Neurodevelopmental Outcomes in ZIKV-Exposed Children

Launched by CHILDREN'S NATIONAL RESEARCH INSTITUTE · May 19, 2020

Keywords

ClinConnect Summary

This study is watching whether children who were exposed to Zika virus in the womb (but who did not have the obvious Congenital Zika Syndrome) develop differently as they grow. Researchers will follow these kids from early childhood into school age to see if there are subtle differences in thinking, language, movement, and overall development compared with children who were not exposed to Zika. They will do neurodevelopment tests at ages 3–4 and again at 5–7, and at age 7 there will be a non-sedated brain MRI to look at brain structure. This is an observational study, so no treatment is being given.

Who can join: about 200 children in total, at sites in Barranquilla, Colombia and Washington, DC. The Zika-exposed group includes kids aged roughly 3–4 years whose mothers had Zika during pregnancy (or were suspected to), who had normal brain imaging at birth and normal birth measurements, and who can stay in touch for follow-up. The comparison group includes healthy children born at term before the end of March 2016 with no developmental concerns. Participants will complete a series of developmental tests and questionnaires, with the 7-year-olds also undergoing a brain MRI without anesthesia. Results from the study are not yet available, and enrollment is ongoing.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Zika-exposed cohort:
• • born to mothers with Zika lab confirmation by PCR, IgM, and/or PRNT, or mother was symptomatic for Zika but infection could not be excluded due to late testing and evaluated at Children's National, Washington, DC (USA) or at BIOMELAB, Barranquilla (Colombia)
• • normal fetal neuroimaging
• • normal birth head circumference
• • normal birth clinical exam
• • no more than mild non-specific postnatal cranial ultrasound or brain MRI findings during infancy (if performed)
• • able to be contacted for follow-up
• Non-ZIKV exposed Controls:
• • healthy
• • no chronic medical conditions
• • no developmental concerns
• • born at term (\>= 37 weeks)
• • birth date prior to March 31, 2016 (Colombian controls)
• Exclusion Criteria:
• Zika-exposed cohort:
• • another diagnosis that would impact neurodevelopment
• • abnormal brain MRI (non-specific mild findings are not an exclusion criteria)
• Non-ZIKV exposed controls:
• • chronic medical condition with in-patient hospitalization since birth
• • under care of a medical specialty provider for a chronic medical condition
• • surgery with general anesthesia since birth (brief anesthesia for ear tubes, tonsillectomy, or other minor pediatric procedure is not an exclusion criteria)
• • history of seizure
• • abnormal vision (children wearing corrective lenses are eligible)
• • abnormal hearing affecting language development
• • developmental concerns expressed by caregiver
• • receiving physical, occupational, speech or developmental therapy
• • receiving special education services in school
• • behavioral or psychological condition
• • birth date March 31, 2016 or later (Colombian controls)
• • preterm birth (≤36 weeks)
• • planned relocation of child within 5 years and likely inability to complete study