Effectiveness of Various Environmental Measures to Eliminate the Risks of Lead Exposure in Infant Lead Poisoning
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- venous blood lead
研究概览
简要总结
Infant lead poisoning is the clinical expression of lead poisoning. This environmental disease, still present in France, is the only notifiable non-infectious disease.
Its complications include, in the foreground, disorders of psychomotor development but also include in adults the attack of other systems.
The fight against lead poisoning mainly involves the removal of lead sources. Several methods of eviction exist: a modification of the practices, a palliative rehabilitation, a definitive rehabilitation and a relocation. The effectiveness of each method is not documented. This study therefore aims to compare the effectiveness of these various measures to eliminate the risk of exposure to lead on blood lead.
This study uses the methodology of a multicenter historical cohort. It will begin in the second quarter of 2017. The research centers will be child-environment consultations and mother-child PASS in Avignon, Manosque, Marseille, Nice and Toulon.
The study will be offered to all children monitored in these centers since 2011. The inclusion criteria will include: age <18 years, at least one blood lead ≥ 50μg.L-1, residence declared in PACA and absence opposition. The retrospective data will be incorporated into the prospective monitoring. The necessary number is at least 165 cases of infantile lead poisoning (of which 33 per type of intervention). The primary endpoint will be the kinetics of quarterly venous blood lead. The smallest clinically significant difference in blood lead levels will be 50μg.L-1 between the different groups.
Statistical analysis will use intra- and inter-individual variability analysis by compartmental modeling of the pharmacokinetics of blood lead. An interim analysis will be conducted in 2017 on the retrospective data to confirm the necessary staffing.
详细描述
Infant lead poisoning is the clinical expression of lead poisoning. This environmental disease, still present in France, is the only notifiable non-infectious disease.
Its complications include, in the foreground, disorders of psychomotor development (behavioral disorders, attention, memory ...) but also include in adults the attack of other systems (kidney disorders, fertility disorders and complications). obstetric).
The fight against lead poisoning mainly involves the removal of lead sources. Several methods of eviction exist: a modification of the practices, a palliative rehabilitation, a definitive rehabilitation and a relocation. The effectiveness of each method is not documented. This study therefore aims to compare the effectiveness of these various measures to eliminate the risk of exposure to lead on blood lead.
Material and methods: This study uses the methodology of a multicenter historical cohort. It will begin in the second quarter of 2017. The research centers will be child-environment consultations and mother-child PASS in Avignon, Manosque, Marseille, Nice and Toulon.
The study will be offered to all children monitored in these centers since 2011. The inclusion criteria will include: age <18 years, at least one blood lead ≥ 50μg.L-1, residence declared in PACA and absence opposition. The retrospective data will be incorporated into the prospective monitoring. The necessary number is at least 165 cases of infantile lead poisoning (of which 33 per type of intervention). The primary endpoint will be the kinetics of quarterly venous blood lead. The smallest clinically significant difference in blood lead levels will be 50μg.L-1 between the different groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •minor (under 18 years old),
- •AND having at least one blood lead ≥ 50 μg / l between 1/11/2011 and 31/12/2022,
- •AND with at least a subsequent check of blood lead,
- •AND having been seen at least once by a Child-Environment Consultation or a mother-child PASS in PACA,
- •AND declared resident in PACA,
排除标准
- •with no blood lead ≥ 50 μg / l
- •OR adult at the time of diagnosis
- •OR opposed to participation (opposition of a parent or child served by mail)
- •OR without subsequent monitoring of blood lead,
- •OR declared resident outside Paca,
- •OR for which an environmental intervention was carried out at an unknown date
- •OR without a source of exposure found in France (eg first-time migrant child).
结局指标
主要结局
venous blood lead
时间窗: 3 years
the kinetics of venous blood lead. The monitoring rhythm is recommended every 3 months in a medical analysis laboratory. The smallest clinically significant difference will be a decrease in blood lead level of 50 μg / l.
次要结局
未报告次要终点