CHRONIC KIDNEY DISEASE IN CHILDREN STUDY (CKID)

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。儿童慢性肾病（CKiD）研究是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，由美国国立卫生研究院（即，NIDDK、NINDA、NICHD和NLHBI）。符合条件的儿童年龄为1至16岁，在研究入组时通过Schwartz公式估计肾小球滤过率（GFR）在30至75 ml/min1.73m2之间; CKiD将排除接受过器官或干细胞移植的儿童;过去一年内接受过癌症/白血病治疗、HIV治疗或妊娠;过去3个月内接受过透析;或先前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，唐斯综合征）。每年的研究访问包括医生检查，血液和尿液样本的收集，以及问卷调查，以获取有关生活质量，人口统计学，病史和家族史的信息。在交替的年度研究访视中，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。主要目的是确定（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患病率;（4）生长衰竭及其治疗的长期影响。主要结局是GFR下降率;次要结局是至ESRD的时间，定义为移植、透析或GFR下降50%。在双侧I型错误率为5%的情况下，CKiD设计为具有80%的统计把握度，以检测208名暴露儿童与312名未暴露儿童的GFR斜率的1.25倍比率，允许在随访的前3年内出现10%、5%和5%的损耗，这是儿童GFR重复测量的依赖性，GFR总体年下降5 ml/min1.73m2（研究网站：www.statepi.jhsph.edu）。

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).