COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)

COVID-19 补充资料 - 儿童和成人创新试验中心 (TRIDENT)

• 批准号: 10159377
• 负责人: DANIEL K. BENJAMIN
• 金额: $ 86.91万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10159377
• 关键词: 2019-nCoV; Address; Administrative Supplement; Adult; Affect; Age-Months; Award; COVID-19; COVID-19 pandemic; Child; Clinical Data; Clinical Research; Clinical and Translational Science Awards; Data; Data Pooling; Data Set; Emergency Situation; Enrollment; Epidemiology; Exposure to; Family; Frequencies; Health Personnel; Household; Immune response; Individual; Infant; Infection; Infrastructure; Knowledge; Medical; Metadata; Monitor; Mothers; Natural History; Neonatal Intensive Care Units; Observational Study; Outcome; Positioning Attribute; Pregnant Women; Public Health; Registries; Research; Research Design; Research Institute; Safety; Site; United States; Universities; Virus; Virus Shedding; clinical data warehouse; coronavirus disease; data curation; data harmonization; electronic data; improved; infant outcome; infection rate; innovation; pandemic disease; programs; response; transmission process

PROJECT SUMMARY/ABSTRACT The impact of the current COVID-19 global pandemic is likely underestimated. The specific impact on pregnant women, their infants and children is even less well characterized. We will use the infrastructure of the Duke / Vanderbilt Trial Innovation Center to address these knowledge gaps with three projects. We will use an existing electronic data warehouse of clinical data from approximately 100,000 infants admitted to over 200 neonatal intensive care units in the US to examine the epidemiology and outcomes through 12 months of age for infants born to mothers during the current pandemic. Our collaborative research team, comprising neonatologists and biostatisticians from the Duke Clinical Research Institute (DCRI) and the Pediatrix Medical Group, is uniquely positioned to complete this project. In addition, we will perform a direct-to-family observational study to evaluate the natural history of SARS-CoV-2 infection in children exposed to the virus presumably via health care worker household contact. Up to 1000 children will be enrolled across the United States. We will identify households using existing registries/trials and will evaluate the rate of infection, viral shedding, and immune response of children exposed to SARS-CoV-2. Finally, to realize the full value of the data collected as part of the multiple ongoing COVID-19 studies, data needs to be curated and harmonized. Here, data curation is defined as a metadata management activity that results in data with well-defined outcomes and exposures. The majority of curation will occur at individual study level. After the data have been harmonized, we will perform detailed quality checks. The resulting harmonized data will made availabel at different timepoints to various audiences with the final result beign a publically available de-identitified dataset. As a result of this research, we will fill major knowledge gaps related to COVID-19 and improve public health.

项目摘要/摘要 当前的Covid-19全球大流行的影响可能被低估了。对怀孕的具体影响 妇女，婴儿和儿童的特征甚至不那么好。我们将使用公爵的基础设施 / 范德比尔特试用创新中心通过三个项目解决这些知识差距。我们将使用 现有的电子数据仓库，来自约有100,000名婴儿的临床数据仓库 美国的新生儿重症监护病房在12个月大时检查流行病学和结果 对于当前大流行期间母亲出生的婴儿。我们的协作研究团队包括 杜克临床研究所（DCRI）和Pediatrix Medical的新生儿学家和生物统计学家 小组，在完成该项目方面具有独特的位置。此外，我们将直接直接到家庭 观察性研究以评估暴露于病毒的儿童中SARS-COV-2感染的自然史 大概是通过卫生保健工作者的家庭接触。多达1000名儿童将在整个联合会上注册 国家。我们将使用现有的注册表/试验确定家庭，并评估感染率，病毒 暴露于SARS-COV-2的儿童的脱落和免疫反应。最后，实现全部价值 作为多个正在进行的COVID-19研究的一部分收集的数据，需要策划和协调数据。 在这里，数据策展定义为一种元数据管理活动，导致数据定义明确 结果和暴露。大多数策划将发生在个别研究水平。数据之后 协调一致，我们将执行详细的质量检查。由此产生的统一数据将使您在 与最终结果的各种受众的不同时间点是公开可用的DE-IDEDIFIED数据集。 这项研究的结果是，我们将填补与Covid-19有关的主要知识空白，并改善公共卫生。