Respiratory HealthCRESPINCT04170881
CRESPI - Respiratory Health of Children in Daycare
An observational study of Respiratory Health, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Health
- What is being tested?
- Exposed/non exposed - Epidemiology
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2019to 3 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daycare Environmental Exposure to Cleaning Products and Respiratory Health in Young Children and Daycare Workers
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.
Read more
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
Read the 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
- Respiratory Health
- Being tested
- Exposed/non exposed - Epidemiology
- Keywords
- cleaning products, respiratory health, young children, nursery workers, nursery environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposed/non exposed - EpidemiologyOther
visit of daycares and environmental measurement will be performed
| Study group | Role | What they receive |
|---|---|---|
| CHILDREN | Children from involved daycares (Paris region) Receives: Other: Exposed/non exposed - Epidemiology | |
| WORKERS | workers in involved daycares (Paris region) Receives: Other: Exposed/non exposed - Epidemiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Cough in the last 12 months defined by a standardised questionnaire will also be examined.
Measured: at inclusion (2019-2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start3 Dec 2019
- Primary completion19 Nov 2021
- Study completion3 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory HealthStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- 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
- Responsible party
- Sponsor
- Investigators
- Nicole Le Moual, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, FranceOrianne Dumas, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170881
- Sponsor's protocol ID
- C 18-05
- Acronym
- CRESPI
- Status last verified
- Sep 2026
- First submitted
- 5 Nov 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sakellaris IA, Mandin C, Bright F, Orsi L, Amat F, Bonnet P, Siroux V, Moual NL, Dumas O. Association between volatile organic compound concentrations in daycares and child wheeze: the French CRESPI study. Environ Health. 2026 May 13;25(1):58. doi: 10.1186/s12940-026-01307-6.
PubMed 42129817
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daycare Environmental Exposure to Cleaning Products and Respiratory Health in Young Children and Daycare Workers
- ClinicalTrials.gov ID
- NCT04170881
- Acronym / sponsor ID
- CRESPI / C 18-05
- Conditions
- Respiratory Health
- Keywords
- cleaning products, respiratory health, young children, nursery workers, nursery environment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- 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
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 3 Dec 2029 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHILDREN | – | Other: Exposed/non exposed - EpidemiologyChildren from involved daycares (Paris region) |
| WORKERS | – | Other: Exposed/non exposed - Epidemiologyworkers in involved daycares (Paris region) |
Who may qualify
- Ages
- 2 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (6 listed)
- 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
- all those who accepted to participate
- signed and dated written informed consent form obtained
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposed/non exposed - Epidemiologyvisit of daycares and environmental measurement will be performed | Other | CHILDREN, WORKERS |
Primary outcome
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).
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.
1 secondary outcome
Current cough
Time frame: at inclusion (2019-2021)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Results publication: PubMed 42129817Sakellaris IA, Mandin C, Bright F, Orsi L, Amat F, Bonnet P, Siroux V, Moual NL, Dumas O. Association between volatile organic compound concentrations in daycares and child wheeze: the French CRESPI study. Environ Health. 2026 May 13;25(1):58. doi: 10.1186/s12940-026-01307-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Le Moual, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Orianne Dumas, PhD study chair
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Health, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current wheezing (time frame: at inclusion (2019-2021)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04170881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.