CRESPI - Respiratory Health of Children in Daycare

NCT04170881 | Active Not Recruiting DMC

• 1 other identifier: C 18-05
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Health

Keywords

cleaning products; respiratory health; young children; nursery workers; nursery environment

Outcome Measures

Primary Outcomes (2)

• Current wheezing

  '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

  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)

Secondary Outcomes (1)

• Current cough

  at inclusion (2019-2021)

Study Arms (2)

CHILDREN

Children from involved daycares (Paris region)

Other: Exposed/non exposed - Epidemiology

WORKERS

workers in involved daycares (Paris region)

Other: Exposed/non exposed - Epidemiology

Interventions

Exposed/non exposed - Epidemiology OTHER

visit of daycares and environmental measurement will be performed

CHILDREN; WORKERS

Eligibility Criteria

• Age: 2 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Centre Scientifique et Technique du Bâtiment: collaborator
• EPICONCEPT: collaborator
• Ecole des Hautes Etudes en Santé Publique: collaborator
• ANSES: collaborator
• ADEME: collaborator
• National Research Agency, France: collaborator
• Agence Regionale de Sante d'Ile de France: collaborator
• Fondation de France: collaborator

Study Sites (1)

Nicole LE MOUAL

Villejuif, 94807, France

Location

Study Officials

• Nicole Le Moual, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

• Orianne Dumas, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 20, 2019
• Study Start: December 3, 2019
• Primary Completion: November 19, 2021
• Study Completion (Estimated): December 3, 2029
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)