Vertical Exposure to Zika Virus and Its Consequences for Child Neurodevelopment: Cohort Study in Fiocruz/IFF
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Microcephaly and/or delay in development
研究概览
简要总结
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.
详细描述
The mais goal of the study is to assess the natural history of vertical ZIKV transmission from pregnancy to the end of third year of life and the existence of risk factors associated with the incidence of clinical and neurological disorders, specially microcephaly.
A longitudinal study will be conducted from gestation to the end of the third year of life, during which ZIKV infection will be the main exposure.
Sample size will be 500 children exposed to zika virus. The sample size was calculated for rare events with basis on the usual microcephaly prevalence in Brazil (2:10.000) and expected increase in the number of cases among pregnant women exposed to ZIKAV.
The study will be conducted at the Fernandes Figueira National Institute for Health of Women and Children (IFF). The pregnant women will be selected in the prenatal care clinic at IFF and in the Family Health Strategy units, at Centro de Saúde Escola Germano Sinval Faria (CDEGSF), which are both from FioCruz/RJ. We also will recruit pregnant woman from clinical family of SMS Rio de Janeiro.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Days 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnant women with chromosomal abnormalities detected during fetal life or birth will be excluded.
结局指标
主要结局
Microcephaly and/or delay in development
时间窗: 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
次要结局
- ocular injury and cognitive disorder in Bayley Test 3rd edition(36 months of age)
- Hearing injury and language delay in Bayley Test 3rd edition(36 monthsof age)