Daycare Environmental Exposure to Cleaning Products and Respiratory Health in Young Children and Daycare Workers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Current wheezing
研究概览
简要总结
CRESPI - RESPIratory health of Children in daycare
The CRESPI study, will be a cohort of 1500/2000 children attending daycare in Paris region, and will be initiated in November 2019.
The aim of the project is to study the impact of environmental exposures to cleaning products and disinfectants on respiratory health of infants and toddlers (< 3 years) in daycares
Two specific aims were defined:
- evaluate environmental exposure to cleaning products by complementary and innovative tools: air quality measurements in daycares, specific standardized questionnaire, identification of compounds of the products via a database and a Smartphone application to scan bar codes and inform on product use
- evaluate the impact of early exposure in daycares and at home on respiratory health of young children
详细描述
Context
Exposure to cleaning products is an emergent risk factor for respiratory health of children. In some studies, an association has been observed between the use of these products in households and wheezing in young children (<18 months). However, the specific chemical substances associated with health hazards remain poorly known. A few studies suggested associations between some specific organic volatile compounds (aldehydes, aromatics) and asthma but only one study has been conducted in young children (<3 years). Detergents/disinfectants may contain sensitizers, irritants and endocrine disrupters. Children who attend daycares may be particularly exposed: cleaning tasks are often performed in their presence; moreover, babies and young children often put objects (eg, toys) in their mouths and might be exposed through various routes (ingestion, inhalation, skin). The importance of studying the health impact of early life environmental exposures has been emphasized, especially in the context of the Developmental Origins of Health and Diseases (DOHaD) research. However, few studies have focussed on environmental exposures in nurseries in relation to children's respiratory health.
The originality of the CRESPI cohort lies in the fact that no epidemiological survey focussed on: 1) the effect of early exposure to cleaning products in daycares on respiratory health in first years of life; 2) the use of complementary and innovative tools to improve evaluation of such exposures, via a Smartphone application and measurements of pertinent volatile (VOCs) and semi-volatile (SVOCs) organic compounds. 3) the use of complementary and innovative tools to improve evaluation of children respiratory health, via a Smartphone application
Methods
The project CRESPI (http://crespi.vjf.inserm.fr/) is to set up an epidemiological survey among young children attending daycares. A sample of 400 daycares (30-40 children/daycare) in Ile-de-France (Paris region) has been drawn from a national file. We hypothesise that the acceptance rate of daycares will be of 25% and those of parents at least of 50% (see French OQAI study 2011), with an expected population of 1500 to 2500 children.
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
- 2 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged from 2 months to 3 years (< 4 years) attending daycares in Paris region, among those which accepted to participate to the CRESPI study
- •signed and dated written informed consent form obtained from at least one parent
- •Nursery workers :
- •all those who accepted to participate
- •signed and dated written informed consent form obtained
排除标准
- •Children and workers : if it is impossible for them (parents or workers) to understand French langage and/or to follow the questionnaire of the study
- •both parents less than 18 years old
- •parents subjected to a legal protection measure or deprived of liberty by judicial or administrative decision
- •if at least two children of the same familly attended the same daycare, only the youngest one will be included. In case of twins or triplets, only one children will be chosen at random.
结局指标
主要结局
Current wheezing
时间窗: at inclusion (2019-2021)
'Current wheezing' phenotypes will be defined by questionnaires (paper, smartphone, web), based on responses to epidemiological standardized questionnaires and in accordance with definitions used in international studies: * wheezing in the last 12 months * severe wheezing in the last 12 months (defined by wheezing in the last 12 months with use of inhaled corticosteroid and/or the need for hospital-based care \[emergency department visit and/or hospitalization due to bronchiolitis wheezy bronchitis or asthma attacks\] in the last 12 months) * recurrent wheezing (at least 3 wheezing episodes in the last 12 months).
Longitudinal wheezing
时间窗: at inclusion (2019-2021), every month by a smartphone application (during 1 year after inclusion), every 6 months by questionnaires (2021 to 2023)
Longitudinal wheezing phenotypes will be defined by longitudinal latent class analysis (statistical clustering approach), making full use of data collected by questionnaire during follow-up (first monthly and then every six months), from infancy to age 4-years.
次要结局
- Current cough(at inclusion (2019-2021))