Bronchiolitis Acute Viral
Conditions
Brief summary
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.
Interventions
Oral suspension administered 1 mg/kg once a day for three days
DRUGSugar syrup
Oral suspension administered the same amount in milliliters as experimental product once a day for three days
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* Wheezing bronchitis diagnosed by a physician * Need for salbutamol treatment at the emergency department * Positive nasopharyngeal rhinovirus or picornavirus finding in point-of-care testing
Exclusion criteria
* Need for immediate resuscitation * Immediate transfer to ICU * Suspected pneumonia based on the auscultation finding * Suspected serious bacterial infection * Other respiratory virus finding in the absence of rhinovirus or picornavirus * Positive respiratory syncytial virus finding * Positive SARS-coronavirus-2 finding * Positive Mycoplasma pneumoniae finding * Positive Bordetella pertussis finding * Contact with a person with chickenpox within 14 days * Active chickenpox * Suspected foreign body of the respiratory tract * Immunosuppressive treatment * Systemic corticosteroid treatment within 14 days * Allergy to corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Within 7 days of study entry | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total length of hospital stay | Within 7 days of study entry | The difference (in minutes) between the study entry and the actual time of discharge from the hospital |
| Intensive care unit (ICU) admissions | Within 7 days of study entry | Proportion of children admitted to ICU |
| Supplemental oxygen | Within 7 days of study entry | The total duration (in minutes) of the need for supplemental oxygen |
| Pediatric Early Warning Signs (PEWS) score | Within 7 days of study entry | 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. |
| Recurrence of wheezing | Within 56 days of study entry | Proportion of patients with recurrence of wheezing after initial episode |
| Hospital re-admission | Within 14 days of study entry | Proportion of patients with re-admission to hospital or visit to emergency department after discharge from the hospital |
| Proportion of patients with cough at 14 days of study entry | At 14 days of study entry | Proportion of patients with cough at 14 days of study entry |
| Deaths | Within 30 of study entry | Proportion of patients who died of any cause |
| Duration of salbutamol use | Within 14 days of study entry | Mean number of days in which salbutamol is used |
| Duration of respiratory distress | Within 14 days of study entry | Mean duration (in days) of respiratory distress without relapse for 3 days |
| Recurrence of wheezing (proportion) | Within 12 months of study entry | Proportion of patients with recurrence of wheezing diagnosed by a physician at 2 and 12 months of study entry |
| Recurrence of wheezing (time) | Within 12 months of study entry | Time (in days) to recurrence of wheezing diagnosed by a physician |
| Daily administrated asthma medication | Within 24 months of study entry | Time (in days) to prescription of daily administrated asthma medication |
| Antibiotics and asthma medications | Within 24 months of study entry | Purchases of antibiotics and asthma medications |
| Duration of cough | Within 28 days of study entry | Mean duration (in days) of cough without relapse for 3 days |
Countries
Finland
Contacts
Primary ContactVille Lindholm, MD
Outcome results
None listed