Child Development Clinical Trial
— ZIKVIRUSIFFOfficial title:
Vertical Exposure to Zika Virus and Its Consequences for Child Neurodevelopment: Cohort Study in Fiocruz/IFF
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 3 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Fernandes Figueira/Fiocruz | Rio de Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
Oswaldo Cruz Foundation | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ) |
Brazil,
Brasil P, Pereira JP Jr, Moreira ME, Ribeiro Nogueira RM, Damasceno L, Wakimoto M, Rabello RS, Valderramos SG, Halai UA, Salles TS, Zin AA, Horovitz D, Daltro P, Boechat M, Raja Gabaglia C, Carvalho de Sequeira P, Pilotto JH, Medialdea-Carrera R, Cotrim da Cunha D, Abreu de Carvalho LM, Pone M, Machado Siqueira A, Calvet GA, Rodrigues Baião AE, Neves ES, Nassar de Carvalho PR, Hasue RH, Marschik PB, Einspieler C, Janzen C, Cherry JD, Bispo de Filippis AM, Nielsen-Saines K. Zika Virus Infection in Pregnant Women in Rio de Janeiro. N Engl J Med. 2016 Dec 15;375(24):2321-2334. Epub 2016 Mar 4. — View Citation
Chimelli L, Melo ASO, Avvad-Portari E, Wiley CA, Camacho AHS, Lopes VS, Machado HN, Andrade CV, Dock DCA, Moreira ME, Tovar-Moll F, Oliveira-Szejnfeld PS, Carvalho ACG, Ugarte ON, Batista AGM, Amorim MMR, Melo FO, Ferreira TA, Marinho JRL, Azevedo GS, Leal JIBF, da Costa RFM, Rehen S, Arruda MB, Brindeiro RM, Delvechio R, Aguiar RS, Tanuri A. The spectrum of neuropathological changes associated with congenital Zika virus infection. Acta Neuropathol. 2017 Jun;133(6):983-999. doi: 10.1007/s00401-017-1699-5. Epub 2017 Mar 22. — View Citation
Halai UA, Nielsen-Saines K, Moreira ML, de Sequeira PC, Junior JPP, de Araujo Zin A, Cherry J, Gabaglia CR, Gaw SL, Adachi K, Tsui I, Pilotto JH, Nogueira RR, de Filippis AMB, Brasil P. Maternal Zika Virus Disease Severity, Virus Load, Prior Dengue Antibodies, and Their Relationship to Birth Outcomes. Clin Infect Dis. 2017 Sep 15;65(6):877-883. doi: 10.1093/cid/cix472. — View Citation
Zin AA, Tsui I, Rossetto J, Vasconcelos Z, Adachi K, Valderramos S, Halai UA, Pone MVDS, Pone SM, Silveira Filho JCB, Aibe MS, da Costa ACC, Zin OA, Belfort R Jr, Brasil P, Nielsen-Saines K, Moreira MEL. Screening Criteria for Ophthalmic Manifestations of — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microcephaly and/or delay in development | Microcephaly at birth or delay in development in Bayley test 3rd edition at 12, 18 and between 24-36 months of age | 36 months of age | |
Secondary | ocular injury and cognitive disorder in Bayley Test 3rd edition | ocular injury in eye exam by indirect ophtalmoscopia registe by RetCam associated with cognitive disorder | 36 months of age | |
Secondary | Hearing injury and language delay in Bayley Test 3rd edition | deaphness or BERA abnomalities associated to language disorder | 36 monthsof age |
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