Article Text
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.
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