TREATMENT OF LEAD EXPOSED CHILDREN FOLLOW UP

铅暴露儿童的治疗后续行动

• 批准号: 6178395
• 负责人: ROBERT L BORNSCHEIN
• 金额: $ 175.4万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-08-01 至 2004-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6178395
• 关键词: academic achievement; behavioral /social science research tag; chelation therapy; chemotherapy; child (0-11); child behavior; clinical research; cognition; cooperative study; cytotoxicity; human subject; human therapy evaluation; lead poisoning; longitudinal human study; neuropsychological tests; neuropsychology; psychometrics; social adjustment

The Treatment of Lead-Exposed Children (TLC) clinical trial was carried out in four large urban pediatric departments. The study was designed to test the hypothesis that children with moderate blood lead concentrations who were treated with succimer would have higher scores than placebo treated children on a range of tests measuring cognitive and behavioral development three years after treatment. TLC randomized 384 children to placebo and 396 to succimer between August 1994, and January, 1997. Recognizing that the most important effects of early lead exposure are difficult to assess prior to school age, TLC-Plus is designed to assess the long-term developmental benefits of oral chelation therapy with succimer. The study's principal aim is to determine whether succimer is effective in ameliorating the adverse impact of early lead toxicity on neuropsychological functioning behavior and social adjustment. A state of the art, efficient assessment battery will be administered to TLC-Plus subjects at all Clinical Centers in two sessions following their seventh birthday. At this age, a wider and more differentiated range of abilities can be examined, scores on psychometric measures are more precise and reliable, and early academic performance and social functioning outside of the home environment can be evaluated. Assessments of psychometric, psycho educational, social-adaptive, and neurological functioning will be made Instruments tapping these domains will be administered to TLC subjects when they attain 7 and 7.5 years of age. Intent-to-treat data analyses will examine the impact of treatment on these domains using analysis of covariance and repeated measures methods.

铅暴露儿童治疗（TLC）临床试验在四个大型城市儿科进行。 这项研究旨在验证这样一个假设，即在治疗三年后，中等血铅浓度的儿童接受琥珀酰亚胺治疗后，在一系列测量认知和行为发育的测试中，得分高于安慰剂治疗的儿童。 TLC在1994年8月至1997年1月期间将384名儿童随机分配到安慰剂组，396名儿童随机分配到琥珀酰亚胺组。 认识到早期铅暴露的最重要影响在学龄前难以评估，TLC-Plus旨在评估口服琥珀酰螯合疗法的长期发育益处。 本研究的主要目的是确定琥珀酰亚胺是否能有效改善早期铅中毒对神经心理功能、行为和社会适应的不良影响。 在所有临床中心，将在7岁生日后的两个阶段对TLC-Plus受试者进行最新技术水平的有效评估组合。 在这个年龄，可以检查更广泛和更有区别的能力，心理测量的分数更精确和可靠，早期的学习成绩和家庭环境之外的社会功能可以评估。 将对心理测量、心理教育、社会适应和神经功能进行评估。当TLC受试者达到7岁和7.5岁时，将对这些领域的工具进行管理。 意向治疗数据分析将使用协方差分析和重复测量方法检查治疗对这些领域的影响。