Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol
Santiago Mintegi,
Nathan Kuppermann,
Daniel Joseph Tancredi,
Lilliam Ambroggio,
Anna L. Funk,
Todd A. Florin,
Stuart R. Dalziel,
Marina I. Salvadori,
Mark I. Neuman,
Daniel C. Payne,
Amy C. Plint,
Terry P. Klassen,
Richard Malley,
Kelly Kim,
Stephen B. Freedman
Affiliations
Santiago Mintegi
Pediatric Emergency Department, Biocruces Bizkaia Health Research Institute, Hospital Universitario Cruces, Barakaldo, Spain
Nathan Kuppermann
Departments of Emergency Medicine and Pediatrics, University of California Davis School of Medicine, Sacramento, California, USA
Daniel Joseph Tancredi
Department of Pediatrics, University of California Davis, Davis, California, USA
Lilliam Ambroggio
Sections of Emergency Medicine, Department of Pediatrics, Childrens Hospital Colorado, University of Colorado, Denver, Colorado, USA
Anna L. Funk
Department of Pediatrics, Alberta Childrens Hospital Research Institute, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
Todd A. Florin
Division of Emergency Medicine, Ann and Robert H. Lurie Childrens Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Stuart R. Dalziel
Departments of Surgery and Paediatrics: Child and Youth Health, The University of Auckland, Auckland, Auckland, New Zealand
Marina I. Salvadori
Public Health Agency of Canada, Ottawa, Ontario, Canada
Mark I. Neuman
Division of Emergency Medicine, Boston Childrens Hospital, Harvard Medical School, Boston, Massachusetts, USA
Daniel C. Payne
National Center for Emerging Zoonotic Infectious Diseases, Division of Foodborne Waterborne and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
Amy C. Plint
Department of Pediatrics and Emergency Medicine, University of Ottawa, Ottawa, Ontario, Canada
Terry P. Klassen
Childrens Hospital Research Institute of Manitoba, Department of Pediatrics, University of Manitoba, Winnipeg, Manitoba, Canada
Richard Malley
Division of Infectious Disease, Boston Childrens Hospital, Harvard Medical School, Boston, Massachusetts, USA
Kelly Kim
Department of Pediatrics, Alberta Childrens Hospital Research Institute, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
Stephen B. Freedman
Pediatrics, Cumming School of Medicine, Alberta Childrens Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada
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
