Project Description

International Cohort Study of Children Born to Women Infected with Zika Virus During Pregnancy (ZIP 2.0) RTI and will serve as Data Coordinating Center (DCC) for the ZIP 2.0 Study, titled "International Cohort Study of Children Born to Women Infected with Zika Virus during Pregnancy". RTI and Project Developer Brittany Goode will support the development of case report fonns (CRFs), study definitions, and the data management system (OMS) in REDCap, available as both a central and distributed system in English, Spanish and Portuguese, for 6 sites in Latin America. In addition, RTI will develop and implement data edits for key variables, produce monitoring reports and respond to ad hoc requests for data reports. RTI will facilitate routine conference calls and site visits required to carry out the implementation and governance of the ZIP 2.0 protocol. The ZIP 2.0 database will meet FISMA IT security requirements as outlined in Task Order 6. ZIP 2.0 is an extension of the Zika in Infants and Pregnancy (ZIP) study protocol that will continue the longitudinal follow-up of up to 400 children. Of the 400 children, approximately 200 were born to women with documented Zika virus infection during their pregnancy and 200 were born to women without documented Zika virus infection during their pregnancy. Participants enrolled will be followed for up to 3.5 years of age. The primary aims of the ZIP 2.0 study are to (1) determine the long-term neurodevelopmental outcomes among children born to women with documented Zika virus infection during their pregnancy, and (2) compare growth, vision, hearing, and neurodevelopment among children exposed to Zika virus in utero compared with unexposed children.

Project Partners
Altino Ventura Foundation
Project Open
Open