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
Measure Time Frame
Controlled asthma at inclusion
Secondary Outcome
Measure Time Frame
Characteristics of asthma At inclusion and follow-up visit at 2-4 months for the sub-population included at exacerbation
Infections 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
QoL (Quality of life) 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
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
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
Last Name Role Affiliation
Stéphanie Lejeune, MD Principal Investigator University Hospital, Lille
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

Source: ClinicalTrials.gov

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