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Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol
- Source :
- BMJ Open, BMJ Open, Vol 11, Iss 1 (2021), BMJ open, vol 11, iss 1
- Publication Year :
- 2021
- Publisher :
- BMJ Publishing Group, 2021.
-
Abstract
- IntroductionRelatively 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 analysisThe 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 disseminationSites 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 numberNCT04330261
- Subjects :
- Research design
International Cooperation
Psychological intervention
lcsh:Medicine
0302 clinical medicine
Informed consent
Risk Factors
Epidemiology
030212 general & internal medicine
Prospective Studies
Aetiology
Prospective cohort study
Child
Lung
Pediatric
Emergency Service
Pediatric Emergency Medicine
General Medicine
3. Good health
Hospitalization
Infectious Diseases
Research Design
Public Health and Health Services
epidemiology
Patient Safety
Infection
Emergency Service, Hospital
Cohort study
medicine.medical_specialty
Clinical Trials and Supportive Activities
Clinical Sciences
paediatric infectious disease & immunisation
Vaccine Related
Hospital
03 medical and health sciences
Pediatric emergency medicine
Clinical Research
Biodefense
030225 pediatrics
medicine
Humans
Intensive care medicine
Other Medical and Health Sciences
paediatric a&e and ambulatory care
business.industry
SARS-CoV-2
Prevention
paediatric intensive & critical care
lcsh:R
COVID-19
Interim analysis
Emerging Infectious Diseases
Good Health and Well Being
business
2.4 Surveillance and distribution
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Volume :
- 11
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....f6069002abff8ead7b9e849dbad20e25