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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

机译:涉嫌儿童儿童患儿患儿的预期队列研究儿科急诊部门:儿科紧急研究网络(Pern)研究方案

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摘要

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
机译:关于小儿COVID-19简介相对有限的数据是可用的。虽然大部分孩子似乎有轻微或无症状感染,婴幼儿和有合并症在增加经历更严重的疾病,需要住院治疗,由于COVID-19的风险。 SARS-COV-2感染的多系统炎症综合征的发展,但最近不常见的协会已经提高认识小儿SARS-COV-2 infection.Methods和分析小儿急救研究网络,COVID-19队列研究的重要性迅速,全球性的,前瞻性队列研究招生12 500名儿童谁是急性SARS-COV-2感染检测。 47个紧急情况部门12个国家四大洲将参加。在招生,无论SARS-COV-2测试结果,所有的孩子都会有收集相同的信息,包括临床,流行病学,实验室,成像和结果数据。干预和结果数据将被收集住院患儿。对于所有的孩子,后续在14天和90天分别将收集得到进一步的医疗和长期后遗症的信息。统计模型的设计,将确定感染和严重outcomes.Ethics和传播网站的风险因素将在本地寻求伦理委员会批准,并获得知情同意书。有参与研究的直接风险或利益。周中期分析将允许与地区,国家和国际决策者的实时数据共享。协调并与世卫组织的调查材料的共享,将有助于synergising儿科COVID-19的临床表征的全球努力。我们的研究结果将使对策的实施,以减少children.Trial注册号NCT04330261病毒传播和严重COVID-19的结果

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