Infant Sleep and Exposure to Mixture of Environmental Pollutants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- total sleep time per day in infants using actimetry
研究概览
简要总结
During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child's diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.
In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant's milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation.
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant less than 6 months of age still on milk diet (total)
排除标准
- •Infants with neurological or neurobehavioral disorders
- •Families who wish to relocate within 7 days of inclusion
- •Minor parents deprived of their parental rights, not understanding French, in a state of stress, overwhelmed or vulnerable.
- •Non-affiliation to a social security system
研究组 & 干预措施
New born
干预措施: 7-day actimetry sleep recording (Device)
New born
干预措施: Determination of environmental pollutants in breast milk (Other)
New born
干预措施: Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child (Other)
New born
干预措施: Continuous recording of the child's temperature for 7 days (Other)
New born
干预措施: Use of a sleep diary for 7 days (Other)
New born
干预措施: Parental questionnaire of environmental exposure (Other)
结局指标
主要结局
total sleep time per day in infants using actimetry
时间窗: 7 days
total sleep time per day (min)) in infants using actimetry
次要结局
- concentration of chemical polluants on newborn bracelets(1 day)
- Concentration of various substances in breast milk(1 day)
- Child Temperature level (°C)(7 days)