International Cohort Study of Children Born to Women Infected with Zika Virus During Pregnancy

This study was an extension of the International Prospective Observational Cohort Study of Zika in Infants and Pregnancy (ZIP Study). It was a prospective longitudinal cohort study that enrolled participants from the ZIP Study and other-approved studies and followed them for up to 3.5 years of age. Participants included children with confirmed or presumptive in-utero exposure to Zika virus and children matched by site, birth sex, and age (based on age at enrollment +/- 6 weeks) without confirmed or presumptive in-utero exposed to Zika virus. The primary aims were to determine the long-term neurodevelopmental outcomes among children born to women with documented ZIKV infection during their pregnancy and compare the long-term effects (e.g. on growth, vision, hearing and neurodevelopment) of confirmed in utero ZIKV-exposure compared to ZIKV-unexposed children. A total of 5 evaluations occurred about every 6 months over about a 2-year period beginning at approximately 18 months of age through 42 months of age.