Polish Mother and Child Cohort Study (REPRO_PL).Follow up of the Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 479
- 试验地点
- 2
- 主要终点
- Exposure of children to Environmental tobacco smoke(ETS)
研究概览
简要总结
The Polish Mother and Child Cohort is multicentre prospective study on different exposures.
Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-dren's health, verification of such exposures by biomarker measurements and notification of any changes in exposure levels.
The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and children's health. Specific research hypotheses refer to the role of heavy metals, exposure to polycyclic aromatic hydrocar-bons (PAHs) and environmental tobacco smoke (ETS) in the aetiology of intrauterine growth retardation (IUGR), preterm delivery (PD) and the risk of respiratory diseases, allergy and poor mental and physical development. It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women. The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data.
The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and children's health.
This protocol concerns the children that are followed-up from birth to the age of 2 years to determine long term effects of pre- and postnatal environmental exposures.
详细描述
The Polish Mother and Child Cohort is multicentre prospective study on different exposures.
Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-dren's health, verification of such exposures by biomarker measurements and notification of any changes in exposure levels.
The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and children's health. Specific research hypotheses refer to the role of heavy metals, exposure to polycyclic aromatic hydrocar-bons (PAHs) and environmental tobacco smoke (ETS) in the aetiology of intrauterine growth retardation (IUGR), preterm delivery (PD) and the risk of respiratory diseases, allergy and poor mental and physical development. It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women. The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data.
The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and children's health.
This protocol concerns the children that are followed-up from birth to the age of 2 years to deter-mine long term effects of pre- and postnatal environmental exposures.
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
- 1 Minute 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Investigators include into the study children delivered from women observed starting from between 8-12 weeks of single pregnancy, not assisted with reproductive technology, and not expected to be finished as spontaneous abor-tion. All women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study. The same refers to suspicion of serious child malformations known to exist at the inclusion into the study.
排除标准
- •Serious child malformations known to exist at the inclusion into the study.
- •Children delivered from all women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study.
结局指标
主要结局
Exposure of children to Environmental tobacco smoke(ETS)
时间窗: Change from baseline of exposure of children to environmental tobacco smoke at 12 months
Postnatal children exposure to ETS at 12, and 24 months after birth is assessed. From the children urine sample and saliva samples from mothers who will declare smoking abstinence are collected. The saliva and urine cotinine level is analysed using high performance liquid chromatography coupled with tandem mass spectrometry/positive electrospray ionization (LC-ESI+MS/MS) and isotope dilution.
次要结局
- Exposure of children to polycyclic aromatic hydrocarbons (PAH)(Change from baseline of exposure of children to polycyclic aromatic hydrocarbons at 12 months)
- Exposure to lead, cadmium, mercury in children.(Change from baseline of exposure to lead, cadmium, mercury in children at 12 months.)
- Exposure to indoor allergens, endotoxins and glucans in children.(Change from baseline of exposure to indoor allergens, endotoxins and glucans in children at 12 months.)
- Questionnaires conducted with mothers.(Change from baseline of questionnaires scores at 12 months.)
- Determination of the prevalence of the upper and lower respiratory tract infections, middle ear diseases and allergy among the child.(Change from baseline of the prevalence of infections and allergies at 12 months)
- Determination of the neurodevelopment of the children.(Change from baseline of the neurodevelopment of the children at 12 months)
研究者
Iwona Stelmach
MD, PhD, Prof.
Medical University of Lodz