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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 2
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Finland
SOITE Lastenpäivystys
RECRUITING
Kokkola
OYS Lastenpäivystys
RECRUITING
Oulu
Contact Information
Primary
Ville Lindholm, MD
Ville.a.lindholm@oulu.fi
+35883155283
Time Frame
Start Date: 2022-10-11
Estimated Completion Date: 2027-09
Participants
Target number of participants: 210
Treatments
Experimental: 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)
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: University of Oulu