Identifying risk factors for neurological complications and monitoring long-term neurological sequelae: protocol for the Guangzhou prospective cohort study on hand-foot-and-mouth disease.

INTRODUCTION: Hand-foot-and-mouth disease (HFMD) is a paediatric infectious disease that is particularly prevalent in China. Severe HFMDs characterised by neurological involvement are fatal and survivors who have apparently fully recovered might still be afflicted later in life with neurocognitive impairments. Only when a well-designed, prospective cohort study is in place can we develop clinical tools for early warning of neurological involvement and can we obtain epidemiological evidence regarding the lingering effects of the sequelea.

METHODS AND ANALYSIS: A prospective, hospital-based cohort study is underway in Guangzhou, China. Clinical data and biosamples from hospitalised children (<14 years of age) with an admission diagnosis of HFMD will be collected to determine risk factors for subsequent neurological involvement. Clinical tools for early detection of severe HFMDs will be developed by integrating clinical and biological information. Questionnaire surveys and neurocognitive assessments will be conducted at discharge and each year in the first 2 years of follow-up and every 2 years afterwards until study participants turn 16 years of age or show no evidence of neurocognitive deficits. The association between childhood enterovirus infection and neurocognitive impairment later in life will be examined.

ETHICS AND DISSEMINATION: A written informed consent from parents/guardians is a prerequisite for study entry. The protocol of this study has been approved by the hospital's ethics committee. Data usage follows the rules of the hospital's data oversight committee. Findings of this study will be disseminated through publications in international peer-reviewed journals and will be presented in academic conferences.

TRIAL REGISTRATION NUMBER: ChiCTR-EOC-17013293; Pre-results.