Article Text

Protocol
Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol
  1. Anna L. Funk1,
  2. Todd A. Florin2,
  3. Stuart R. Dalziel3,4,
  4. Santiago Mintegi5,
  5. Marina I. Salvadori6,
  6. Daniel Joseph Tancredi7,
  7. Mark I. Neuman8,
  8. Daniel C. Payne9,
  9. Amy C. Plint10,11,
  10. Terry P. Klassen12,
  11. Richard Malley13,
  12. Lilliam Ambroggio14,
  13. Kelly Kim1,
  14. Nathan Kuppermann15,
  15. Stephen B. Freedman16
  1. 1Department of Pediatrics, Alberta Children's Hospital Research Institute, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
  2. 2Division of Emergency Medicine, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
  3. 3Departments of Surgery and Paediatrics: Child and Youth Health, The University of Auckland, Auckland, Auckland, New Zealand
  4. 4Children's Emergency Department, Starship Children's Health, Newmarket, Auckland, New Zealand
  5. 5Pediatric Emergency Department, Biocruces Bizkaia Health Research Institute, Hospital Universitario Cruces, Barakaldo, Spain
  6. 6Public Health Agency of Canada, Ottawa, Ontario, Canada
  7. 7Department of Pediatrics, University of California Davis, Davis, California, USA
  8. 8Division of Emergency Medicine, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA
  9. 9National Center for Emerging Zoonotic Infectious Diseases, Division of Foodborne Waterborne and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
  10. 10Department of Pediatrics and Emergency Medicine, University of Ottawa, Ottawa, Ontario, Canada
  11. 11Division of Emergency Medicine, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
  12. 12Children's Hospital Research Institute of Manitoba, Department of Pediatrics, University of Manitoba, Winnipeg, Manitoba, Canada
  13. 13Division of Infectious Disease, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA
  14. 14Sections of Emergency Medicine, Department of Pediatrics, Children's Hospital Colorado, University of Colorado, Denver, Colorado, USA
  15. 15Departments of Emergency Medicine and Pediatrics, University of California Davis School of Medicine, Sacramento, California, USA
  16. 16Pediatrics, Cumming School of Medicine, Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada
  1. Correspondence to Dr Stephen B. Freedman; stephen.freedman{at}albertahealthservices.ca

Abstract

Introduction Relatively limited data are available regarding paediatric COVID-19. Although most children appear to have mild or asymptomatic infections, infants and those with comorbidities are at increased risk of experiencing more severe illness and requiring hospitalisation due to COVID-19. The recent but uncommon association of SARS-CoV-2 infection with development of a multisystem inflammatory syndrome has heightened the importance of understanding paediatric SARS-CoV-2 infection.

Methods and analysis The Paediatric Emergency Research Network-COVID-19 cohort study is a rapid, global, prospective cohort study enrolling 12 500 children who are tested for acute SARS-CoV-2 infection. 47 emergency departments across 12 countries on four continents will participate. At enrolment, regardless of SARS-CoV-2 test results, all children will have the same information collected, including clinical, epidemiological, laboratory, imaging and outcome data. Interventions and outcome data will be collected for hospitalised children. For all children, follow-up at 14 and 90 days will collect information on further medical care received, and long-term sequelae, respectively. Statistical models will be designed to identify risk factors for infection and severe outcomes.

Ethics and dissemination Sites will seek ethical approval locally, and informed consent will be obtained. There is no direct risk or benefit of study participation. Weekly interim analysis will allow for real-time data sharing with regional, national, and international policy makers. Harmonisation and sharing of investigation materials with WHO, will contribute to synergising global efforts for the clinical characterisation of paediatric COVID-19. Our findings will enable the implementation of countermeasures to reduce viral transmission and severe COVID-19 outcomes in children.

Trial registration number NCT04330261

  • epidemiology
  • paediatric a&e and ambulatory care
  • paediatric infectious disease & immunisation
  • paediatric intensive & critical care
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Footnotes

  • ALF and TAF are joint first authors.

  • NK and SBF are joint senior authors.

  • Contributors SF, TF, NK, TK, SD and AF conceptualised the study and formulated the initial study protocol. SD, SM, MS, DJT, MN, DP, AP, TK, RM, LA and KK further developed and provided critical feedback on the study protocol. AF and SF drafted the manuscript. All authors edited and approved the final version of the manuscript.

  • Funding This work is supported by a Canadian Institutes of Health Research (CIHR) 2019 Novel Coronavirus (COVID-19) Rapid Research Funding Opportunity - Clinical Management Operating Grant (Number: OV2-170706), an Alberta Children’s Hospital Research Institute seed grant, as well as a University of Calgary-Alberta Health Services, Clinical Research Fund seed grant. ALF is supported by a University of Calgary Eyes High Postdoctoral Fellowship. SF is supported by the Alberta Children’s Hospital Foundation Professorship in Child Health and Wellness. SD is supported by Cure Kids New Zealand. AP is supported by the University of Ottawa Research Chair in Pediatric Emergency Medicine.

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  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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