TY - JOUR
T1 - Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments
T2 - A Paediatric Emergency Research Networks (PERN) Study Protocol
AU - Funk, Anna L.
AU - Florin, Todd A.
AU - Dalziel, Stuart R.
AU - Mintegi, Santiago
AU - Salvadori, Marina I.
AU - Tancredi, Daniel Joseph
AU - Neuman, Mark I.
AU - Payne, Daniel C.
AU - Plint, Amy C.
AU - Klassen, Terry P.
AU - Malley, Richard
AU - Ambroggio, Lilliam
AU - Kim, Kelly
AU - Kuppermann, Nathan
AU - Freedman, Stephen B.
N1 - Funding Information:
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.
PY - 2021/1/15
Y1 - 2021/1/15
N2 - 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
AB - 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
KW - epidemiology
KW - paediatric a&e and ambulatory care
KW - paediatric infectious disease & immunisation
KW - paediatric intensive & critical care
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U2 - 10.1136/bmjopen-2020-042121
DO - 10.1136/bmjopen-2020-042121
M3 - Review article
C2 - 33452195
AN - SCOPUS:85099564122
VL - 11
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 1
M1 - 041711
ER -