Consequences of SARS-CoV2 Pandemic on Childhood Asthma Control and Exacerbations: French Multicenter Cross-sectional VIRASTHMA COVID G4 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 577
- 试验地点
- 2
- 主要终点
- Controlled asthma
研究概览
简要总结
The SARS-CoV2 pandemic, which emerged in the first quarter of 2020, has led to an unprecedented health crisis in our modern healthcare systems and has resulted in strong national public health measures. The impact of the pandemic and its indirect environmental consequences on pediatric asthma is currently being assessed. In particular, the study of its role on the risk of exacerbations and modification of control is one of the priority research objectives defined by European societies.
The primary aim is to study the impact of the pandemic on asthma control in children aged 3-16 years with a medical diagnosis of asthma, compared to data from other observational cohorts conducted in the same region prior to the pandemic.
A sub-population of children 3-16 years will be assessed at exacerbation and at a follow-up visit, 2-4 months later, with clinical data, biological and microbiological samples.
详细描述
Children aged 3-16 years with a medical diagnosis of asthma, will be assessed for asthma control, exacerbation rate.
Data will be compared to data from other observational cohorts conducted in the same region prior to the pandemic.
A sub-population of children 3-16 years will be assessed at exacerbation and at a follow-up visit, 2-4 months later, with clinical data, biological and microbiological samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 3 to 16 years old
- •With a medical diagnosis of asthma as per-guidelines, who had been followed-up for at least 6 months,
- •Assessed in one of the pediatric departments participating in the study,
- •After written consent of at least one of the 2 parents and/or representative of the parental authority, and of the child if he is older than 8 years old.
- •Criteria for the sub-population assessed at "exacerbation" and second visit:
- •Children and adolescents aged 3 to 16 years
- •With a medical diagnosis of asthma as per-guidelines, who had been followed-up for at least 6 months,
- •Hospitalized for a severe asthma exacerbation (requiring hospitalization and general corticosteroid therapy) at Lille University Hospital
- •After written consent of both parents and/or representative of the parental authority, and of the child if he is over 8 years old
排除标准
- •History of chronic respiratory disease other than asthma,
- •Inability of parents to receive informed information, inability to participate in the entire study, refusal to sign the consent form
研究组 & 干预措施
Group 2
population included in the previous studies "VIRASTHMA", "CHAMPIASTHMA" (IRDCB No.: 2019-A03310-57), "COBRAPED" (NCT02114034), "VIRASTHMA 2" (IRDCB No.: 2014 A01687 40, NCT: 03960359), "INCOVPED" (pediatric emergencies, NCT04336761).
Group 1
population included in the VIRASTHMA COVID G4 study
结局指标
主要结局
Controlled asthma
时间窗: at inclusion
Composite criteria defined by a cACT (4-11 years) or ACT (12-16 years) score ≥ 20 and according to GINA criteria.
次要结局
- Characteristics of asthma(At inclusion and follow-up visit at 2-4 months for the sub-population included at exacerbation)
- number of infectious episodes in the past year(At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation)
- Observance(At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation)
- history of SARS-Cov2 infection in the past year(At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation)
- Respiratory virus infection (SARS-CoV2 and other)(at exacerbation and at follow-up visit at 2-4 months for the sub-population included at exacerbation)
- QoL (Quality of life) in children aged 7-17 years(At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation)
- Outdoor levels of pollutants and pollens(At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation)