Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age
ConditionBronchiolitis Acute Viral
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-24
SponsorUniversity of Oulu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Need for immediate resuscitation
Immediate transfer to ICU
Suspected pneumonia based on the auscultation finding
Suspected serious bacterial infection
Trial design
Design model
Parallel
Treatments tested in this trial
Prednisolone Sodium Phosphate
DrugOral suspension administered 1 mg/kg once a day for three days
Sugar syrup
DrugOral suspension administered the same amount in milliliters as experimental product once a day for three days
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: PrednisoloneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Length 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 entrySecondary outcomes
1
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 entry2
Intensive care unit (ICU) admissions
Proportion of children admitted to ICU
Time frame
Within 7 days of study entry3
Supplemental oxygen
The total duration (in minutes) of the need for supplemental oxygen
Time frame
Within 7 days of study entry4
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 entrySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov