Journal of Clinical Trials
Open Access

Abstract

Health Outcomes of Children Born/Suspected with Zikv: Protocol for the Zikaction Paediatric Registry in Latin America and the Caribbean

Elisa Ruiz-Burga*, Isadora Cristina de Siqueira, Roxanne Melbourne-Chambers, Rosa Maria Bologna, Celia DC Christie, Griselda Berberian, Antoni Soriano-Arandes, Heather Bailey, Paulette Palmer, Andrea Oletto, Breno Lima de Almeida, Maria Lucia Costa Lage, Carlo Giaquinto and Claire Thorne

Background: Although the number of Zika Virus (ZIKV) cases has substantially declined in Latin America and the Caribbean since the 2015-2016 outbreaks, the cohort of children born at that time and affected by Congenital Zika Syndrome (CZS) are now around 4-5 years old and experiencing an ongoing impact on their health and development. Gaps in our understanding remain regarding the outcomes of ZIKV exposure in utero and congenital infection and the consequences of Congenital Zika Syndrome (CZS) for health throughout childhood.
Methods: The ZIKAction Paediatric Registry is an international multi-centre registry of infants and children with documented ZIKV exposure in utero (i.e., born to mother with confirmed infection in pregnancy) and/or with confirmed or suspected congenital ZIKV infection. Clinical teams at participating sites in Argentina, Brazil and Jamaica conduct retrospective case note reviews of children eligible for inclusion in the Registry and enter pseudonymised data into a central Registry database, with additional data collected prospectively on routine followup at some sites. Data collected will include sociodemographic, maternal and pregnancy information, delivery information and newborn assessment, paediatric clinical assessments (physical, neurological, developmental, ophthalmological, audiological), and laboratory results conducted as part of local standard of care. The ZIKAction Paediatric Registry network will conduct pooled analyses to address questions relating to characteristics, health and neurodevelopmental outcomes of this population. The Registry is embedded within a larger programme of research studies conducted by ZIKAction.
Discussion: As the health outcomes of children affected by ZIKV continue to unfold, this paediatric registry will provide comprehensive data on their clinical and neurodevelopmental outcomes, growth and management, as well as on later sequelae. This will inform their support and care and provide potential insights on pathogenesis of the disease, of importance to currently affected families and for the response to possible future outbreaks. It will highlight the service needs of the affected populations in Latin America and the Caribbean and allow the identification of potential participants for future studies.

Published Date: 2021-08-30; Received Date: 2021-08-10