PREDNISOLONE SODIUM PHOSPHATE for Rhinovirus-induced Wheezing

Inclusion criteria

• {"criterion_text":"- Age 6 months to 2 years\n- Acute wheezing diagnosed by an emergency department physician\n- Positive rhinovirus- or other picornavirus in nasal swap\n- Arrival at the hospital within the past 6 hours\n- Salbutamol treatment at the emergency department"}

Exclusion criteria

• {"criterion_text":"- Need for immediate resuscitation\n- Active chickenpox infection\n- Suspected foreign body in respiratory tract\n- Immunosuppressive treatment\n- Systemic glucocorticoid treatment within the previous 14 days\n- Allergy to glucocorticoids\n- Need for immediate transfer to an intensive care unit\n- Suspected pneumonia in auscultation\n- Suspected serious bacterial infection\n- Positive RS-virus in nasal swab\n- Positive SARS-CoV-2 in nasal swab\n- Positive Mycoplasma pneumoniae in nasal swab\n- Positive Bordetella pertussis in nasal swab\n- Chickenpox exposure within the previous 14 days"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Measured as the difference in minutes between study entry time and the time the patient is deemed fit for discharge (sign off for discharge)."}

Secondary endpoints

• {"endpoint_text":"- The total length of hospital stay (the difference between the study entry and the actual time of discharge from the hospital) (in minutes)\n- Intensive care unit (ICU) admission\n- The total duration of the need for supplemental oxygen (in minutes)\n- The 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.\n- The recurrence of wheezing after the initial episode within the 56 days following study enrollment\n- Hospital readmission or emergency department visit occurring within 56 days after discharge from the hospital following study enrollment\n- Cough at 14 days of study entry\n- The duration of cough (without relapse within 3 days) during the 14 days following study enrollment (in days)\n- The duration of cough (without relapse within 3 days) during the 28 days following study enrollment (in days)\n- The total number of days of salbutamol use during the 14 days following study enrollment\n- The duration of respiratory distress (without relapse within 3 days) during the 14 days following study enrollment (in days)\n- Death of any cause\n- The recurrence of wheezing diagnosed by a physician after the initial episode within two months following study enrollment\n- The recurrence of wheezing diagnosed by a physician after the initial episode within 12 months following study enrollment\n- Time to recurrence of wheezing diagnosed by a physician withing one year following study enrollment (in days)\n- Time to prescription of daily administrated asthma medication within two years following study enrollment (in days)\n- Purchases of antibiotics and asthma medications during two years following study enrollment","definition_or_measurement_approach":"Endpoints are measured as described in each line: many are time/duration measures in minutes or days (explicitly stated where applicable), categorical events (ICU admission, death), clinical scores (maximum decrease in PEWS within 12 hours), recurrence counts and healthcare utilisation over specified follow-up intervals (56 days, 14/28 days, 12 months, 2 years)."}

Finland

Earliest CTIS Part Ii Submission Date

15-03-2024

Latest Decision Or Authorization Date

10-04-2024

Processing Time Days

26

Number Of Sites

2

Number Of Participants

210

Primary sponsor

Full Name

University Of Oulu

Organisation Type

Educational Institution

Country Of Registered Address

Finland