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Last Updated: 29/05/2024

Clinical characteristics and outcomes of children potentially infected by SARS-CoV-2 presenting to pediatric emergency departments

Objectives

Enable policymakers to make rapid evidence-based adaptations to case screening and management procedures that will then allow for the earlier identification of children at high risk of SARS-CoV-2 infection and severe COVID-19 outcomes.

  • To identify risk factors associated with children having confirmed SARS-CoV-2 infection, and/or severe COVID-19 outcomes.

Primary:

  1. Describe and compare characteristics of confirmed SARS-CoV-2 infected children with symptomatic test-negative children.

Secondary: 

  1. Describe and compare confirmed SARS-CoV-2 infected children with mild versus severe COVID-19 outcomes;
  2. Describe healthcare resource utilization for, and outcomes of, screening and care of pediatric COVID-19 internationally, alongside regional public health policy changes.
Principal Institution

University of Calgary, Canada

Principal Investigators / Focal Persons

Stephen B. Freedman
Nathan Kupperman
Todd Florin

Rationale and Abstract

The manifestations of COVID-19 in children are not yet well understood and may be atypical when compared to adults. We propose to carry out a two-year global prospective study that will enroll and follow-up children with suspected COVID-19 from 50 participating emergency departments (ED) across 19 countries. Patient epidemiological and demographic information, clinical characteristics, and disease outcomes will be collected at the time of ED admission, during the course of illness, and at three weeks and three months after enrollment, using WHO-compliant case report forms. Statistical analysis of the collected data will allow for the identification of risk factors associated with children having confirmed SARS-CoV-2 infection, and/or severe COVID-19 outcomes. In order to enable rapid implementation, this study will be built as a parallel study that borrows the infrastructure from an ongoing study – the called Pediatric Emergency Research Network (PERN)-Pneumonia study, which has ethics approval, a centralized database, data sharing agreements, and established study teams that are actively enrolling children in 70 sites worldwide. Our multidisciplinary team of investigators includes pediatric infectious disease and emergency medicine clinicians, epidemiologists, statisticians, and public health leaders (from PHAC and the CDC), all with extensive experience pertaining directly to the research topic. As data will be shared in real-time with appropriate national and international authorities, this study will enable policymakers to make rapid evidence-based adaptations to case screening and management procedures that will then allow for the earlier identification of children at high risk of SARS-CoV-2 infection and severe COVID-19 outcomes. Furthermore, the establishment of this global multi-site study will be the first trial of a rapid PERN response to a novel virus, which, applying lessons-learned, can be urgently reactivated for future public health emergencies.

Study Design

A two-year global multi-centre prospective study that will enroll and follow-up children with suspected COVID-19 from 50 participating emergency departments (ED).

Study Type  : Observational
Estimated Enrollment  : 12500 participants
Observational Model: Cohort
Time Perspective: Prospective

Methods: This prospective observational study will occur in 50 emergency departments across 11 countries. We will enroll 12,500 children who meet institutional screening guidelines and undergo SARS-CoV-2 testing. Data collection focuses on epidemiological risk factors, demographics, signs, symptoms, interventions, laboratory testing, imaging, and outcomes. Collection will occur at enrollment, 14 days, and 90 days. Statistical analysis of the collected data will allow for the identification of risk factors associated with children having confirmed SARS-CoV-2 infection, and/or severe COVID-19 outcomes.

Timeline: Recruitment will last for 12 months (worst-case model) and will begin within 7-14 days of funding notification after an ongoing expedited review of ethics and data sharing agreements.

Impact: Results will be shared in real-time with key policymakers, enabling rapid evidence-based adaptations to pediatric case screening and management.

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