TREATMENT OF LEAD IN CHILDREN

铅暴露儿童的治疗研究是一项多中心、随机、 安慰剂对照的双盲铅螯合试验 基线血铅为12-33个月的儿童用药琥珀酸 浓度在20至44微克/分升之间。感兴趣的主要结果是 用满分偏差智商得分来衡量发育状况 韦氏学前班和小学三年智力量表 在随机化之后。次要目标包括评价 铅螯合作用对其他发育状况指标的影响， 特别是神经心理发育测试(包括 注意力和执行功能)；身高、体重和头部的变化 周长，以及收缩和舒张压水平的变化。 此外，缺铁与中低铁之间的相互作用 目前正在调查铅中毒的程度。 这项研究涉及四个临床中心的儿童1：1随机抽样 在费城、新泽西州纽瓦克、辛辛那提和巴尔的摩。两种治疗方法 作业和主导实验室措施是双重盲目的。 印章登记工作已於一九九七年一月十七日完成。总计 260名儿童在这个地点被随机抽样。为了实现这一注册， 这项研究对大约500名儿童进行了筛查。第一个孩子 参加研究的学生达到三年，学习结束时间为 1997年8月。期末评估要到2000年1月才能完成。

The treatment of lead-exposed children study is a multicenter, randomized, placebo-controlled, double-blind clinical trial of lead chelation with the drug succimer for children 12-33 months of age with baseline blood lead concentrations between 20 and 44 ug/dl. The primary outcome of interest is developmental status as measured by full-scale deviation IQ score using the Wechsler Preschool and Primary Scales of Intelligence three years after randomization. Secondary objectives involve the evaluation of the effects of lead chelation on other measures of developmental status, particularly tests of neuro-psychological developmental (including attention and executive function); changes in height, weight and head circumference, and changes in systoic and diastolic blood pressure levels. In addition, the interactions between iron deficiency and low moderate level lead poisoning are being explored. The study involves 1:1 randomization of children at four clinical centers in Philadelphia, Newark, N.J., Cincinnati, and Baltimore. Both treatment assignments and lead laboratory measures are double-blinded. Enrollment at the CHOP site was completed on January 17, 1997. A total of 260 children were randomized at this site. To achieve this enrollment, approximately 500 children were screened for the study. The first child enrolled in the study reached the three year, end of study point in August, 1997. Final assessments will not be completed until January, 2000.