The aim of the trial is to evaluate whether the use of oral prednisolone directed by point-of-care testing is useful in acute wheezing caused by rhinovirus in children aged 6-24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
210
Oral suspension administered 1 mg/kg once a day for three days
Oral suspension administered the same amount in milliliters as experimental product once a day for three days
SOITE Lastenpäivystys
Kokkola, Finland
RECRUITINGOYS Lastenpäivystys
Oulu, Finland
RECRUITINGLength of hospital stay
The difference (in minutes) between the study entry and the time that the patient is deemed to be fit for discharge (sign off for discharge) Subgroup analyses for the primary outcome are performed in following subgroups: * Children presenting with first episode of wheezing * Children with at least one previous episode of wheezing diagnosed by a physician * Children with a cycle threshold number of \< 30 for detected picornavirus * Children with a cycle threshold number of 30-37 for detected picornavirus * Children with a cycle threshold number of 38-40 for detected picornavirus
Time frame: Within 7 days of study entry
Total length of hospital stay
The difference (in minutes) between the study entry and the actual time of discharge from the hospital
Time frame: Within 7 days of study entry
Intensive care unit (ICU) admissions
Proportion of children admitted to ICU
Time frame: Within 7 days of study entry
Supplemental oxygen
The total duration (in minutes) of the need for supplemental oxygen
Time frame: Within 7 days of study entry
Pediatric Early Warning Signs (PEWS) score
Maximum decrease in PEWS score within 12 hours after study entry. PEWS scores range from 0 to 32 depending on the child's respiratory rate, work of breathing, saturation of peripheral oxygen, need for supplemental oxygen, blood pressure, heart rate, capillary refill and level of consciousness. 0 refers to low and \> 7 to high risk of deterioration.
Time frame: Within 7 days of study entry
Recurrence of wheezing
Proportion of patients with recurrence of wheezing after initial episode
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Time frame: Within 56 days of study entry
Hospital re-admission
Proportion of patients with re-admission to hospital or visit to emergency department after discharge from the hospital
Time frame: Within 14 days of study entry
Proportion of patients with cough at 14 days of study entry
Proportion of patients with cough at 14 days of study entry
Time frame: At 14 days of study entry
Duration of cough
Mean duration (in days) of cough without relapse for 3 days
Time frame: Within 28 days of study entry
Duration of cough
Mean duration (in days) of cough without relapse for 3 days
Time frame: Within 14 days of study entry
Duration of salbutamol use
Mean number of days in which salbutamol is used
Time frame: Within 14 days of study entry
Duration of respiratory distress
Mean duration (in days) of respiratory distress without relapse for 3 days
Time frame: Within 14 days of study entry
Deaths
Proportion of patients who died of any cause
Time frame: Within 30 of study entry
Recurrence of wheezing (proportion)
Proportion of patients with recurrence of wheezing diagnosed by a physician at 2 and 12 months of study entry
Time frame: Within 12 months of study entry
Recurrence of wheezing (time)
Time (in days) to recurrence of wheezing diagnosed by a physician
Time frame: Within 12 months of study entry
Daily administrated asthma medication
Time (in days) to prescription of daily administrated asthma medication
Time frame: Within 24 months of study entry
Antibiotics and asthma medications
Purchases of antibiotics and asthma medications
Time frame: Within 24 months of study entry