Klassen 1997.
| Methods | Parallel design, 2‐arm Single‐centre, conducted in Canada (Children's Hospital of Eastern Ontario) |
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| Participants | Inpatients (inpatient wards, paediatric tertiary hospital) Inclusion/exclusion criteria Inclusion criteria: age > 6 weeks < 15 mo.; 1st time wheeze; evidence of viral infection (rhinorrhoea/ temp > 37.5°C); admitted to inpatient ward; SaO2 < 95%; RDAI score > 6 Exclusion criteria: underlying disease that might affect cardiopulmonary status; asthma; wheezing/cough previously treated with bronchodilators; therapy with glucocorticoids within the past 2 weeks; history of adverse events with glucocorticoids Participant characteristics All groups Sample size: randomised (N): 72 (5 ineligible), analysed ‐ trial/review primary outcome (N): 67 (ITT with available case analysis was used) GROUP 1 Sample size: randomised (N): 35, analysed ‐ trial/review primary outcomes (N): 35 Age, mean: 4.68; 3.6 to 5.76 (95% CI) Males, N (%): 22 (63) RSV status: 30 (86%) positive GROUP 2 Sample size: randomised (N): 37, analysed ‐ trial/review primary trial outcome (N): 32 Age, mean: 4.68; 3.6 to 5.64 (95% CI) Males, N (%): 15 (47) RSV status: 28 (88%) positive Atopic status: NR |
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| Interventions |
GROUP 1 (with glucocorticoid)
Drug name: dexamethasone (clear 70% sucrose solution + dex sodium phosphate)
Dose: 1st: 0.5 mg/kg; 2nd and others: 0.3 mg/kg
Mode of administration: oral
Timing/duration: 3 doses max: at admission, once each of the following mornings or until discharge (if before) GROUP 2 Drug name: placebo (70% sucrose solution) Dose: NR Mode of administration: oral Timing/duration: 3 doses max: at admission, once each of the following mornings or until discharge (if before) Additional co‐interventions for all groups: salbutamol by nebulisation, 0.15 mg/kg every 4 hours for first 24 hours, O2 concentration of 35% in a plastic tent; reported use of additional bronchodilators and antibiotics Protocolised use of bronchodilators with glucocorticoids: yes (salbutamol) |
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| Outcomes |
Primary outcome/outcome used to calculate sample size
Clinical scale: RDAI, 17‐point score based on wheezing and retractions (at 24 h; other time points*) Secondary outcomes LOS; SaO2*; respiratory rate*; heart rate*; hospital readmission (1 week); return healthcare visits; adverse events, number of nebulisation; additional medications *time points: 12, 24, 36, 48, 60 hours |
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| Funding | Grant from Physicians Services Inc, Toronto, Ontario, Canada | |
| Notes | Study did not report any study‐level subgroup analyses This study contributed to the following comparisons in this review: steroid versus placebo |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated randomisation, stratified by age |
| Allocation concealment (selection bias) | Low risk | Randomisation performed by pharmacy; all packages of study medications were prepared and labelled with a study number; concealed until study complete and data analysis had begun |
| Blinding (performance bias and detection bias) Health care use ((re)admissions, LOS, return visits) | Low risk | Dexamethasone and placebo with identical appearance; research assistants, treating physicians, and parents were masked to the treatment allocation |
| Blinding (performance bias and detection bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Low risk | Dexamethasone and placebo with identical appearance; research assistants, treating physicians, and parents were masked to the treatment allocation |
| Blinding (performance bias and detection bias) Other outcomes (adverse events, others) | Low risk | Dexamethasone and placebo with identical appearance; research assistants, treating physicians, and parents were masked to the treatment allocation |
| Incomplete outcome data (attrition bias) Health care use ((re)admissions, LOS, return visits) | Low risk | 5 post‐randomisation exclusions, motives reported; 1 patient discharged with missing outcome data |
| Incomplete outcome data (attrition bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Low risk | 5 post‐randomisation exclusions, motives reported; 1 patient discharged with missing outcome data |
| Incomplete outcome data (attrition bias) Other outcomes (adverse events, others) | Low risk | 5 post‐randomisation exclusions, motives reported; 1 patient discharged with missing outcome data |
| Selective reporting (reporting bias) | Low risk | Published report includes all pre‐specified and expected outcomes; study protocol was not available |
| Other bias | Low risk | No significant baseline imbalances; no other sources of bias |
| Overall risk of bias | Low risk | All applicable domains low risk of bias |