The clinical spectrum of COVID-19 in neonates and infants: A systematic review protocol

Abstract Background Preliminary data on COVID-19 in the pediatric population has revealed that children account for a milder clinical course and better prognosis compared with adults. However, infants are at the greatest risk within this subset, with studies demonstrating the highest proportion of critical cases in this age group. The clinical spectrum of the disease in these children remains largely unexplored. Similarly, there is a dearth of research on the potential vertical/perinatal transmission of SARS-nCoV and the clinical outcomes of infants born to mothers who have been tested positive for the virus. In this review, we aim to summarize available literature on the clinical spectrum of COVID-19 in neonates and infants. Methodology This review will explore the clinical characteristics of COVID-19 in infants tested positive for SARS-nCoV using RT-PCR assays as well as neonates born to mothers who were detected with the virus during pregnancy. We will conduct a comprehensive search of two large databases, i.e. PubMed and Google Scholar and shortlist published and unpublished (pre-proof and pre-proof accepted) articles in English between 1 st November 2019 and 15 th May 2020 that meet the eligibility criteria. Keeping in view the paucity of data on the study topic, we plan to include all relevant articles irrespective of study design. The findings will be synthesized narratively following an analytical interpretation to capture emerging themes. Discussion Through this systematic review, we hope to provide an evidence-based framework for pediatricians to incorporate into their practice while managing neonates and infants tested positive for COVID-19 or those born to mothers who tested positive for the disease. This will set the stage for prospective clinical research to address the questions that remain unanswered. More importantly, exploring disease pathogenesis and transmission in pediatric patients could provide practical insights to guide future therapeutic and preventative measures and, perhaps, vaccine development. Systematic review registration: This review has been submitted for registration with PROSPERO (acknowledgement of receipt -185333).