Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age
- Conditions
- Bronchiolitis Acute Viral
- Interventions
- Drug: Sugar syrup
- Registration Number
- NCT05444699
- Lead Sponsor
- University of Oulu
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prednisolone Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate (25 mg/5 mL) oral suspension administered 1 mg/kg\* (up to 20 mg = 4 mL) once a day for 3 days. \*(0-5 kg: 5 mg; 5.01-7.5 kg: 7.5 mg; 7.51-10 kg: 10 mg; 10.01-12.5 kg: 12.5 mg; 12.51-15 kg: 15 mg; 15.01-17.5 kg: 17.5 mg; ≥ 17.51 kg: 20 mg) Placebo Sugar syrup Sugar syrup oral suspension containing saccharum 630-640 mg/g and aqua purificata 360-370 mg/g administered the same amount in milliliters as experimental product (up to 4 mL) once a day for 3 days.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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 (time) Within 12 months of study entry Time (in days) to recurrence of wheezing diagnosed by a physician
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
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.
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
Deaths Within 30 of study entry Proportion of patients who died of any cause
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
Daily administrated asthma medication Within 24 months of study entry Time (in days) to prescription of daily administrated asthma medication
Recurrence of wheezing Within 56 days of study entry Proportion of patients with recurrence of wheezing after initial episode
Duration of cough Within 14 days of study entry Mean duration (in days) of cough without relapse for 3 days
Duration of salbutamol use Within 14 days of study entry Mean number of days in which salbutamol is used
Antibiotics and asthma medications Within 24 months of study entry Purchases of antibiotics and asthma medications
Trial Locations
- Locations (2)
SOITE Lastenpäivystys
🇫🇮Kokkola, Finland
OYS Lastenpäivystys
🇫🇮Oulu, Finland