Back to search results

Neurodevelopmental Outcomes in Children Exposed to Zika Virus

This observational study is looking at the long-term brain development of children who were exposed to the Zika virus (ZIKV) before birth, but did not have severe birth defects like microcephaly (a small head). Researchers want to understand if these children, who appear normal at birth, might still have differences in their development compared to children not exposed to Zika. You can join if you are a child between 3 and 7 years old who was exposed to Zika in the womb and met specific health criteria at birth, or if you are a child not exposed to Zika. The study will assess neurodevelopment (brain and nervous system development) at ages 4, 5, and 7 years. At age 7, children will also have a brain MRI scan. The study aims to see if Zika-exposed children have lower developmental scores.

Study design
This is an observational study with a planned enrollment of 204 participants. It compares children exposed to Zika in the womb to those not exposed.
What's involved
Participants will have neurodevelopmental assessments at ages 3, 4, 5, and 7 years, which include parent questionnaires and child exams. At age 7, children will also have a non-sedated quantitative brain MRI.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until at least 7 years of age, with assessments at 4, 5, and 7 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04398901

Neurodevelopmental Outcomes in ZIKV-Exposed Children

Enrolling by Invitation
Not specifiedAges 3–7Observational
Children's National Research Institute
~204 participants
Updated 2025-07-03 on ClinicalTrials.gov
What's tested:Neurodevelopmental assessments

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurodevelopmental assessment at age 4 years
Measured over 4 years of age
+3 more outcomes measured

Conditions

Zika Virus
Congenital Zika Syndrome
Congenital Infection
Child Development

Explore related trials

Zika Virus

Where it's being run

2 sites across 2 states
District of Columbia1
Atlántico1

Study leadership

  • Sarah B Mulkey, MD, PhD · PRINCIPAL_INVESTIGATOR · Children's National Research Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
healthy
no chronic medical conditions
no developmental concerns
born at term (\>= 37 weeks)
birth date prior to March 31, 2016 (Colombian controls)

Exclusion

another diagnosis that would impact neurodevelopment
chronic medical condition with in-patient hospitalization since birth
under care of a medical specialty provider for a chronic medical condition
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

What this trial measures

  • Neurodevelopmental assessment at age 4 years4 years of age

    PEDI-CAT score

  • Executive function5 and 7 years of age

    BRIEF-2 score

  • Motor function assessment5 and 7 years of age

    MABC-2 score

  • Brain maturation7 years of age

    Quantitative brain MRI volumetric measurement