Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of psychoactive substances concentration in newborn's hair at 6 months
研究概览
简要总结
Hair toxicological analysis is nowadays a complementary technique to blood and urinary analyses because it allows a better detection of xenobiotics in time.
The detection of xenobiotics is expressed in hours in blood and in days in urines; it is several months in the hair. So, hair makes it possible to establish a retrospective timetable of consumption and exposure to xenobiotics.
In newborns, hair has different morphological characteristics than adults' hair. It is thinner, more porous and the development phases are not the same.
Nevertheless, it is recognized that the absorption mechanisms of xenobiotics in newborns' hair are similar to those of adults. On the other hand, some difficulties of interpretation and discernment are observed between in utero exposure and environmental exposure after birth.
It is interesting to have data to estimate the absorption of psychoactive substances in newborns' hair following an utero exposure.
The main objective of this project is to study the mechanisms of incorporation of psychoactive substances administered to the mothers during pregnancy in newborns' hair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Newborns of mothers treated with known doses of psychoactive drugs during pregnancy or exposed to cannabinoids during pregnancy
- •Full-term newborns (≥37 weeks)
- •Informed consent signed by the child's legal representatives
- •Affiliation to Social Security
排除标准
- •Newborns of mothers exposed to unknown doses of psychoactive substances (excluding cannabis) during pregnancy
- •One of the child's legal representatives hasn't signed the informed consent
- •Premature delivery <37 weeks of amenorrhea
- •Newborns who can't be followed at T 4-6 months.
研究组 & 干预措施
Newborns exposed in-utero to psychoactive substances
干预措施: Umbilical cord blood and hair collection (Procedure)
结局指标
主要结局
Change of psychoactive substances concentration in newborn's hair at 6 months
时间窗: At 6 Months
The primary outcome measure is the presence of at least one molecule from the following classes of drugs (antidepressants, opioids, cannabinoids, anti-epileptics, benzodiazepines), on at least one of the hair segments studied, at a minimum concentration corresponding to the limit of quantification of the analytical technique.
次要结局
未报告次要终点