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临床试验/NCT02785926
NCT02785926已完成不适用

Impact of Antenatal Exposure to Pesticides on Neurophysiological Functions (Sleep, Respiration) of Preterm Neonates

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2013年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
response to hypoxia test (i.e peripheral chemoreceptor activity) in exposed and no exposed premature infant

研究概览

简要总结

During pregnancy, the foetus is therefore chronically exposed to a large number of substances. A number of studies have started to emphasize the effects of this antenatal exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.). However, in addition to these morphological effects, pesticides may also induce various effects on physiological functions, as some pesticides act as inhibitors of neurotransmitters involved in many nervous system regulation pathways in man. This is particularly the case for organophosphates, which act as acetylcholinesterase inhibitors. A previous study conducted by the coordinator of the project presented here demonstrated the presence of high levels of this type of pesticide in meconium (1st stool) in neonates born in Picardy. This inhibition of the enzyme metabolizing ACh could have an impact on neurophysiological functions mediated by this neurotransmitter. Sleep or respiratory control, vital functions of the neonate particularly in preterm neonates, could therefore be affected.

The PhysioMéco project is therefore designed to study the possible links between antenatal exposure to pesticides and modifications of respiratory control allowed by peripheral chemoreceptor in preterm neonates. Antenatal exposure will be determined by pesticide assays in the meconium of neonates in combination with an exposure questionnaire to determine the sources of these pesticides. Sleep and respiratory control will be studied in these neonates nursed in incubators. Hypoxic test will be used in order to assess respiratory control involving the peripheral chemoreceptors.

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
26 Weeks 至 7 Months(Child)
性别
All
接受健康志愿者

入选标准

  • premature neonates born at after 26 week of gestational age studied after 32 weeks, mothers living in Picardy and more than 18 years

排除标准

  • neonates with neurological, respiratory and cardiac disorders or receiving treatments known to affect cardiorespiratory variables or sleep structure

结局指标

主要结局

response to hypoxia test (i.e peripheral chemoreceptor activity) in exposed and no exposed premature infant

时间窗: 10 days

次要结局

  • sleep structure with EEG(10 weeks)
  • arousal in response to hypoxic test(10 weeks)
  • apnea frequency(10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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