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

基本信息

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
项目类别：
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

项目摘要

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）是黄病毒科感染的虫媒病毒（媒介传播病毒）。一直被认为是温和且具有自限性的，直到 2015 年首次观察到流行病在巴西，新生儿感染新冠病毒后出现小头畸形和其他出生缺陷母亲在怀孕期间感染了寨卡病毒 (ZIKV)，现在越来越多的证据表明 ZIKV 是一种病毒。导致母亲新生儿出现多种出生缺陷的因素妊娠期间感染 ZIKV 的关系。妊娠不良后果是迄今为止对婴儿进行的研究的主题。受感染妇女所生的孩子重点关注那些出生时患有严重先天缺陷的人，这些缺陷构成了先天性寨卡综合征（CZS）是否对生长发育有潜在影响。对于感染寨卡病毒的妇女所生的没有 CZS 的婴儿，以及这些影响可能是什么，尚不清楚，需要对感染寨卡病毒的孕妇所生的婴儿进行纵向研究。评估宫内或宫内可能表现的更广泛范围和自然史产时寨卡病毒暴露。 2016年，NIH启动了一项大型、多中心、国际观察研究婴儿和妊娠期寨卡病毒的流行病学、自然史和发病机制（ZIP ZIP 研究跟踪了有寨卡病毒感染风险的妇女所生的婴儿。仅在婴儿出生后的前 12 个月内怀孕，并在最后完成最后一名患者 2019 年 12 月访问。2018 年，NIH 启动了寨卡病毒暴露的 ZIP 2.0 队列研究儿童和 ZIP 研究或类似研究中未暴露的对照儿童，如下针对婴儿期至 42 个月大的儿童，评估寨卡病毒对儿童生长的影响和发展。最近的研究发现，在子宫内接触过寨卡病毒但未出现 CZS 的婴儿也会出现在生命的前 18 个月内有神经发育结果异常的风险 1 和同样观察到高频率的解剖学和神经发育异常一项研究发现，在子宫内接触过寨卡病毒的无小头畸形的儿童2。根据头围，发育迟缓的风险梯度，严重者小头畸形儿童延迟的风险最高，而正常头畸形的 ZIKV 暴露儿童然而，其他几项研究也显示出与未暴露的对照儿童有类似的风险。观察到患有小头畸形的儿童中神经发育异常这些报告表明，几乎所有此类儿童均在宫内暴露于 ZIKV。至少有一种发育迟缓，并且很大一部分儿童在子宫内暴露于 ZIKV 出现了轻度认知延迟和听觉行为异常。