Cohort Profile: Congenital Zika virus infection and child neurodevelopmental outcomes; Zika en Embarazadas y Niños (ZEN) cohort study in Colombia.

Zika en Embarazadas y Ninos (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 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. 1519 pregnant women and 287 partners were enrolled from three departments within Colombia between February 2017 and January 2018. 1108 infants born to the pregnant women were enrolled in the study and followed to 6 months. Data include baseline questionnaires at enrollment, repeated symptoms and study follow-up questionnaires, lab testing to detect ZIKV and other congenital infections, medical record abstraction, infant physical, eye and hearing exams and developmental screeners. Follow-up of 850 mother-child dyads occurred at 9, 12, and 18 months, with developmental screenings, physical exams and parent questionnaires. Data will be pooled with those from other prospective cohort studies for an individual participant data meta-analysis on ZIKV infection during pregnancy and characterize pregnancy outcomes and sequelae in children.