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Vertical Exposure to Zika Virus and Its Consequences for Child Neurodevelopment (ZIKVIRUSIFF)

NCT03255369 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2018-05-03

No results posted yet for this study

Summary

The recent increase in the number of cases of congenital microcephaly observed in Brazil is a reason of great concern. This increase occurred a few months after Zika virus (ZIKV) was introduced in the country, which was associated with reports of pregnant women presenting fever and rash illness during pregnancy. Thus, the hypothesis of a relationship between ZIKV infection and microcephaly became plausible. However, studies on the pathophysiology of maternal ZIKV infection, its consequences for the fetus, and the development of severe encephalopathy are still needed. Knowledge about the natural history of vertical transmission and its association with changes in fetal development in early life is still scarce. Studies on factors which determine the severity and clinical evolution, such as inflammatory response mechanisms, viral evolution, and development of serological tests to identify ZIKV infection, are still needed. The Aedes aegypti is responsible for the transmission of various types of viruses of interest to human health. Currently, it is primarily responsible for the transmission of the dengue, chikungunya, and ZIKV in epidemic proportions. In addition, it is not yet known whether there is an interaction between these viruses and whether the interaction can determine the severity of the disease. The aim of this study is to evaluate the natural history of ZIKV disease in two cohorts( pregnant women and children) starting with pregnant women or newborns or evennursing mothers, identifying risk biomarkers, mapping the anti-viral inflammatory response, evaluating the molecular evolution of the virus,which areimportant to determine the mechanisms of vertical viral infection and verify children neurodevelopment from birth to the end of 3rd year of life.

Conditions

  • ZIKA VIRUS INFECTION
  • Child Development
  • Microcephaly

Interventions

OTHER

Child exposed Zika virus proved

There will be applied Bayley Teste 3rd edition

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    collaborator OTHER_GOV

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • Maria E Moreira, MD · Fundação Oswaldo Cruz

Eligibility

Min Age
2 Days
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-02
Primary Completion
2018-12-30
Completion
2019-12-30

Countries

  • Brazil

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 NCT03255369 on ClinicalTrials.gov