Consequences of COVID 19 Pandemic on Childhood Asthma
Consequences of SARS-CoV2 Pandemic on Childhood Asthma Control and Exacerbations: French Multicenter Cross-sectional VIRASTHMA COVID G4 Study
Sponsors |
Lead Sponsor: University Hospital, Lille |
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Source | University Hospital, Lille | ||||||||||||||
Brief Summary | 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. |
||||||||||||||
Detailed Description | 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. |
||||||||||||||
Overall Status | Not yet recruiting | ||||||||||||||
Start Date | July 2021 | ||||||||||||||
Completion Date | July 2025 | ||||||||||||||
Primary Completion Date | July 2025 | ||||||||||||||
Study Type | Observational | ||||||||||||||
Primary Outcome |
|
||||||||||||||
Secondary Outcome |
|
||||||||||||||
Enrollment | 577 | ||||||||||||||
Condition | |||||||||||||||
Eligibility |
Sampling Method: Probability Sample
Criteria:
Inclusion Criteria: - 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 Exclusion Criteria: - 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 Gender: All Minimum Age: 3 Years Maximum Age: 16 Years Healthy Volunteers: No |
||||||||||||||
Overall Official |
|
||||||||||||||
Overall Contact |
Last Name: Stéphanie Lejeune, MD Phone: 0320445962 Phone Ext.: +33 Email: [email protected] |
||||||||||||||
Verification Date |
March 2021 |
||||||||||||||
Responsible Party |
Type: Sponsor |
||||||||||||||
Keywords | |||||||||||||||
Has Expanded Access | No | ||||||||||||||
Condition Browse | |||||||||||||||
Arm Group |
Label: Group 1 Description: population included in the VIRASTHMA COVID G4 study Label: Group 2 Description: 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). |
||||||||||||||
Acronym | VIRASTHCOVID | ||||||||||||||
Study Design Info |
Observational Model: Other Time Perspective: Prospective |
Clinical Research News
- 08:24am
- Apr 14
- Apr 14
- Apr 14
- Apr 14
- Apr 14
- Apr 14
- Apr 14
- Apr 13
- Apr 13