TREATMENT OF LEAD EXPOSED CHILDREN FOLLOW UP

铅暴露儿童的治疗后续行动

• 批准号: 2739978
• 负责人: ROBERT L BORNSCHEIN
• 金额: $ 112.83万
• 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 2004-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2739978
• 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开展。 该研究旨在检验以下假设：在治疗三年后，在一系列测量认知和行为发展的测试中，接受琥珀酸治疗的中等血铅浓度的儿童比接受安慰剂治疗的儿童得分更高。 1994 年 8 月至 1997 年 1 月期间，TLC 将 384 名儿童随机分配给安慰剂，396 名儿童分配给琥珀酸。由于认识到早期铅暴露的最重要影响在学龄前很难评估，因此 TLC-Plus 旨在评估口服琥珀酸螯合疗法的长期发育益处。 该研究的主要目的是确定琥珀酸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利影响。 所有临床中心的 TLC-Plus 受试者在七岁生日后将分两次接受最先进、高效的评估。 在这个年龄段，可以检查更广泛和更差异化的能力，心理测量的分数更加精确和可靠，并且可以评估家庭环境之外的早期学业表现和社会功能。 将进行心理测量、心理教育、社会适应和神经功能的评估。当 TLC 受试者年满 7 岁和 7.5 岁时，将使用这些领域的仪器。 意向治疗数据分析将使用协方差分析和重复测量方法来检查治疗对这些领域的影响。