Evaluation of Different Chemical Substances in the Milk of Breastfed Infant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Presence of contaminants (PCB, dioxins, furans and brominated flame retardants)
研究概览
简要总结
Recent international data have shown that the levels of chemical substances found in human milk could be at risk for breastfed infants. New data are necessary to assess this risk among French newborns.
详细描述
The objective of this study is to assess levels of certain contaminants in breastmilk. Measurements will be made on breastmilk samples collected in Milk Bank but not suitable for infants due to bacteriological reasons. 6 Milk Banks well distributed on the French territory will be contacted to participate. 180 women will be included. Women who gave their milk and correspond to the inclusion criteria (in particular breastfeeding a child under 6 months at the time of the donation) will be contacted by the investigator by phone. They will be asked to fill in a written consent as well as a questionnaire on socio-demographic data, pregnancy related information and potential environmental exposures.
2 breastmilk samples of 50 mL will be sendsending to the lab for analysis and 2 samples of 50 mL will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For the samples:
- •Not allowed to use for bacteriological reasons
- •Breastmilk samples from lactating women between delivery and 6 months (+/- 1 month) of the infant
- •For the mothers:
- •Age > or = 18 years
- •Lived on the French territory
- •Well french writer and speaker
- •Mother child couple in good health
- •Non opposability
排除标准
- 未提供
结局指标
主要结局
Presence of contaminants (PCB, dioxins, furans and brominated flame retardants)
时间窗: at the moment of the milk's donation
analysis of contaminants
次要结局
- evaluate the concentration of other contaminants, perfluorinated compounds, organochlorine pesticides and inorganic compounds(at the moment of the milk's donation)
- To estimate the exposure of breastfed infants and to assess the risk in this population(at the moment of the milk's donation)