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CRESPI - Respiratory Health of Children in Daycare (CRESPI)

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ClinicalTrials.gov Identifier: NCT04170881
Recruitment Status : Not yet recruiting
First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborators:
Centre Scientifique et Technique du Bâtiment
EPICONCEPT
Ecole des Hautes Etudes en Santé Publique
ANSES
ADEME
National Research Agency, France
Agence Regionale de Sante d'Ile de France
Fondation de France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief 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

Condition or disease Intervention/treatment
Respiratory Health Other: Exposed/non exposed - Epidemiology

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Daycare Environmental Exposure to Cleaning Products and Respiratory Health in Young Children and Daycare Workers
Estimated Study Start Date : November 19, 2019
Estimated Primary Completion Date : November 19, 2021
Estimated Study Completion Date : December 31, 2023

Group/Cohort Intervention/treatment
CHILDREN
Children from involved daycares (Paris region)
Other: Exposed/non exposed - Epidemiology
visit of daycares and environmental measurement will be performed

WORKERS
workers in involved daycares (Paris region)
Other: Exposed/non exposed - Epidemiology
visit of daycares and environmental measurement will be performed




Primary Outcome Measures :
  1. Current wheezing [ Time Frame: 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).

  2. Longitudinal wheezing [ Time Frame: 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.


Secondary Outcome Measures :
  1. Current cough [ Time Frame: at inclusion (2019-2021) ]
    Cough in the last 12 months defined by a standardised questionnaire will also be examined.



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Ages Eligible for Study:   2 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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).

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04170881


Contacts
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Contact: Nicole Le Moual, PhD 33 1 45 59 50 70 nicole.lemoual@inserm.fr
Contact: Carole Pierrart carole.pierrart@inserm.fr

Locations
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France
Nicole LE MOUAL
Villejuif, France, 94807
Contact: Nicole LE MOUAL    0145595070    nicole.lemoual@inserm.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Centre Scientifique et Technique du Bâtiment
EPICONCEPT
Ecole des Hautes Etudes en Santé Publique
ANSES
ADEME
National Research Agency, France
Agence Regionale de Sante d'Ile de France
Fondation de France
Investigators
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Principal Investigator: Nicole Le Moual, PhD Institut National de la Santé Et de la Recherche Médicale, France
Study Chair: Orianne Dumas, PhD Institut National de la Santé Et de la Recherche Médicale, France

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04170881    
Other Study ID Numbers: C 18-05
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
cleaning products
respiratory health
young children
nursery workers
nursery environment