Consequences of COVID 19 Pandemic on Childhood Asthma (NCT04821908) | Clinical Trial Compass
CompletedNot Applicable
Consequences of COVID 19 Pandemic on Childhood Asthma
France577 participantsStarted 2021-09-14
Plain-language 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.
Who can participate
Age range
3 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study looked at how the COVID-19 pandemic affected asthma control in children — do you think the findings from this research are relevant to my child's current asthma management, given everything that changed during that period?
2Since this trial has already been completed and was measuring whether children's asthma was well-controlled during the pandemic, has any published data from it changed the way you approach monitoring or adjusting asthma treatment in kids?
3The pandemic brought big changes like school closures, less outdoor time, and reduced exposure to usual triggers — do you think those kinds of environmental shifts had any lasting impact on my child's asthma patterns that we should still be accounting for today?
4Because this was an observational study rather than a treatment trial, it wouldn't have tested a new medication — so are there separate clinical trials testing actual asthma treatments in children that might be worth exploring alongside this research?
5If this study found that asthma control in children was significantly affected during the pandemic, what does that mean practically for how we set goals and measure success in managing my child's asthma now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.