Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age
NCT ID: NCT05444699
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
210 participants
INTERVENTIONAL
2022-10-11
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Prednisolone
Prednisolone Sodium Phosphate (25 mg/5 mL) oral suspension administered 1 mg/kg\* (up to 20 mg = 4 mL) once a day for 3 days.
\*(0-5 kg: 5 mg; 5.01-7.5 kg: 7.5 mg; 7.51-10 kg: 10 mg; 10.01-12.5 kg: 12.5 mg; 12.51-15 kg: 15 mg; 15.01-17.5 kg: 17.5 mg; ≥ 17.51 kg: 20 mg)
Prednisolone Sodium Phosphate
Oral suspension administered 1 mg/kg once a day for three days
Placebo
Sugar syrup oral suspension containing saccharum 630-640 mg/g and aqua purificata 360-370 mg/g administered the same amount in milliliters as experimental product (up to 4 mL) once a day for 3 days.
Sugar syrup
Oral suspension administered the same amount in milliliters as experimental product once a day for three days
Interventions
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Prednisolone Sodium Phosphate
Oral suspension administered 1 mg/kg once a day for three days
Sugar syrup
Oral suspension administered the same amount in milliliters as experimental product once a day for three days
Eligibility Criteria
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Inclusion Criteria
* Need for salbutamol treatment at the emergency department
* Positive nasopharyngeal rhinovirus or picornavirus finding in point-of-care testing
Exclusion Criteria
* 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
6 Months
24 Months
ALL
No
Sponsors
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University of Oulu
OTHER
Responsible Party
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Terhi Tapiainen
Professor of Pediatrics, Head of Pediatric Infectious Diseases and Emergency Department
Locations
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SOITE Lastenpäivystys
Kokkola, , Finland
OYS Lastenpäivystys
Oulu, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-512561-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
2021-006050-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OY102021
Identifier Type: -
Identifier Source: org_study_id
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