FOLLOW-UP OF ZIP 2.0 CHILD COHORT WITH INTEGRATION AND ANALYSIS OF DATA AND SAMPLES FROM THE SIKA IN INFANT AND PREGNANCY (ZIP) STUDY.

Zika virus (ZIKV) is an arbovirus (vector-borne virus) of the genus Flaviviridae. Until recently , infections were thought to be mild and self-limiting. Since 2015 however, ZIKV infections have been associated with an increase in microcephaly and other birth defects in newborns following infection of the mother during pregnancy. ZIKV also has been associated with Guillain-Barre Syndrome in adults. Increasing evidence points to ZIKV as the agent responsible for a variety of birth defects in newborns of mothers who become infected during pregnancy . The relationship of ZIKV infections in pregnant women with adverse outcomes of pregnancy is the subject of ongoing evaluation. Studies to date of infants born to infected women focus on those born with serious birth defects that constitute the congenital Zika syndrome. However, whether there are latent effects on growth and development of infants who are not born with congenital Zika syndrome, and what those effects may be, is presently unknown. Longitudinal studies of infants born to Zika-infected pregnant women therefore arc necessary to assess the broader spectrum of possible manifestations of intrauterine or intrapartum Zika exposure , and their natural history. In 2016 , NIH initiated a large, multicenter, international observational study of the epidemiology natural history, and pathogenesis of Zika in infants and pregnancy (the ZIP Study) . The ZIP Study followed infants born to women at risk for Zika infection during pregnancy only through the infants' first 12 months of life and will complete its last patient last visit December 2019. In 2018, NIH initiated the ZIP 2.0 cohort study of Zika exposed children and unexposed control children from the ZIP Study or similar studies beyond infancy into early childhood to evaluate the effects of Zika on child growth and development. This task order addresses NlH's requirement lo continue follow-up of ZIP 2.0 infants and children and to combine and consolidate into ZIP 2.0 final and complete data and biospecimens from the ZIP study. SCOPE To conduct the initial phase of the ZIP 2.0 cohort study of children born to women in the Zika in Infants and Pregnancy (ZIP) Study, including final completion of the ZIP Study and integration and analysis of ZIP Study data and samples into ZIP 2.0. Specifically, this includes: (1) completion and consolidation of ZIP study data and biospecimens into ZIP 2.0 study startup activities and (2) implementation of the initial phase of the ZIP 2.0 Stud y, including services and supp011 related to protocol development, data collection, database preparation, data analysis and preparation of clinical study reports.