An observational study in Zika Virus, Congenital Zika Syndrome and Congenital Infection, sponsored by Children's National Research Institute. Enrolling by invitation at 2 sites in 2 countries. Open to participants aged 3 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Children's National Research Institute · Observational
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.
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 assessment scores in children exposed to ZIKV in utero who are normal appearing differ from norms. The investigators hypothesize that ZIKV-exposed normal appearing children will have lower multi-domain developmental assessment scores compared to normative samples. The investigators hypothesize that the presence of mild postnatal non-specific cranial US findings is associated with persistent lower developmental assessment scores compared to ZIKV-exposed children who had normal cranial US and quantitative imaging will find structural and functional brain differences between ZIKV-exposed children and controls..
The investigators will perform a prospective developmental outcome study at 2 sites: 1) Department of Atlántico, Colombia through collaboration with BIOMELAB, the research center of Dr. Carlos Cure, and 2) Children's National, Washington, DC.
The objective of the study is to determine whether children who were exposed to ZIKV in utero and who do not have CZS have abnormalities in neurodevelopment during early childhood and at school age.
The primary outcome at early childhood will be neurodevelopmental assessment scores at age 3 and 4 years. Scores will be compared between Zika-exposed children and controls. The primary outcome at school age will be neurodevelopmental assessment scores at age 5 and 7 years and quantitative brain MRI at 7 years.
78 studies on the registry are indexed under Zika Virus Infection; 8 are open to participants now.
This study's planned enrollment of 204 is below the median of 600 across 31 observational studies indexed under Zika Virus Infection.
Browse Zika Virus Infection studies →Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.
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Zika-exposed children at 3-4 years of age (will be enrolled and studied up to age 8 years) Non-exposed controls at 4 to 5 years of age
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Zika-exposed cohort:
Non-ZIKV exposed Controls:
Exclusion Criteria:
Zika-exposed cohort:
Non-ZIKV exposed controls:
Seventy children in Colombia were previously enrolled as part of a fetal-neonatal neuroimaging study in 2016-2017 and were from Department of Atlantico, Colombia on the Caribbean coast. Eligible children had prior normal fetal MRI and fetal US, normal birth head circumference, normal clinical exam, no more than mild non-specific postnatal imaging findings, and are thus without findings of CZS.
Other: Neurodevelopmental assessments
The investigators will enroll 70 non-ZIKV exposed children, age 4 to 5 years, in Department of Atlántico, Colombia with birth dates prior to March 31, 2016. Based on the arrival of ZIKV to Colombia in November 2015, this date would ensure a control cohort without congenital ZIKV exposure in the first half of gestation and unlikely during any of the pregnancy.
Other: Neurodevelopmental assessments
The US cohort either presented during pregnancy or after birth and sought clinical care with the Children's National Congenital Zika Program in Washington, DC and were ZIKV-exposed.
Other: Neurodevelopmental assessments
The investigators will enroll 32 non-ZIKV exposed children, age 4 years, in Washington, DC.
Other: Neurodevelopmental assessments
The investigators will evaluate multiple domains of neurodevelopment at age 3, 4, 5 and 7 years using parental questionnaires and child exams. At age 7 years, the children will have a non-sedated quantitative brain MRI.
Neurodevelopmental assessment at age 4 years
PEDI-CAT score
Time frame: 4 years of age
Executive function
BRIEF-2 score
Time frame: 5 and 7 years of age
Motor function assessment
MABC-2 score
Time frame: 5 and 7 years of age
Brain maturation
Quantitative brain MRI volumetric measurement
Time frame: 7 years of age
Motor function assessment
MABC-2 score
Time frame: 4 years of age
Intellectual ability
Age-appropriate Wechsler
Time frame: 5 and 7 years of age
Plan to share: Undecided — Undecided at this time
Started Nov 2020 (actual). Primary completion is estimated for Dec 2025, 61 months after the start.
Of 22 observational studies under Zika Virus Infection, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 52. This study's planned 61 months is above that.
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