect EMSC in marginalized populations and inform all aspects of the research process
- Develop and retain a diverse research workforce
- Participate fully in PECARN-wide health record linkage projects
- Optimize dissemination of research findings through community and EMSC stakeholder engagement and robust knowledge translation activities
Institutions:
- Nationwide Children’s Hospital, Columbus, OH
- University of Pittsburgh, Children’s Hospital of Pittsburgh, Pittsburgh, PA
- Nemours Children’s Health Delaware Valley, Wilmington, DE
- Columbus Division of Fire
About The Pediatric Emergency Care Applied Research Network (PECARN)
The Pediatric Emergency Care Applied Research Network (PECARN) is the first federally funded multi-institutional network for research in pediatric emergency medicine in the United States.
The PECARN network consists of: Six of the Research Nodes contain three Hospital Emergency Department Affiliates (HEDAs) and one EMS Affiliate. PECARN sites represent academic, community, urban, general, and children's hospitals. The PECARN network Emergency Departments serve approximately 1.3 million acutely ill and injured children every year and the 9 EMS affiliates account for more than 113,000 pediatric runs annually.
Nodal Principal Investigator
Julie C. Leonard, MD, MPH
Abigail Wexner Research Institute at Nationwide Children's Hospital
700 Children's Drive
Columbus, OH, 43205
Phone: (614) 722-4385
Email: Julie.Leonard@NationwideChildrens.org
Nodal Administrator
Annie Truelove, MPH
Abigail Wexner Research Institute at Nationwide Children's Hospital
700 Children's Drive
Columbus, OH, 43205
Phone: (614) 355-5791
Email: Annie.Truelove@NationwideChildrens.org
HEDA Principal Investigators
Daniel M. Cohen, MD
Nationwide Children's Hospital
700 Children's Drive
Columbus, OH, 43205
Phone: (614) 355-3713
Email: Daniel.Cohen@NationwideChildrens.org
Robert Hickey, MD
UPMC Children’s Hospital of Pittsburgh
4401 Penn Ave.
Pittsburgh, PA, 15224
Phone: (412) 692-7692
Email: Robert.Hickey@chp.edu
Amy Thompson, MD
Nemours Children’s Health
1600 Rockland Road
Wilmington, DE,19803
Phone: (800) 416-4441
Email: Amythomp@nemours.org
EMS Scientific Advisor
Henry E. Wang, MD, MPH, MS
Ohio State University
376 West 10th Avenue
Columbus, OH, 43210
Phone: (614) 293-8305
Email: Henry.Wang@osumc.edu
Committees
Community Engagement and Dissemination
Sylvia Owusu-Ansah, MD, MPH
UPMC Children’s Hospital of Pittsburgh
Email: sylvia.owusuansah@chp.edu
Bashar Shihabuddin, MD, MS
Nationwide Children's Hospital
Email: Bashar.Shihabuddin@NationwideChildrens.org
Scientific Advisory Committee
David Brousseau, MD, MS
Nemours Children’s Health
Email: David.Brousseau@nemours.org
Pre-Hospital Advisory Committee
Henry E. Wang, MD, MPH, MS
Ohio State University
Email: Henry.Wang@osumc.edu
Workforce Development Committee
Rachel Stanley, MD, MHA
Nationwide Children's Hospital
Email: Rachel.Stanley@NationwideChilrens.org
Studies Actively Recruiting (For Providers)
- Exclusion of Pulmonary Embolism in Children without Radiation Exposure (BEEPER): A prospective, observational, cohort study of children ages 4 to 17 years old who have sufficiently high probability of pulmonary embolism (PE). The goal is to measure the diagnostic accuracy of a prediction rule for exclusion of PE (the PERC-Peds rule) and the D-dimer (a lab test used for diagnostic purposes). No study has been performed to prospectively record the presenting complaints, signs, symptoms and comorbidities of children who raised the suspicion of pulmonary embolism (PE) in children. Clinicians must extrapolate what is known about PE in adults to children potentially delaying diagnosis and/or causing unnecessary radiologic testing.
- A randomized controlled trial of abdominal ultrasound (FAST) in children with blunt abdominal trauma: The objective of this prospective randomized controlled trial is to determine whether the use of a focused assessment with sonography in trauma (FAST) impacts care in hemodynamically stable children with blunt chest or abdominal trauma
- Hyperhydration to Improve Kidney Outcomes in Children with Shiga Toxin-Producing E. Coli (HIKO STEC): This planning study will allow us to finalize RCT design, outcome measures, eligibility criteria, intervention and control arms, sample size, analysis plan and the preparation of study related materials. The CDC estimates that in the U.S., each year, over 175,000 individuals are infected by Shiga toxin-producing Escherichia coli (STEC). A complication of STEC infections is the hemolytic uremic syndrome (HUS). Preliminary data indicates that early volume expansion prior to the development of HUS can mitigate the complications of HUS.
- Pragmatic Pediatric Trial of Balanced Versus Normal Saline (NS) Fluid in Sepsis (PRoMPT BOLUS): In this pragmatic randomized comparative effectiveness trial that will enroll 8,930 children with suspected septic shock across PECARN hospitals, and will test the hypothesis that resuscitation with lactated Ringer’s (LR) improves hospital mortality, reduces kidney injury, and lowers length of stay compared to resuscitation with normal saline (NS). Sepsis is a leading cause of morbidity and mortality in children, for which crystalloid fluid resuscitation is a critical treatment. Although increasing data supports better efficacy and safety for LR than 0.9% NS, most children are resuscitated with NS and definitive data for the best fluid selection are lacking.
- Implementation of Evidence Based Care for the Acute Treatment of Sickle Cell Disease Pain (Sickle Cell Improvement: Enhancing Care in the ED)(SCIENCE): A mixed methods planning study (observational and qualitative) that aims to build the foundation for a future hybrid effectiveness-implementation trial. Guideline-based care, for children with Sickle Cell Disease (SCD), to prevent painful vaso-oclusive crisis (VOC) and provide treatment in a timely manner is infrequently followed, resulting in more frequent, prolonged pain and higher rates of Emergency Department visits and hospitalizations.
- Headache Assessment for Children with Emergent Intracranial Abnormalities Study (HEADACHE): The goal of the current study is to generate the definitive evidence that will allow clinicians to identify the risks of emergent brain abnormalities in otherwise healthy children presenting to EDs with headaches. The primary aim of our current study is to derive and internally validate a decision tool that stratifies the risk for children presenting to EDs with headaches.
- Pediatric Prehospital Airway Trial (PEDIPART): This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. EMS agencies from 10 sites across the country will participate in the trial. The study interventions are strategies of prehospital airway management: [BVM-only], [BVM followed by SGA] and [BVM followed by ETI]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: [BVM-only] or [BVM followed by SGA]. The [Winner of Stage I] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between [BVM followed by ETI] vs. [Winner of Stage I].
- Pediatric Dose Optimization for Seizures in EMS (PEDIDOSE): This study is a Phase 3, multi-center, stepped wedge trial of midazolam dosing for seizures in pediatric patients in the Emergency Medical Services (EMS) setting. It randomizes the timing of each of the participating EMS agencies at 20 different sites to switch from conventional, weight-based dosing to standardized, age-based dosing, so that every EMS agency switches from conventional to standardized dosing over a 4-year enrollment period in this 5-year study. Federal exception from informed consent (EFIC) procedures will be used for enrollment.
- Sickle Cell Treatment with Arginine Therapy Trial (STArT): The trial is designed as a double-blind, placebo controlled, randomized, phase 3, multi-center trial of IV arginine therapy in children with SCD and VOE to further knowledge on efficacy and safety of this orphan drug. The exploratory objective is to more fully characterize the arginine metabolome in children with SCD during VOE, and evaluate the effects of arginine therapy on global arginine bioavailability and mitochondrial function together with important clinical outcomes (time to VOE resolution, pain scores, total parenteral opioid use, Patient-Reported Outcomes (PROs), and hospital length of stay) in children with SCD and VOE.
Studies Actively Recruiting (For Patients)
- Exclusion of Pulmonary Embolism in Children without Radiation Exposure (BEEPER): The goal of this study is to provide evidence-based guidance to providers on the identification of blood clots in the lungs (also known as pulmonary embolisms) in children to promote timely diagnosis and treatment, while avoiding unnecessary radiation testing.
- A randomized controlled trial of abdominal ultrasound (FAST) in children with blunt abdominal trauma: The goal of this study is to determine how a bedside ultrasound performed by emergency medicine providers can help the care of injured children.
- Hyperhydration to Improve Kidney Outcomes in Children with Shiga Toxin-Producing E. Coli (HIKO STEC): The goal of this study is to determine the best method to prevent the complications from infections caused by bacteria (E.Coli) that cause diarrhea illness that could affect kidney function.
- Pragmatic Pediatric Trial of Balanced Versus Normal Saline (NS) Fluid in Sepsis (PRoMPT BOLUS): The goal of this study is to determine the optimal type of fluid to administer to critically ill children with signs of severe infection
- Implementation of Evidence Based Care for the Acute Treatment of Sickle Cell Disease Pain (Sickle Cell Improvement: Enhancing Care in the ED) (SCIENCE): The goal of this study is to ensure the optimal emergency department treatment of patients with sickle cell disease experiencing pain crises.
- Headache Assessment for Children with Emergent Intracranial Abnormalities Study (HEADACHE): The goal of this study is to help doctors do a better job deciding which children with headaches need head CT (“CAT scans”, “computed tomography”) or MRI scans as part of their emergency department care. It is important for doctors to know when to get a head CT or MRI and when it is not needed.
- Pediatric Prehospital Airway Trial (PEDIPART): The goal of this study is to compare three kinds of airway management techniques used by EMS to care for children experiencing a respiratory emergency:
- Bag-valve-mask ventilation; paramedics place a tight-fitting mask on top of the face and squeeze oxygen in through the mouth and nose and into the lungs.
- Endotracheal intubation; paramedics place a plastic tube down the throat through the voice box and squeeze oxygen into the windpipe and lungs.
- Supraglottic airways (i-gel, laryngeal tube or laryngeal mask airway); paramedics place a special tube in the mouth and down the throat above the voice box and squeeze oxygen towards the windpipe and lungs.
- Pediatric Dose Optimization for Seizures in EMS (PEDIDOSE): The goal of this study is to evaluate the way paramedics treat seizures with midazolam by determining the dose either based on the child’s age or by calculating it based on estimated weight.
- Sickle Cell Treatment with Arginine Therapy Trial (STArT): This study is being done to find out if IV arginine, given with pain medicine, will shorten how long the pain lasts. We believe adding IV arginine may help with the pain than just pain medication alone. Arginine given by IV has not been approved by the Food and Drug Administration (FDA) to treat sickle cell pain. Studies have shown that arginine IV in the arm is safe. Unfortunately, we still do not know if it will help with pain episodes.
This project is supported in part by the Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (MCHB), Emergency Medical Services for Children (EMSC) Network Development Demonstration Program under the following cooperative agreement numbers: U03MC00008, U03MC28844, U03MC22684, U03MC00007, U03MC00001, U03MC33154, U03MC33156, U03MC33155. This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government.