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CRESPI - 日托儿童的呼吸系统健康 (CRESPI)

幼儿和日托工作者的清洁产品环境暴露和呼吸系统健康

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:

  1. 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
  2. evaluate the impact of early exposure in daycares and at home on respiratory health of young children

研究概览

地位

主动,不招人

条件

详细说明

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.

Each daycare will be visited by trained interviewers to : i) precise the objectives of the study to the parents/workers in the daycare and give all material to collect data (questionnaire, smartphone); ii) collect dust samples (to measure SVOCs; triclosan, muscs ...) via an adapted vacuum cleaner and install measuring equipment to evaluate air quality (VOCs; ammoniac, glycol ethers ...); iii) collect information on the building (surface, ventilation …) and activities of workers including a calendar of cleaning tasks in rooms (toilets, bedroom ...) and surface (toys, windows, toddler beds …).

A standardized questionnaire (http://crespi.vjf.inserm.fr/), as previously used in a parent-child cohort (sepages.inserm.fr), collecting information on the use of products, respiratory health and potential confounders will be completed by the parents. Respiratory health of the children will also be evaluated by a group of experts (paediatricians) using information available from medical records (children's health booklets).

This project will take full advantage of innovative tools, i.e. Smartphone applications, to evaluate 1) exposures : workers and parents will scan bar-codes of products used, in the nursery and at home, and respond to a short questionnaire about their use, and 2) respiratory health of children, with monthly follow-up.

Statistical analyses of the data will evaluate the associations between exposures and respiratory health of children, after adjustment for potential confounders.

研究类型

观察性的

注册 (估计的)

2000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Villejuif、法国、94807
        • Nicole LE MOUAL

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2个月 至 4年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

CRESPI is an epidemiological survey among young children - aged from 3 months to 3 years old - attending daycares and daycare workers. A random sample, drawn from a national file, of 400 nurseries in Paris region have been selected. Out of them, the 100 first daycares (30-40 children/nursery) who accepted to participated will be visit.

The CRESPI project will include detailed characterization of chemical exposures in 100 daycare centers evaluated during a one-day visit, between 2019 and 2021. We expected to enrol around 1500/2000 children and 600/800 adults workers (18-65 years old).

描述

Inclusion Criteria:

Children :

  • 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

Exclusion Criteria:

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

Children

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
CHILDREN

Children from involved daycares (Paris region)

visit of daycares and environmental measurement will be performed

WORKERS

workers in involved daycares (Paris region)

visit of daycares and environmental measurement will be performed

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Current wheezing
大体时间: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).
at inclusion (2019-2021)
Longitudinal wheezing
大体时间: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.

at inclusion (2019-2021), every month by a smartphone application (during 1 year after inclusion), every 6 months by questionnaires (2021 to 2023)

次要结果测量

结果测量
措施说明
大体时间
Current cough
大体时间:at inclusion (2019-2021)

Cough in the last 12 months defined by a standardised questionnaire will also be examined.

at inclusion (2019-2021)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Nicole Le Moual, PhD、Institut National de la Santé Et de la Recherche Médicale, France
  • 学习椅:Orianne Dumas, PhD、Institut National de la Santé Et de la Recherche Médicale, France

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年12月3日

初级完成 (实际的)

2021年11月19日

研究完成 (估计的)

2029年12月3日

研究注册日期

首次提交

2019年11月5日

首先提交符合 QC 标准的

2019年11月18日

首次发布 (实际的)

2019年11月20日

研究记录更新

最后更新发布 (实际的)

2026年10月22日

上次提交的符合 QC 标准的更新

2026年10月19日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • C 18-05

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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