Abstract
Sepsis and meningitis due to invasive group B Streptococcus (iGBS) disease during early infancy is a leading cause of child mortality. Recent systematic estimates of the worldwide burden of GBS suggested that there are 319,000 cases of infant iGBS disease each year, and an estimated 147,000 stillbirths and young-infant deaths, with the highest burden occurring in Sub-Saharan Africa. The following priority data gaps were highlighted: (1) long-term outcome data after infant iGBS, including mild disability, to calculate quality-adjusted life years (QALYs) or disability-adjusted life years (DALYs) and (2) economic burden for iGBS survivors and their families. Geographic data gaps were also noted with few studies from low- and middle- income countries (LMIC), where the GBS burden is estimated to be the highest. In this paper we present the protocol for a multi-country matched cohort study designed to estimate the risk of long-term neurodevelopmental impairment (NDI), socioemotional behaviors, and economic outcomes for children who survive invasive GBS disease in Argentina, India, Kenya, Mozambique, and South Africa. Children will be identified from health demographic surveillance systems, hospital records, and among participants of previous epidemiological studies. The children will be aged between 18 months to 17 years. A tablet-based custom-designed application will be used to capture data from direct assessment of the child and interviews with the main caregiver. In addition, a parallel sub-study will prospectively measure the acute costs of hospitalization due to neonatal sepsis or meningitis, irrespective of underlying etiology. In summary, these data are necessary to characterize the consequences of iGBS disease and enable the advancement of effective strategies for survivors to reach their developmental and economic potential. In particular, our study will inform the development of a full public health value proposition on maternal GBS immunization that is being coordinated by the World Health Organization.
Highlights
The United Nations Sustainable Development Goals (SDGs) aim to complete the unfinished agenda for child survival and ensure that every child has the opportunity to thrive, including reaching their developmental potential[1,2]
Institutional review boards in each of the operating countries granted ethics approval (Argentina approval number Protocol EGB-1, India approval numbers 11723 (CMC Vellore), 2019–7034 (ICMR); Kenya approval number SERU/CGMR-C/164/3882; Mozambique approval numbers 98/CNBS/2019; South Africa approval number M190241), as well as the institutional review board of the World Health Organization. This multi-country study will provide new data on the consequences of Invasive group B Streptococcus (iGBS), which is responsible for significant morbidity, disability and mortality in infants[9,17]
Mild neurodevelopmental impairment (NDI) may be common, impact families and societies, and are required to estimate disability-adjusted life years (DALYs), which are widely used as metrics to set priorities for resource allocation
Summary
Any reports and responses or comments on the article can be found at the end of the article. Keywords Group B streptococcus, meningitis, sepsis, infants, children, impairment, neurodevelopment, disability, economic, cost. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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