Long-term impact of invasive meningococcal disease in children: SEINE study protocol

Abstract

Introduction: Invasive meningococcal disease (IMD) is still an important cause of mortality in children and survivors can have significant long-term disabling sequelae. There are few prospective studies looking at the long term neuropsychological and developmental consequences of IMD in surviving children, and the rate of sequelae may be underestimated. The SEINE study aims to have a more reliable estimate of the real rate of sequelae by assessing the long-term physical, neuropsychological, learning disorders and sensory sequelae of IMD in children and adolescents and by assessing the post-traumatic stress in parents.

Methods and analysis: The SEINE study is a multicentre, prospective, non-randomized, interventional study based on the French bacterial meningitis surveillance network. The study will include 100 children aged from birth to 15 years old, hospitalized in a Paris area paediatric ward for a meningococcal meningitis or a purpura fulminans between 2010 and 2019. The first outcome will assess long-term sequelae (physical, neurological, or sensory) measured by a general clinical and neurological examination, a neurocognitive assessment, learning development, a pure tone audiometry and an ophthalmic examination. The second outcome will assess the long-term post-traumatic stress in parents measured by the Impact of Event Scare Revised questionnaire.

Perspectives: By providing a better estimation of the rate of sequelae in children and offering an adapted follow-up of these children, we believe that the SEINE study will help to improve the management of patients surviving IMD.

Trial registration number: NCT04685850.

Conflict of interest statement

RC and CL received personal fees and non-financial support from Pfizer outside the submitted work. RC reports personal fees from AstraZeneca, GSK, Merck, Pfizer and Sanofi outside the submitted work. MKT reported institutional fees from the GSK group of companies, Pfizer and Sanofi-Pasteur for activities outside the presented work and a patent 630133 issued (with GSK group of companies) CJ reports personal fees from MSD and Nestlé outside the submitted work. AB received personal fees and non-financial support from Sanofi outside the submitted work. All other authors declare no competing interests for this study. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. SEINE study procedure flow chart.