Using oral prednisolone to treat wheezing in young children with rhinovirus
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
PHASE4 · University of Oulu · NCT05444699
This study tests if giving young children with wheezing from a rhinovirus a medication called oral prednisolone can help them breathe better.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 6 Months to 24 Months |
| Sex | All |
| Sponsor | University of Oulu (other) |
| Locations | 2 sites (Kokkola and 1 other locations) |
| Trial ID | NCT05444699 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of oral prednisolone in treating acute wheezing caused by rhinovirus in children aged 6 to 24 months. The treatment is guided by point-of-care testing to confirm the presence of rhinovirus. Participants will receive prednisolone sodium phosphate along with sugar syrup. The study aims to determine if this intervention can improve outcomes for young children experiencing wheezing bronchitis.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 24 months diagnosed with wheezing bronchitis and requiring salbutamol treatment, with confirmed rhinovirus infection.
Not a fit: Patients who may not benefit include those with serious respiratory conditions requiring immediate resuscitation or those with other viral infections not caused by rhinovirus.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective management option for young children suffering from wheezing due to rhinovirus infections.
How similar studies have performed: Other studies have explored corticosteroid use in respiratory conditions, but this specific approach using point-of-care testing for rhinovirus is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kokkola and 1 other locations
- SOITE Lastenpäivystys — Kokkola, Finland (RECRUITING)
- OYS Lastenpäivystys — Oulu, Finland (RECRUITING)
Study contacts
- Study coordinator: Ville Lindholm, MD
- Email: Ville.a.lindholm@oulu.fi
- Phone: +35883155283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bronchiolitis Acute Viral