Trials / Active Not Recruiting
Active Not RecruitingNCT04170881
CRESPI - Respiratory Health of Children in Daycare
Daycare Environmental Exposure to Cleaning Products and Respiratory Health in Young Children and Daycare Workers
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France · Other Government
- Sex
- All
- Age
- 2 Months – 4 Years
- Healthy volunteers
- Accepted
Summary
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
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Exposed/non exposed - Epidemiology | visit of daycares and environmental measurement will be performed |
Timeline
- Start date
- 2019-12-03
- Primary completion
- 2021-11-19
- Completion
- 2029-12-03
- First posted
- 2019-11-20
- Last updated
- 2025-01-23
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04170881. Inclusion in this directory is not an endorsement.