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Neurodevelopment Outcome of Newborns Exposed to Zika Virus (ZIKV) in Utero

NCT02943304 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 284

Last updated 2023-01-09

No results posted yet for this study

Summary

This prospective cohort study will determine the natural history of fetal exposure to Zika virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment outcome. Exposure of the fetus will be determined by maternal symptomatology, RT-PCR ZIKV (blood and urine) and serologic test specific for ZIKV. Neonates will be classified according to trimester of infection and as exposed and unexposed to ZIKV.

Conditions

  • Microcephaly
  • Mental Retardation

Interventions

OTHER

Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Universidad Industrial de Santander

    lead OTHER

Principal Investigators

  • Mario A Rojas, MD, MPH · Professor of Pediatrics

  • Luz A Gutierrez, MD · Universidad Industrial de Santander

  • Luis A Diaz, MD, MSc · Universidad Industrial de Santander

Eligibility

Min Age
13 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2020-12-15
Completion
2022-12-20

Countries

  • 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 NCT02943304 on ClinicalTrials.gov