Disrupting Noxious Synergies of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing, Using Advanced Intelligent Multisensing and Green Interventions: an Interventional Study in a Sub-group of Schoolchildren
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Statistically significant differences in spirometric parameter, Peak Flow, between case and control groups
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Child or child's parents/guardians who:
- •Refuse to participate in the project / to give informed consent.
- •Do not want to follow the protocol procedures.
- •Do not read or/and write in French.
- •Plan a long stay outside the region that does not allow them to follow the visit plan.
- •The child is not affiliated to the French social security service
研究组 & 干预措施
Control group
Subjects who have previously declared not presenting any allergic/respiratory symptoms (healthy controls)
干预措施: Lung function tests (Other)
Case group
Subjects who have previously declared to suffer from asthma and/or allergic rhinitis and/or other allergic diseases (cases)
干预措施: Standardized questionnaires (Other)
Case group
Subjects who have previously declared to suffer from asthma and/or allergic rhinitis and/or other allergic diseases (cases)
干预措施: Lung function tests (Other)
Case group
Subjects who have previously declared to suffer from asthma and/or allergic rhinitis and/or other allergic diseases (cases)
干预措施: Prick tests (Diagnostic Test)
Case group
Subjects who have previously declared to suffer from asthma and/or allergic rhinitis and/or other allergic diseases (cases)
干预措施: Biological samples (Other)
Case group
Subjects who have previously declared to suffer from asthma and/or allergic rhinitis and/or other allergic diseases (cases)
干预措施: Portable sensors (Device)
Control group
Subjects who have previously declared not presenting any allergic/respiratory symptoms (healthy controls)
干预措施: Standardized questionnaires (Other)
Control group
Subjects who have previously declared not presenting any allergic/respiratory symptoms (healthy controls)
干预措施: Prick tests (Diagnostic Test)
Control group
Subjects who have previously declared not presenting any allergic/respiratory symptoms (healthy controls)
干预措施: Biological samples (Other)
Control group
Subjects who have previously declared not presenting any allergic/respiratory symptoms (healthy controls)
干预措施: Portable sensors (Device)
结局指标
主要结局
Statistically significant differences in spirometric parameter, Peak Flow, between case and control groups
时间窗: 10 Months
Assessment of peak expiratory flow (Peak Flow, defined as the maximum flow achieved during a forced expiration, measured in L/min) between cases and controls in relation to air and dust contaminants, as assessed in the SynAirG observational study
Statistically significant differences in FeNO measurements between case and control groups
时间窗: 10 Months
Evaluation of statistically significant differences in fractional exhaled nitric oxide (FeNO, the concentration of nitric oxide in exhaled breath, measured in parts per billion \[ppb\]) between cases and controls in relation to air and dust contaminants, as assessed in the SynAirG observational study
Evaluation of statistically significant differences in spirometric parameter, FEV, between case and control groups
时间窗: 10 months
Assessment of Forced expiratory volume in 1 second (FEV₁, defined as the volume exhaled during the first second of a forced expiration, measured in L) comparing case and control groups with respect to air and dust contaminants, as assessed in the SynAirG observational study
Evaluation of statistically significant differences in spirometric parameter, FVC, between case and control groups
时间窗: 10 months
Assessment of forced vital capacity (FVC, defined as the total volume forcibly exhaled after full inspiration, measured in L), comparing case and control groups with respect to air and dust contaminants within the SynAirG observational study
Statistically significant differences in the spirometric parameter, FEV₁/FVC ratio, between case and control groups
时间窗: 10 months
Assessment of the FEV₁/FVC ratio (the proportion of FVC exhaled in the first second, measured in %), between cases and controls in relation to air and dust contaminants, as assessed in the SynAirG observational study
Statistically significant differences in spirometric parameter, FEF, between case and control groups
时间窗: 10 months
Assessment of forced expiratory flow at 25%, 50%, and 75% of FVC (FEF₂₅, FEF₅₀, and FEF₇₅, instantaneous expiratory flow rates at the corresponding lung volumes, measured in L/s), between cases and controls in relation to air and dust contaminants, as assessed in the SynAirG observational study
Evaluation of statistically significant differences in spirometric parameter, mean forced expiratory flow, between case and control groups
时间窗: 10 months
Assessment of mean forced expiratory flow between 25% and 75% of FVC (FEF₂₅-₇₅, the average expiratory flow over the middle portion of forced expiration, measured in L/s), between cases and controls in relation to air and dust contaminants, as assessed in the SynAirG observational study
次要结局
- Disease control in asthma and allergies in relation to air and dust contaminants(10 Months)
- Statistically significant differences in biological biomarkers between case and control groups(10 Months)