ZIP 2.0 STUDY CHILD COHORT WITH INTERIM ANALYSIS OF AGE 30 MONTHS DATA

ZIP 2.0 研究儿童队列，对 30 个月龄数据进行中期分析

• 批准号: 10396161
• 负责人: BARBARA DRIVER
• 金额: $ 233.06万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10396161
• 关键词: Address; Age; Age-Months; Anatomy; Arboviruses; Auditory; Behavioral; Brazil; Child; Clinical Research; Cognitive; Cohort Studies; Congenital Abnormality; Data; Data Analyses; Data Collection; Databases; Development; Developmental Delay Disorders; Epidemic; Epidemiology; Evaluation; Exposure to; Flaviviridae; Frequencies; Growth and Development function; Head circumference; Infant; Infection; International; Life; Longitudinal Studies; Microcephaly; Monitor; Mothers; Natural History; Newborn Infant; Observational Study; Outcome; Pathogenesis; Patients; Pregnancy; Pregnant Women; Preparation; Recommendation; Reporting; Risk; Services; United States National Institutes of Health; Virus; Visit; Woman; Work; ZIKA; ZIKV infection; Zika Virus; adverse pregnancy outcome; cohort; comparative; congenital zika syndrome; follow-up; high risk; in utero; infancy; intrapartum; neurodevelopment; prenatal exposure; protocol development; vector-borne

Zika virus (ZIKV) is an arbovirus (vector-borne virus) of the genus Flaviviridae. Infections were thought to be mild and self-limiting until 2015, when an epidemic was observed initially in Brazil of microcephaly and other birth defects in newborns following infection of the mother during pregnancy with Zika virus (ZIKV). Increasing evidence now points to ZIKV as the agent responsible for a variety of birth defects in newborns of mothers who become infected during pregnancy. The relationship of ZIKV infections in pregnant women with adverse outcomes of pregnancy is the subject of ongoing evaluation. Studies to date of infants born to infected women focus on those born with serious birth defects that constitute the congenital Zika syndrome (CZS). Whether there are latent effects on growth and development in infants who are born without CZS to Zika-infected women, and what those effects may be, is unclear. Longitudinal studies of infants born to Zika-infected pregnant women are needed to assess the broader spectrum and natural history of possible manifestations of intrauterine or intrapartum Zika exposure. In 2016, NIH initiated a large, multicenter, international observational study of the epidemiology, natural history, and pathogenesis of Zika in infants and pregnancy (the ZIP Study). The ZIP Study followed infants born to women at risk for Zika infection during pregnancy only through the infants’ first 12 months of life and completed its last patient last visit December 2019. In 2018, NIH initiated the ZIP 2.0 cohort study of Zika exposed children and unexposed control children from the ZIP Study or similar studies, following children beyond infancy to 42 months of age to evaluate the effects of Zika on child growth and development. Recent studies have found that infants who had in utero ZIKV exposure without CZS appear to be at risk for abnormal neurodevelopmental outcomes in the first 18 months of life1 and similarly observed high frequencies of anatomical and neurodevelopmental abnormalities in children without microcephaly who were exposed to ZIKV in utero2. One study found a gradient of risk of development delay according to head circumference, with severely microcephalic children at highest risk for delays while normocephalic ZIKV-exposed children showed similar risk to unexposed control children3. However, several other studies have observed abnormal neurodevelopment in the absence of microcephaly among children with intrauterine ZIKV exposure4,5. Those reports indicate that nearly all such children presented at least one developmental delay and that a significant proportion of children exposed in utero to ZIKV developed mild cognitive delay and auditory behavioral abnormalities.

Zika病毒（ZIKV）是Flaviviridae属的Arbovirus（载体传播病毒）。感染 被认为是温和的，自我限制的，直到2015年，最初观察到流行病 在感染后，在巴西的小头畸形和其他出生缺陷中 寨卡病毒怀孕期间的母亲（ZIKV）。越来越多的证据现在指向Zikv 负责成为母亲的新生儿各种出生缺陷的代理人 在怀孕期间感染。孕妇的ZIKV感染与 怀孕的不利结果是正在进行的评估的主题。婴儿的研究 出生于感染的妇女专注于那些出生的患有严重出生缺陷的人 先天寨卡综合症（CZS）。是否对增长和发展产生潜在影响 在没有CZ的婴儿与Zika感染的妇女的婴儿中，这些影响可能是什么， 不清楚。需要对寨卡病毒感染孕妇出生的婴儿的纵向研究 评估插入术或 原始寨卡病毒暴露。 2016年，美国国立卫生研究院（NIH 婴儿和怀孕的寨卡病毒的流行病学，自然病史和发病机理（拉链 学习）。这项ZIP研究跟随婴儿出生的婴儿在有Zika感染的风险中 仅通过婴儿的头12个月才怀孕，并完成了最后的患者 访问2019年12月。2018年，NIH启动了Zika暴露的ZIP 2.0队列研究 从拉链研究或类似研究的儿童和意外的对照儿童之后 在婴儿期到42个月大的孩子评估寨卡对儿童成长的影响 和发展。 最近的研究发现，在不出现CZ的子宫zikv暴露的婴儿 在Life的前18个月中，有可能有神经发育结果异常的风险1 类似地观察到解剖和神经发育异常的高频 没有小头畸形的儿童在子宫内暴露于ZIKV。一项研究发现 根据头部圈子的发展风险延迟的梯度，严重 延迟风险最高的小头脑儿童，而正常ZIKV暴露儿童 与未暴露的对照儿童显示相似的风险3。但是，其他一些研究有 观察到的神经发育异常在没有小头畸形的情况下 ZIKV的内在ZIKV暴露4,5。这些报告表明，几乎所有这样的孩子都介绍了 至少有一个发育延迟，并且在子宫内暴露于 ZIKV出现了轻度的认知延迟和听觉行为异常。