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

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ClinicalTrials.gov Identifier: NCT03255369
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Oswaldo Cruz Foundation

Brief 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.

Condition or disease Intervention/treatment
ZIKA VIRUS INFECTION Child Development Microcephaly Other: Child exposed Zika virus proved

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Vertical Exposure to Zika Virus and Its Consequences for Child Neurodevelopment: Cohort Study in Fiocruz/IFF
Actual Study Start Date : January 2, 2016
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2019


Group/Cohort Intervention/treatment
Child exposed Zika virus proved
child born to mothers with proved zika virus in pregnancy by RT-PCR
Other: Child exposed Zika virus proved
There will be applied Bayley Teste 3rd edition
Other Name: Child exposed Zika virus suspected

Child exposed to zika virus suspected
Child born with symptoms similar to babies proved exposed to zika virus but mothers without symptoms or positive RT-PCR
Other: Child exposed Zika virus proved
There will be applied Bayley Teste 3rd edition
Other Name: Child exposed Zika virus suspected

Normal Child
Normal child from mothers without Zika (IgG and IgM negative)
Other: Child exposed Zika virus proved
There will be applied Bayley Teste 3rd edition
Other Name: Child exposed Zika virus suspected




Primary Outcome Measures :
  1. Microcephaly and/or delay in development [ Time Frame: 36 months of age ]
    Microcephaly at birth or delay in development in Bayley test 3rd edition at 12, 18 and between 24-36 months of age


Secondary Outcome Measures :
  1. ocular injury and cognitive disorder in Bayley Test 3rd edition [ Time Frame: 36 months of age ]
    ocular injury in eye exam by indirect ophtalmoscopia registe by RetCam associated with cognitive disorder

  2. Hearing injury and language delay in Bayley Test 3rd edition [ Time Frame: 36 monthsof age ]
    deaphness or BERA abnomalities associated to language disorder


Biospecimen Retention:   Samples With DNA
Urine and blood for RT-PCR Blood for IgG and IgM Saliva for RT-PCR placenta oral swab for genetic studies fetal tissues stillborn for necropsy CSF and amniotic fluid if affected babies breastmilk


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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

The exposure will be confirmed by the positivity in diagnostic tests (PCR or serological tests).

Women with and without symptoms will have theirblood sampled for serological tests in the three trimesters of pregnancy and at birth.

The pregnant women in the cohort presenting positive results for specifictests (PCR in the acute phase and serological tests later) will be considered exposed to infection whereas pregnant women with negative results will be considered not exposed.

Criteria

Inclusion Criteria:

The study population will be composed of pregnant women who present symptoms compatible with ZIKAV infection, with skin rash, arthralgia-associated fever, myalgia, non-purulent conjunctivitis, or headache and asymptomatic pregnant women identified at the same time of possibility of exposure. We will include patients with RT- PCR positive.

All pregnant women who are in the prenatal follow up at IFF and CSGSF, irrespective of the gestational age, are elegible as a not exposed in the beginning.

Children born during the outbreak by mothers with confirmed infection, suspected infection and normal pregnancy

Exclusion Criteria:

Pregnant women with chromosomal abnormalities detected during fetal life or birth will be excluded.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255369


Contacts
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Contact: Maria E Moreira, MD 552125541918 bebeth@iff.fiocruz.br
Contact: Zilton Vasconcelos, PhD 552125541919 zvasconcelos@gmail.com

Locations
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Brazil
Instituto Fernandes Figueira/Fiocruz Recruiting
Rio de Janeiro, RJ, Brazil, 22250020
Contact: Maria E Moreira, MD    552125541918    bebeth@iff.fiocruz.br   
Contact: Marcos Pone, MD    552125541700    mpone@iff.fiocruz.br   
Sponsors and Collaborators
Oswaldo Cruz Foundation
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
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Principal Investigator: Maria E Moreira, MD Fundação Oswaldo Cruz

Additional Information:

Publications of Results:
Other Publications:

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Responsible Party: Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT03255369     History of Changes
Other Study ID Numbers: 52675616.0.0000.5269
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: we will share the data with Brazilian Minister of Health, WHO and European ZikaPlane consortium
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 3 years
Access Criteria: only the principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oswaldo Cruz Foundation:
Zika virus
Microcephaly
Child
pregnancy
Additional relevant MeSH terms:
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Zika Virus Infection
Microcephaly
Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Malformations of Cortical Development, Group I
Malformations of Cortical Development
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities