Study of Indoor Air Pollutants and Their Impact in Children's Health and Wellbeing (SynAir-G2)

University Hospital Center (CHU)

Status: Enrolling

Conditions: Allergy

Treatments: Diagnostic Test: Prick tests; Other: Standardized questionnaires; Other: Lung function tests; Device: Portable sensors; Other: Biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT07402200

2024-A00254-43 (Registry Identifier)

RECHMPL23_0262

Details and patient eligibility

About

The goal of this study is to identify and assess in real time the impact of the combined action of various types of air and dust pollutants within a classroom on children's health and quality of life, particularly regarding atopic/allergic diseases in children, and on potential exposure to pollutants at home.

Participants will answer questionnaires regarding their health and medications, undergo allergy tests, perform non-invasive lung function tests and check blood oxygen levels.

Full description

The number and types of indoor air pollutants in schools is rising, however little is known about the impact of their potentially synergistic interactions, upon schoolchildren health. Among children, highly susceptible individuals to air pollution include allergy and asthma sufferers, and a low socioeconomic background, however no specific guidance is available.

The design of the study provides a unique setting to prospectively assess the synergistic effect of pollutants at school and outdoor on several health aspects in a large and diverse cohort. Most importantly, the continuous nature of information provided by sentinel devices will provide an individualized baseline of specific indicators that will be monitored during the follow up period, to identify personalized health alterations, instead of comparing to generalized standards. Health outcome data, including respiratory health, immune fitness and both mental and non-mental perspectives, focusing on asthmatic/allergic children, will contribute to pollution sensing in an iterative way

Enrollment: 100 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Child included in the SynAir-G observational study

• Child and caregiver(s) willing to follow the study procedures

• Written informed consent from the child's parents/guardians

• For case group, at least one positive answer (yes) to any of the following questions and for control group, negative answers to all the following questions based on the baseline questionnaire administered in the SynAir-G observational study, as shown below.:

  a. General health i. Does your child have any health problems (if yes to asthma, allergic rhinitis /rhino-conjunctivitis, atopic dermatitis)? b. Asthma i. Has your child ever had wheezing or whistling in the chest in the past 12 months? ii. In the past 12 months, has your child's chest sounded wheezy during or after exercise? iii. In the past 12 months, has your child had a dry cough at night, apart from a cough associated with a cold or chest infection? c. Rhinitis i. In the past 12 months has your child had a problem with sneezing, or a runny, or blocked nose when she/he DID NOT have a cold or the flu? d. Eczema (both answers yes) i. Has your child had this itchy rash at any time in the past 12 months? If so, has this itchy rash at any time affected any of the following places: the folds of the elbows, behind the knees, in front of the ankles, under the buttocks, or around the neck, ears or eyes? e. Food allergy i. Has your child had diagnosed food allergy during last 12 months?

• For case group: Diagnosis of asthma/allergic rhinitis/eczema/food allergy (based on SYNAIR-G baseline questionnaire), active during the past year.

• For control group: absence of diagnosis of asthma/allergic rhinitis/eczema/food allergy (based on SYNAIR-G baseline questionnaire)

Exclusion criteria

• Child or child's parents/guardians who:

  1. Refuse to participate in the project / to give informed consent.
  2. Do not want to follow the protocol procedures.
  3. Do not read or/and write in French.
  4. Plan a long stay outside the region that does not allow them to follow the visit plan.
  5. The child is not affiliated to the French social security service

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Case group

Other group

Description:

Subjects who have previously declared to suffer from asthma and/or allergic rhinitis and/or other allergic diseases (cases)

Treatment:

Device: Portable sensors

Other: Biological samples

Other: Lung function tests

Diagnostic Test: Prick tests

Other: Standardized questionnaires

Control group

Other group

Description:

Subjects who have previously declared not presenting any allergic/respiratory symptoms (healthy controls)

Treatment:

Device: Portable sensors

Other: Biological samples

Other: Lung function tests

Diagnostic Test: Prick tests

Other: Standardized questionnaires