Neurodevelopmental Outcomes in ZIKV-Exposed Children

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

Keywords

ClinConnect Summary

Zika-virus (ZIKV) infection in pregnancy can result in severe brain damage in 4-12% of cases. Children exposed to ZIKV in utero during the years of 2015-2017 are now in early childhood. Children with severe neurologic injury (Congenital Zika Syndrome; CZS) have a poor developmental outcome, however the developmental outcome of apparently normal infants following in utero ZIKV-exposure is not well known. The incidence of abnormal neurodevelopmental outcome in apparently normal children with in utero ZIKV-exposure is not known.

The investigators will determine if neurodevelopmental assessmen...

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