Cohort profile: congenital Zika virus infection and child neurodevelopmental outcomes in the ZEN cohort study in Colombia

Zika en Embarazadas y Niños (ZEN) is a prospective cohort study designed to identify risk factors and modifiers for Zika virus (ZIKV) infection in pregnant women, partners, and infants, as well as to assess the risk for adverse maternal, fetal, infant, and childhood outcomes of ZIKV and other congenital infections. ZIKV infection during pregnancy may be associated with long-term sequelae. In the ZEN cohort, 1,519 pregnant women and 287 partners were enrolled from 3 departments within Colombia between February 2017 and January 2018, as well as 1,108 infants born to the pregnant women who were followed to 6 months. The data include baseline questionnaires at enrollment; repeated symptoms and study follow-up questionnaires; the results of lab tests to detect ZIKV and other congenital infections; medical record abstractions; infant physical, eye, and hearing exams; and developmental screening tests. Follow-up of 850 mother-child dyads occurred at 9 months, 12 months, and 18 months with developmental screenings, physical exams, and parent questionnaires. The data will be pooled with those from other prospective cohort studies for an individual participant data meta-analysis of ZIKV infection during pregnancy to characterize pregnancy outcomes and sequelae in children.