Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prednisolone Sodium Phosphate, Sugar syrup.
- Who it may be relevant to
- Registry conditions: Bronchiolitis Acute Viral. Basic parameters: 6 months — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Drug Prednisolone Sodium Phosphate
Oral suspension administered 1 mg/kg once a day for three days - Drug Sugar syrup
Oral suspension administered the same amount in milliliters as experimental product once a day for three days
Primary outcome measures
- Length of hospital stay [Time frame: Within 7 days of study entry]
Secondary outcome measures (12)
- Total length of hospital stay [Time frame: Within 7 days of study entry]
- Intensive care unit (ICU) admissions [Time frame: Within 7 days of study entry]
- Supplemental oxygen [Time frame: Within 7 days of study entry]
- Pediatric Early Warning Signs (PEWS) score [Time frame: Within 7 days of study entry]
- Recurrence of wheezing [Time frame: Within 56 days of study entry]
- Hospital re-admission [Time frame: Within 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 [Time frame: Within 28 days of study entry]
- Duration of cough [Time frame: Within 14 days of study entry]
- Duration of salbutamol use [Time frame: Within 14 days of study entry]
- Duration of respiratory distress [Time frame: Within 14 days of study entry]
- Deaths [Time frame: Within 30 of study entry]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Finland · 2 centers
- SOITE Lastenpäivystys — Kokkola
- OYS Lastenpäivystys — Oulu
Identifiers
NCT: NCT05444699 · OY102021 · 2024-512561-13-00 · 2021-006050-31