RhinoPOCRCT: Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Under 2 Years Old

Sponsor

University of Oulu (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05444699

Collaborator

(none)

210

Enrollment

Location

Arms

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The object of the trial is to evaluate if point-of-care testing directed use of oral prednisolone is beneficial in acute wheezing induced by rhinovirus in children 6-24 months old.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Acute Viral	Drug: Prednisolone Sodium Phosphate Drug: ORA-Plus-/ORA-Sweet-mixture	Phase 4

Detailed Description

The investigators study whether children 6-24 months old who have acute rhinovirus induced wheezing presenting in pediatric tertiary care hospital benefit from oral prednisolone.

The benefit has not been shown in this age group. Previous studies have not been pathogen guided. The investigators hypothesize that wheezing induced by rhinovirus is acute asthma -like syndrome and those children benefit from the treatment. The trial includes only children with point-of-care testing diagnosed rhinovirus infection.

The study is prospective, randomized, double-blind, placebo-controlled trial. The trial plans to enroll 210 children who will be randomized with a ratio of 1:1 to be either by oral prednisolone or placebo for 3 days.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Under 2 Years Old: a Point-of-care Testing Guided Prospective, Randomized, Double-blind, Placebo-controlled Trial

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prednisolone Prednisolone Sodium Phosphate (25 mg/5 ml) 1 mg/kg (up to 20 mg = 4 ml) once a day for three days.	Drug: Prednisolone Sodium Phosphate 1 mg/kg once for three days
Placebo Comparator: Placebo ORA-Plus-/ORA-Sweet-mix 0,2 ml/kg (up to 4 ml) once a day for three days.	Drug: ORA-Plus-/ORA-Sweet-mixture 0,2 ml/kg once for three days

Arm

Intervention/Treatment

Experimental: Prednisolone

Prednisolone Sodium Phosphate (25 mg/5 ml) 1 mg/kg (up to 20 mg = 4 ml) once a day for three days.

Drug: Prednisolone Sodium Phosphate

1 mg/kg once for three days

Placebo Comparator: Placebo

ORA-Plus-/ORA-Sweet-mix 0,2 ml/kg (up to 4 ml) once a day for three days.

Drug: ORA-Plus-/ORA-Sweet-mixture

0,2 ml/kg once for three days

Outcome Measures

Primary Outcome Measures

Length of stay in hospital [7 days after the study entry]
Length of stay (in minutes) within the hospital from time study drug administered until the patient is deemed fit for discharge. Subgroup analysis 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 as diagnosed by a physician Children whose sample of rhino-/picornavirus has low (< 30) cycle threshold Children whose sample of rhino-/picornavirus has medium (30-37) cycle threshold Children whose sample of rhino-/picornavirus has high (38-40) cycle threshold

Secondary Outcome Measures

Total length of stay in hospital [7 days after the study entry]
Length of stay (in minutes) within the hospital from time study drug administered until actual discharge time.
ICU-admission rate [2 days after the study entry]
Intensive care unit (ICU) admission rate during the hospital stay immediately after the intervention.
Supplemental oxygen [7 days after the study entry]
Mean number of need for supplemental oxygen (in minutes) during the hospital stay immediately after the intervention.
Pediatric Early Warning Signs -score [1 day after the study entry]
Mean number of Pediatric Early Warning Signs -score (PEWS). Score of 0-28 depending on 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. Assessed by area under curve of all PEWS-score assessments during the hospital stay immediately after the intervention.
Recurrence of wheezing [56 days after the intervention]
Rate of patients with recurrence of wheezing during 2 months after the intervention. Assessed by review of parent completed 14-day patient symptom diary and follow-up online questionnaire at 28 and 56 days after the intervention.
Hospital re-admission rate [14 days after the intervention]
Re-admission rate to hospital OR visit to emergency deparment after discharged from the hospital following the intervention. Assessed by review of medical records and parent completed 14-day patient symptom diary.
Rate of patients with cough at 2 weeks [14 days after the intervention]
Rate of patients with cough at 2 weeks. Assessed by review of parent completed 14-day patient symptom diary.
Duration of cough [28 days after the intervention]
Duration of coughing in average until at least 3 days symptom free during the first month after the intervention as assessed by review of parent completed 14-day patient symptom diary and follow-up online questionnaire at 28 days.
Duration of cough [14 days after the intervention]
Duration of coughing in average until at least 3 days symptom free during the first two weeks after the intervention as assessed by review of parent completed 14-day patient symptom diary.
Duration of salbutamol use [14 days after the intervention]
Number of days (in average) during which salbutamol is used during the first two weeks after the intervention. Assessed by review of medical records and parent completed 14-day patient symptom diary.
Duration of respiratory distress [14 days after the intervention]
Duration of respiratory distress in average until at least 3 days symptom free during the first two weeks after the intervention as assessed by review of parent completed 14-day patient symptom diary.
Mortality rate [30 days after the intervention]
Rate of death from any cause during the first month after the intervention.
Recurrence of wheezing [12 months after the intervention]
Rate of patients with recurrence of wheezing diagnosed by a physician during 12 months after the intervention. Assessed by review of medial records.
Days until recurrence of wheezing [12 months after the intervention]
Days until recurrence of wheezing diagnosed by a physician. Assessed by a review of medial records.
Days until daily administrated medication for asthma [24 months after the intervention]
Days until daily administrated medication for asthma (inhaled corticosteroid) prescribed as assessed by review of medical records.
Antibiotics and asthma medications [24 months after the intervention]
Purchases of antibiotics and medications for asthma