Neurodevelopmental Outcomes in ZIKV-Exposed Children
Enrolling by invitation
Conditions studied: Zika Virus, Congenital Zika Syndrome, Congenital Infection, Child Development
In brief
In this study the investigators will follow the neurodevelopmental outcome of children with in utero ZIKV exposure who do not have microcephaly or severe abnormalities consistent with Congenital Zika Syndrome. The ZIKV-exposed children will be compared to non-ZIKV exposed controls. Children will be assessed at age 3 and 4 years using standardized neurodevelopmental assessments. Children will also have neurodevelopmental assessment at age 5 and 7 years along with a brain MRI at age 7 years.
Key facts
- Study ID
- NCT04398901
- Run by
- Children's National Research Institute
- People needed
- 204
- Starts
- 2020-11-23
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-07-03
Who can join
Age: 3 and older, up to 7. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Children's National Hospital — Washington D.C., District of Columbia, United States
- Biomelab — Barranquilla, Atlántico, Colombia
Full record on ClinicalTrials.gov
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