Consequences of COVID-19 infection for child health and wellbeing: protocol for a prospective, observational, longitudinal study in children

Abstract

The novel coronavirus disease 2019 (COVID-19) pandemic has a detrimental impact on the physical and mental health of many children and their families worldwide. Although most children have mild disease, some develop severe complications, with multisystem inflammatory syndrome being the most well-described. Recent reports suggest that COVID-19 may not fully resolve even months after the end of the acute phase. There is a lack of harmonised longitudinal data on short- and long-term consequences of COVID-19 infection in children. Hence, an observational study is needed to evaluate the consequences of COVID-19 in the paediatric population. Methods and analysis This protocol describes a prospective, observational, longitudinal study in paediatric patients previously diagnosed with COVID-19 in hospital and/or primary care/ community settings. The aim of the study is to include children and adolescents (0 to 17 years old) at different sites internationally. Participants will be enrolled and followed up for up to 3 years. Basic (Tier 1) data will include the following: COVID-19 clinical characteristics during acute phase; child comorbidities; treatments received; child or caregiver-reported outcomes on health and wellbeing and impact of daily living; readmission rate. Additional symptom-specific (Tier 2) data may be collected in a subgroup of patients that are experiencing persistent problems. Ethics and dissemination This study will be conducted in accordance with the principles established by the 18th World Medical Assembly and all subsequent amendments and the guidelines for Good Epidemiology Practice. Each individual country joining this study assures that ethics approval are in place and local regulatory requirements met before commencing the study. The anonymised data may be disseminated via publications in peer-reviewed journals, presentations at workshops and conferences, and the public domain by press releases and social media