Clinical trial NCT05444699: Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age
Official title: Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bronchiolitis Acute Viral
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 210
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: Within 7 days of study entry
Secondary outcomes:
measure: Total length of hospital stay
timeFrame: Within 7 days of study entry
measure: Intensive care unit (ICU) admissions
timeFrame: Within 7 days of study entry
measure: Supplemental oxygen
timeFrame: Within 7 days of study entry
measure: Pediatric Early Warning Signs (PEWS) score
timeFrame: Within 7 days of study entry
measure: Recurrence of wheezing
timeFrame: Within 56 days of study entry
measure: Hospital re-admission
timeFrame: Within 14 days of study entry
measure: Proportion of patients with cough at 14 days of study entry
timeFrame: At 14 days of study entry
measure: Duration of cough
timeFrame: Within 28 days of study entry
measure: Duration of cough
timeFrame: Within 14 days of study entry
measure: Duration of salbutamol use
timeFrame: Within 14 days of study entry
measure: Duration of respiratory distress
timeFrame: Within 14 days of study entry
measure: Deaths
timeFrame: Within 30 of study entry
measure: Recurrence of wheezing (proportion)
timeFrame: Within 12 months of study entry
measure: Recurrence of wheezing (time)
timeFrame: Within 12 months of study entry
measure: Daily administrated asthma medication
timeFrame: Within 24 months of study entry
measure: Antibiotics and asthma medications
timeFrame: Within 24 months of study entry
Other outcomes:
Locations:
city: Kokkola
country: Finland
facility: SOITE Lastenpäivystys
city: Oulu
country: Finland
facility: OYS Lastenpäivystys
Study officials:
References: