The aim of the prospective cohort study is to: (1) document the magnitude of response to oral corticosteroids administered to children presenting to the emergency department with moderate or severe asthma and (2) quantify clinically available potential determinants of the response to corticosteroids, such as age, gender, triggers of the index exacerbation, environmental tobacco smoke (ETS), gene polymorphisms, and their interactions.
The objective of the large multicentre cohort study is to quantify the response to oral corticosteroids in children aged 1 to 17 years presenting to the ED with a moderate or severe asthma exacerbation. The main outcome is hospital admission within 72 hours of the oral corticosteroid administration. Secondary outcomes include the change in Pediatric Respiratory Assessment Measure (PRAM), length of active treatment and other markers of response to therapy in the ED as well as markers of recovery over the next 10 days.
Study Type
OBSERVATIONAL
Enrollment
1,011
Children's Hospital of London Health Sciences Centre
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Montreal Children's Hospital (MCH)
Montreal, Quebec, Canada
CHU Sainte-Justine (CHUSJ)
Montreal, Quebec, Canada
Hospital admission
Hospital admission or Length of active treatment for 8 or more hours after the oral corticosteroid administration or ED return visit associated with hospital admission within 72 hours after the oral corticosteroid administration or ED return visit associated within 72 hours with length of active treatment for 8 or more hours after the oral corticosteroid administration
Time frame: 72 hours after oral corticosteroids administration
Length of active treatment in hospital
Time frame: 8 hours after oral corticosteroid administration
Meeting the severity criteria for admission
Proportion of children with a PRAM score ≥4 within 4 hours of oral corticosteroid administration
Time frame: Within 4 hours of oral corticosteroid administration
PRAM profile in the ED
Area under the curve of the PRAM measured hourly for the time of oral corticosteroid (OCS) until 4 hours after OCS
Time frame: Within 4 hours of oral corticosteroid administration
Time to meeting discharge criteria
Time until PRAM score ≤ 3
Time frame: Within 8 hours of oral corticosteroid administration
Change in respiratory resistance
Change in respiratory resistance between baseline and disposition will be documented on the MasterScreen Impulse Oscillometry (Cardinal Health Canada, Montreal, Canada) using previously described standardized techniques in cooperative children aged ≥3 years. (measured in a subset of individuals)
Time frame: Within 4 hours of oral corticosteroid administration
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Centre Hospitaliser de l'Université Laval
Québec, Quebec, Canada
Unscheduled visits for asthma
unscheduled visits for asthma as reported by parents and confirmed by medical charts.
Time frame: Within 7 days of the index ED exacerbation
Symptom score
Area under the curve of symptoms measured daily on the validated Asthma flare-up diary for children
Time frame: Within 7 days of the index ED exacerbation
Duration of asthma symptoms
Duration of symptoms measured daily on the validated Asthma flare-up diary for children
Time frame: Within 7 days of the index ED exacerbation
Cumulative reliever use
Cumulative number of puffs of reliever medication as recorded daily on the Asthma flare-up diary for children
Time frame: Within 7 days of the index ED exacerbation
Duration of use of rescue ß2-agonists
Duration of use of rescue ß2-agonists as recorded on the Asthma flare-up diary for children
Time frame: Within 7 days of the index ED exacerbation