CHRONIC KIDNEY DISEASE IN CHILDREN STUDY (CKID)

儿童慢性肾病研究 (CKID)

• 批准号: 7951151
• 负责人: SUSAN MENDLEY
• 金额: $ 0.26万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951151
• 关键词: Ambulatory Blood Pressure Monitoring; Biological; Blood; Cardiovascular Diseases; Child; Chronic Kidney Failure; Clinical Research; Collection; Computer Retrieval of Information on Scientific Projects Database; Dependence; Development; Diagnosis; Dialysis procedure; Down Syndrome; Echocardiography; Enrollment; Failure; Family history of; Funding; Genetic; Glomerular Filtration Rate; Goals; Grant; Growth; HIV; Heart Diseases; Hour; Incidence; Institution; Iohexol; Long-Term Effects; Malignant Neoplasms; Measurement; National Institute of Child Health and Human Development; National Institute of Diabetes and Digestive and Kidney Diseases; Neuraxis; Neurocognitive; Organ; Physicians; Plasma; Pregnancy; Prevalence; Quality of life; Questionnaires; Renal function; Research; Research Personnel; Resources; Risk Factors; Sampling; Screening procedure; Side; Source; Specimen; Stem cell transplant; Syndrome; Time; Transplantation; United States National Institutes of Health; Urine; Visit; aged; cohort; demographics; design; follow-up; leukemia; primary outcome; prospective; secondary outcome; web site

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/min|1.73m2 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/min|1.73m2 (study website: www.statepi.jhsph.edu).

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 儿童慢性肾脏病 (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，该研究由美国国立卫生研究院（即 NIDDK、NINDA、NICHD 和 NLHBI）资助。符合条件的儿童年龄为 1 至 16 岁，在研究开始时根据 Schwartz 公式估计肾小球滤过率 (GFR) 在 30 至 75 ml/min|1.73m2 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、艾滋病毒治疗或怀孕；过去3个月内进行过透析；或先前诊断出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）。年度研究访问包括医生检查、血液和尿液样本的采集以及问卷调查，以获取有关生活质量、人口统计以及医疗和家族史的信息。在每年交替的研究访问中，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) 神经认知筛查和其他生物样本以量化生长。主要目标是确定 (1) 肾功能下降的危险因素； (2) 神经认知发育受损的发生率和危险因素； (3)心血管疾病危险因素的流行情况； (4)生长障碍及其治疗的长期影响。主要结果是 GFR 下降率；次要结局是到达 ESRD 的时间，定义为移植、透析或 GFR 下降 50%。 CKiD 的双边 I 型错误率为 5%，设计为具有 80% 的统计功效，可检测 208 名暴露儿童与 312 名未暴露儿童的 GFR 斜率的 1.25 倍之比，允许前 3 年随访期间有 10%、5% 和 5% 的流失，儿童体内 GFR 重复测量之间存在依赖性，GFR 每年总体下降 5毫升/分钟|1.73m2（研究 网站：www.statepi.jhsph.edu）。