TEXTO : Total EXposure To Organic Pollutants
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Feasibility recruitment
研究概览
简要总结
People are, especially in industrialized countries, exposed to a growing number of ubiquitous chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and dust dermal contact...), notably for semi-volatile organic compounds. Diet is generally sought to contribute the most to total exposure for many chemicals, the relative contribution of each pathway is nevertheless poorly described, and can be different among populations. This is in particularly the case For young children, who can be more exposed via the environment, because of frequent contact with object and dust and hand to mouth behaviors. Children are in addition considered more sensitive to chemical risk due to their maturating systems.
In this context, the objective of this project is to characterize the young children's exposure to a particular class of semi volatile organic compounds. It will encompass the relative contribution of different pathways to the external dose, and to try to match the internal and external doses with a physiologically based pharmacokinetic (PBPK) model for molecules for which it is possible.
The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated Substances (PFAS), used in numerous consumer products.
详细描述
Pilot study for testing feasibility of cross sectional integrative exposure study.
Strategy : Exposure assessment of young children to PFAS with simultaneous measurement of internal (serum) and external doses (diet, indoor environment: contamination data and human exposure factors; quantity ingested and breathed).
Expected outcomes :
Assessment of feasibility to obtain:
- original data on children's body burden
- original contamination data for food, water, air and dust ;
- Matching of these data to identify main sources and pathways of exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young children (2-6 months ; 12-18 months)
- •In outpatient pediatric or pediatric surgery ;
- •From their homes ;
- •With home located less than 30km from Rennes ;
- •Living at their home (not at childcare facility or child-minder);
- •With a scheduled blood sampling apart from this study ;
- •For child 2 - 6 months :
- •With diet exclusively based on milk (maternal exclusively or commercial exclusively)
- •In case of breastfeeding, with mother accepting milk sampling ;
- •With a free, enlightened and signed written consent from the parents.
- •Breastfeeding mother :
- •> 18 years ;
- •Exclusive breastfeeding ;
- •With a free, enlightened and signed written consent.
排除标准
- •Metabolic illness ;
- •Renal or hepatic insufficiency ;
- •Malabsorption
- •With known HIV+, HBV+, HCV+, CMV+ serology
- •Simultaneously participating to other biomedical survey
- •For breastfeeding mother :
- •Under legal protection (judicial protection, guardianship) ;
- •mixed breastfeeding ;
- •with Known HIV+, HBV+, HCV+, CMV+ serology
结局指标
主要结局
Feasibility recruitment
时间窗: 3 months
Main objective of this feasibility study is to set the scientific consortium to recruit and study 2 young children's exposures. Main judgement criteria : Effective enrolment of 2 young children during their consultation to Rennes hospital, from those having a blood sampling for medical purposes, and house survey.
次要结局
- Protocol validation(1 year)