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.

寨卡病毒（ZIKV）是一种黄病毒科（Flaviviridae）的虫媒病毒。感染 被认为是温和的和自限性的，直到2015年，当最初观察到流行病时， 在巴西，新生儿在感染艾滋病毒后出现小头畸形和其他出生缺陷， 寨卡病毒（ZIKV）是什么？越来越多的证据表明ZIKV是 导致母亲的新生儿出现各种出生缺陷的因素， 在怀孕期间感染。妊娠妇女ZIKV感染与 妊娠的不良后果是持续评估的主题。迄今为止的婴儿研究 受感染妇女所生婴儿的重点是那些出生时有严重先天缺陷的婴儿， 先天性寨卡综合征（CZS）。是否对生长发育有潜在影响 在寨卡病毒感染妇女所生的没有CZS的婴儿中，以及这些影响可能是什么， 还不清楚需要对寨卡病毒感染孕妇所生婴儿进行纵向研究 评估更广泛的范围和自然史的可能表现的宫内或 分娩时接触寨卡病毒 2016年，NIH启动了一项大型、多中心、国际观察性研究， 寨卡病毒在婴儿和孕妇中的流行病学、自然史和发病机制（ZIP 研究）。ZIP研究跟踪了在2015年期间有寨卡感染风险的妇女所生的婴儿。 怀孕仅通过婴儿的前12个月的生活，并完成了其最后一个病人的最后一次 访问2019年12月。2018年，NIH启动了Zika暴露的ZIP 2.0队列研究。 来自ZIP研究或类似研究的儿童和未暴露对照儿童， 从婴儿期到42个月大的儿童，以评估寨卡病毒对儿童生长的影响 发展先行者的要求 最近的研究发现，在子宫内暴露于ZIKV而没有CZS的婴儿出现 在生命的前18个月内有异常神经发育结果的风险1， 同样观察到高频率的解剖和神经发育异常， 在子宫内暴露于ZIKV的无小头畸形的儿童2.一项研究发现， 根据头围的发育延迟风险梯度， 小头症儿童延迟风险最高，而正常头ZIKV暴露儿童 显示出与未接触的对照组儿童相似的风险3。然而，其他一些研究表明， 在没有小头畸形的儿童中观察到异常的神经发育， 子宫内ZIKV检查4，5.这些报告表明，几乎所有这些儿童都在 至少有一个发育迟缓，很大一部分儿童在子宫内接触到 ZIKV出现轻度认知延迟和听觉行为异常。