TREATMENT OF LEAD EXPOSED CHILDREN FOLLOW UP

儿童铅暴露治疗(TLC)的临床试验在四个大的城市儿科进行。这项研究旨在检验一种假设，即接受琥珀酰肌醇治疗的中等血铅水平的儿童在治疗三年后，在一系列测试认知和行为发展的测试中，会比接受安慰剂治疗的儿童获得更高的分数。在1994年8月至1997年1月期间，TLC随机选择了384名儿童服用安慰剂，396名儿童服用安慰剂。认识到早期铅暴露的最重要影响在学龄前很难评估，TLC-Plus旨在评估使用琥珀酸口服螯合疗法的长期发育益处。这项研究的主要目的是确定琥珀酸是否有效地改善了早期铅中毒对神经心理功能、行为和社会适应的不利影响。一种最先进、高效的评估电池将在所有临床中心的TLC-Plus受试者七岁生日后分两次进行。在这个年龄段，可以检查更广泛和更具差异性的能力范围，心理测量测量的分数更准确和可靠，家庭环境外的早期学习成绩和社交功能可以得到评估。将对心理测量、心理教育、社会适应和神经功能进行评估。开发这些领域的仪器将在TLC受试者7岁和7.5岁时实施。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。

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.