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Consequences of COVID 19 Pandemic on Childhood Asthma (VIRASTHCOVID)

U

University Hospital, Lille

Status

Enrolling

Conditions

Asthma in Children

Study type

Observational

Funder types

Other

Identifiers

NCT04821908
2020_85
2020-A03365-34 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

577 estimated patients

Sex

All

Ages

3 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

577 participants in 2 patient groups

Group 1
Description:
population included in the VIRASTHMA COVID G4 study
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).

Trial contacts and locations

1

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Central trial contact

Stéphanie Lejeune, MD

Data sourced from clinicaltrials.gov

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