CHRONIC KIDNEY DISEASE IN CHILDREN STUDY (CKID)

儿童慢性肾病研究 (CKID)

• 批准号: 7376969
• 负责人: SUSAN MENDLEY
• 金额: $ 0.2万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376969
• 关键词: CHRONIC; KIDNEY; DISEASE; CHILDREN; STUDY

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Chronic Kidney Disease in Children (CKiD) study is a prospective cohort enrolling 540 children between January 2005 and December 2006, which is sponsored by the US National Institutes of Health (i.e., NIDDK, NINDA, NICHD and NLHBI). Eligible children are aged 1 to 16 years with an estimated glomerular filtration rate (GFR) between 30 and 75 ml/min1.73m2 via the Schwartz formula at study entry; CKiD will exclude children who have had organ or stem cell transplantation; cancer/leukemia treatment, HIV treatment, or pregnancy within the past year; dialysis within the past 3 months; or a previous diagnosis of structural heart disease or a genetic syndrome involving the central nervous system (e.g., Downs syndrome). Annual study visits consist of physician examination, collection of blood and urine samples, and questionnaires eliciting information on quality of life, demographics, and medical and family histories. At alternating annual study visits, children further undertake (a) GFR estimated by Iohexol plasma disappearance curves, echocardiogram, and 24-hour ambulatory blood pressure monitoring, or (b) neurocognitive screening and additional biological specimens to quantify growth. Primary goals are to determine (1) the risk factors for decline in renal function; (2) the incidence of, and risk factors for, impaired neurocognitive development; (3) the prevalence of risk factors for cardiovascular disease; and (4) the long-term effects of growth failure and its treatment. The primary outcome is the rate of decline in GFR; a secondary outcome is time-to-ESRD, defined by transplantation, dialysis, or a 50% decline in GFR. With a two-sided type I error rate of 5%, CKiD is designed to have 80% statistical power to detect a 1.25-fold ratio of the slope of GFR in 208 exposed children to 312 unexposed children, allowing for attrition of 10%, 5% and 5% over the first 3 years of follow up, a dependence among the repeated measurements of GFR within children, and an overall annual decline in GFR of 5 ml/min1.73m2 (study website: www.statepi.jhsph.edu).

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。儿童慢性肾脏疾病(CKiD)研究是由美国国立卫生研究院(即NIDDK、NINDA、NICHD和NLHBI)赞助的一项前瞻性队列研究，在2005年1月至2006年12月期间招募了540名儿童。符合条件的儿童年龄在1至16岁，根据Schwartz公式估计肾小球滤过率(GFR)在30至75毫升/分1.73平方米之间；CKiD将排除在过去一年内接受过器官或干细胞移植、癌症/白血病治疗、艾滋病毒治疗或怀孕、过去3个月内透析或既往诊断为结构性心脏病或涉及中枢神经系统的遗传综合征(例如唐氏综合症)的儿童。每年的研究访问包括医生检查，血液和尿液样本的收集，以及收集关于生活质量、人口统计、医疗和家族史的信息的问卷。在交替的年度研究访问中，儿童进一步进行(A)通过碘海醇血浆消失曲线、超声心动图和24小时动态血压监测估计的GFR，或(B)神经认知筛查和额外的生物样本以量化生长。主要目标是确定(1)肾功能下降的风险因素；(2)神经认知发育受损的发生率和风险因素；(3)心血管疾病风险因素的流行率；(4)生长障碍及其治疗的长期影响。主要结果是肾小球滤过率下降的速度；次要结果是终末期肾病的发生时间，由移植、透析或肾小球滤过率下降50%来定义。CKiD的双面I型错误率为5%，设计为具有80%的统计能力来检测208名接触GFR的儿童和312名未接触GFR的儿童的GFR斜率的1.25倍，考虑到在最初3年的跟踪调查中，GFR的磨损率分别为10%、5%和5%，儿童内GFR的重复测量之间存在相关性，GFR的总体年降幅为5ml/min1.73m2(研究网站：www.statepi.jhsph.edu)。