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

OY102021

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.

2022-10-11

2025-09-01

2027-09-01

Recruiting

Early phase I

210

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 210, 'type': 'ESTIMATED'}}

2024-01-19