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, 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

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.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Locations of 47 participating PERN-COVID-19 study sites (blue dots) against a world map highlighting number of cases reported, by country, over the past 7 days (map adapted from reference . PERN, Paediatric Emergency Research Network.
Figure 2
Figure 2
PERN-COVID-19 study participation timeline with data collection events. ED, emergency department; PERN, Paediatric Emergency Research Network.

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