Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol

Anna L Funk; Todd A Florin; Stuart R Dalziel; Santiago Mintegi; Marina I Salvadori; Daniel Joseph Tancredi; Mark I Neuman; Daniel C Payne; Amy C Plint; Terry P Klassen; Richard Malley; Lilliam Ambroggio; Kelly Kim; Nathan Kuppermann; Stephen B Freedman

doi:10.1136/bmjopen-2020-042121

Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol

BMJ Open. 2021 Jan 15;11(1):e042121. doi: 10.1136/bmjopen-2020-042121.

Authors

Anna L Funk¹, Todd A Florin², Stuart R Dalziel^{3

4}, Santiago Mintegi⁵, Marina I Salvadori⁶, Daniel Joseph Tancredi⁷, Mark I Neuman⁸, Daniel C Payne⁹, Amy C Plint^{10

11}, Terry P Klassen¹², Richard Malley¹³, Lilliam Ambroggio¹⁴, Kelly Kim¹, Nathan Kuppermann¹⁵, Stephen B Freedman¹⁶

Affiliations

¹ Department of Pediatrics, Alberta Children's Hospital Research Institute, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.
² Division of Emergency Medicine, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
³ Departments of Surgery and Paediatrics: Child and Youth Health, The University of Auckland, Auckland, Auckland, New Zealand.
⁴ Children's Emergency Department, Starship Children's Health, Newmarket, Auckland, New Zealand.
⁵ Pediatric Emergency Department, Biocruces Bizkaia Health Research Institute, Hospital Universitario Cruces, Barakaldo, Spain.
⁶ Public Health Agency of Canada, Ottawa, Ontario, Canada.
⁷ Department of Pediatrics, University of California Davis, Davis, California, USA.
⁸ Division of Emergency Medicine, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
⁹ National Center for Emerging Zoonotic Infectious Diseases, Division of Foodborne Waterborne and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
¹⁰ Department of Pediatrics and Emergency Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹¹ Division of Emergency Medicine, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
¹² Children's Hospital Research Institute of Manitoba, Department of Pediatrics, University of Manitoba, Winnipeg, Manitoba, Canada.
¹³ Division of Infectious Disease, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
¹⁴ Sections of Emergency Medicine, Department of Pediatrics, Children's Hospital Colorado, University of Colorado, Denver, Colorado, USA.
¹⁵ Departments of Emergency Medicine and Pediatrics, University of California Davis School of Medicine, Sacramento, California, USA.
¹⁶ Pediatrics, Cumming School of Medicine, Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada [email protected].

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.

Keywords: epidemiology; paediatric a&e and ambulatory care; paediatric infectious disease & immunisation; paediatric intensive & critical care.

Publication types

Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

COVID-19 / diagnosis*
COVID-19 / epidemiology*
Child
Emergency Service, Hospital*
Hospitalization
Humans
International Cooperation*
Pediatric Emergency Medicine / organization & administration*
Prospective Studies
Research Design
Risk Factors
SARS-CoV-2 / isolation & purification

Associated data

ClinicalTrials.gov/NCT04330261