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Neurodevelopmental Outcomes in ZIKV-Exposed Children

NCT04398901 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 204

Last updated 2025-07-03

No results posted yet for this study

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 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.

Conditions

  • Zika Virus
  • Congenital Zika Syndrome
  • Congenital Infection
  • Child Development

Interventions

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.

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Children's National Research Institute

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States
  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04398901 on ClinicalTrials.gov