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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512561-13-00 | EU Trial (CTIS) Number | ||
| 2021-006050-31 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone Sodium Phosphate | Drug | Oral suspension administered 1 mg/kg once a day for three days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Within 7 days of study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Total length of hospital stay | The difference (in minutes) between the study entry and the actual time of discharge from the hospital | Within 7 days of study entry |
| Intensive care unit (ICU) admissions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ville Lindholm, MD | Contact | +35883155283 | Ville.a.lindholm@oulu.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOITE Lastenpäivystys | Recruiting | Kokkola | Finland |
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| ID | Term |
|---|---|
| C009022 | prednisolone phosphate |
| D066248 | High Fructose Corn Syrup |
| ID | Term |
|---|---|
| D000073417 | Dietary Sugars |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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| Sugar syrup | Drug | Oral suspension administered the same amount in milliliters as experimental product once a day for three days |
|
Proportion of children admitted to ICU
| Within 7 days of study entry |
| Supplemental oxygen | The total duration (in minutes) of the need for supplemental oxygen | 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. | Within 7 days of study entry |
| Recurrence of wheezing | Proportion of patients with recurrence of wheezing after initial episode | 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 | 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 | At 14 days of study entry |
| Duration of cough | Mean duration (in days) of cough without relapse for 3 days | Within 28 days of study entry |
| Duration of cough | Mean duration (in days) of cough without relapse for 3 days | Within 14 days of study entry |
| Duration of salbutamol use | Mean number of days in which salbutamol is used | Within 14 days of study entry |
| Duration of respiratory distress | Mean duration (in days) of respiratory distress without relapse for 3 days | Within 14 days of study entry |
| Deaths | Proportion of patients who died of any cause | 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 | Within 12 months of study entry |
| Recurrence of wheezing (time) | Time (in days) to recurrence of wheezing diagnosed by a physician | Within 12 months of study entry |
| Daily administrated asthma medication | Time (in days) to prescription of daily administrated asthma medication | Within 24 months of study entry |
| Antibiotics and asthma medications | Purchases of antibiotics and asthma medications | Within 24 months of study entry |
| OYS Lastenpäivystys | Recruiting | Oulu | 90130 | Finland |
|
| D064427 |
| Nutritive Sweeteners |
| D013549 | Sweetening Agents |
| D005421 | Flavoring Agents |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |