A Phase 4 interventional study of Prednisolone Sodium Phosphate and Sugar syrup in Bronchiolitis Acute Viral, sponsored by University of Oulu. Recruiting at 2 sites in Finland. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by University of Oulu · Phase 4, Interventional, and Treatment
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.
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 210 is above the median of 100 across 195 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Prednisolone Sodium Phosphate
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.
Drug: Sugar syrup
Oral suspension administered 1 mg/kg once a day for three days
Oral suspension administered the same amount in milliliters as experimental product once a day for three days
Length of hospital stay
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) Subgroup analyses for the primary outcome are performed in following subgroups: * Children presenting with first episode of wheezing * Children with at least one previous episode of wheezing diagnosed by a physician * Children with a cycle threshold number of \< 30 for detected picornavirus * Children with a cycle threshold number of 30-37 for detected picornavirus * Children with a cycle threshold number of 38-40 for detected picornavirus
Time frame: Within 7 days of study entry
Total length of hospital stay
The difference (in minutes) between the study entry and the actual time of discharge from the hospital
Time frame: Within 7 days of study entry
Intensive care unit (ICU) admissions
Proportion of children admitted to ICU
Time frame: Within 7 days of study entry
Supplemental oxygen
The total duration (in minutes) of the need for supplemental oxygen
Time frame: Within 7 days of study entry
Pediatric Early Warning Signs (PEWS) score
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.
Time frame: Within 7 days of study entry
Recurrence of wheezing
Proportion of patients with recurrence of wheezing after initial episode
Time frame: Within 56 days of study entry
Hospital re-admission
Proportion of patients with re-admission to hospital or visit to emergency department after discharge from the hospital
Time frame: Within 14 days of study entry
Proportion of patients with cough at 14 days of study entry
Proportion of patients with cough at 14 days of study entry
Time frame: At 14 days of study entry
Duration of cough
Mean duration (in days) of cough without relapse for 3 days
Time frame: Within 28 days of study entry
Duration of cough
Mean duration (in days) of cough without relapse for 3 days
Time frame: Within 14 days of study entry
Duration of salbutamol use
Mean number of days in which salbutamol is used
Time frame: Within 14 days of study entry
Duration of respiratory distress
Mean duration (in days) of respiratory distress without relapse for 3 days
Time frame: Within 14 days of study entry
Deaths
Proportion of patients who died of any cause
Time frame: Within 30 of study entry
Recurrence of wheezing (proportion)
Proportion of patients with recurrence of wheezing diagnosed by a physician at 2 and 12 months of study entry
Time frame: Within 12 months of study entry
Recurrence of wheezing (time)
Time (in days) to recurrence of wheezing diagnosed by a physician
Time frame: Within 12 months of study entry
Daily administrated asthma medication
Time (in days) to prescription of daily administrated asthma medication
Time frame: Within 24 months of study entry
Antibiotics and asthma medications
Purchases of antibiotics and asthma medications
Time frame: Within 24 months of study entry
Plan to share: No
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Studies of the drug tested here: Prednisolone phosphate