Status:
ENROLLING_BY_INVITATION
Neurodevelopmental Outcomes in ZIKV-Exposed Children
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
Thrasher Research Fund
National Institutes of Health (NIH)
Conditions:
Zika Virus
Congenital Zika Syndrome
Eligibility:
All Genders
3-7 years
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04398901
Start Date
November 23 2020
End Date
December 31 2025
Last Update
July 3 2025
Active Locations (2)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
2
Biomelab
Barranquilla, Atlántico, Colombia