De Boeck 1997.
| Methods | Parallel design, 2‐arm Single‐centre, conducted in Belgium (affiliation: University Hospital Leuven) |
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| Participants | Inpatients Inclusion/exclusion criteria Inclusion criteria: age < 24 months; detection of RSV; 1st episode of wheezing or shortness of breath; onset of illness within the previous 5 days; informed consent Exclusion criteria: heart, lung or immune disorder; premature infants born before 34 weeks Participant characteristics All groups Sample size: randomised (N): 32, analysed ‐ all trial outcomes (N): 29 (per protocol analysis was used) GROUP 1 Sample size: randomised (N): NR, analysed ‐ all trial outcomes (N): 14 Age: 6.2 (median), 3.7 to 7.5 (IQR) months RSV status: all positive GROUP 2 Sample size: randomised (N): NR, analysed ‐ all trial outcomes (N): 15 Age: 7.1 (median), 4.4 to 8.9 (IQR) RSV status: all positive Males, N (%): NR Atopic status: NR |
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| Interventions |
GROUP 1 (with glucocorticoid)
Drug name: dexamethasone
Dose: 0.6 mg/kg
Mode of administration: IV
Timing/duration: day 1, 2 doses of 0.6 mg/kg; days 2 and 3, 0.15 mg/kg GROUP 2 Drug name: placebo (NR) Dose: NR Mode of administration: IV Timing/duration: day 1, 2 doses of 0.6 mg/kg; days 2 and 3, 0.15 mg/kg Additional co‐interventions for all groups: salbutamol (0.5%); 0.25 mL, ipratropium bromide (0.025%), 0.5 mL; both aerosolised every 6 h; also reported use of antibiotics Protocolised use of bronchodilators with glucocorticoids: yes (salbutamol + ipratropium) |
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| Outcomes |
Primary outcome/outcome used to calculate sample size
NR Secondary outcomes LOS; SaO2*; respiratory rate*; clinical scale modified from Tal et al ‐ 12‐point score; pulmonary function tests (minute ventilation, dynamic lung compliance, and airway resistance ‐ PEDS, MAS, Inc., Hatfield, Pa.) (before/after aerosol and day 3) *time points: every 12 hours until day 3 |
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| Funding | NR | |
| 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) | Unclear risk | "patients were randomised"; no further information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) Health care use ((re)admissions, LOS, return visits) | Unclear risk | "double‐blind"; no further information provided |
| Blinding (performance bias and detection bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Unclear risk | "double‐blind"; no further information provided |
| Blinding (performance bias and detection bias) Pulmonary function | Unclear risk | "double‐blind"; no further information provided |
| Incomplete outcome data (attrition bias) Health care use ((re)admissions, LOS, return visits) | Unclear risk | 3 participants did not complete the study and were not included in the analysis; no report of motives or arm to which they had been assigned |
| Incomplete outcome data (attrition bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Unclear risk | 3 participants did not complete the study and were not included in the analysis; no report of motives and arm to which they had been assigned |
| Incomplete outcome data (attrition bias) Pulmonary function | Unclear risk | 3 participants did not complete the study and were not included in the analysis; no report of motives and arm to which they had been assigned |
| Selective reporting (reporting bias) | Unclear risk | Not all time points were reported and some outcomes with reported results were not mentioned in methods |
| Other bias | Unclear risk | Few details on baseline characteristics |
| Overall risk of bias | Unclear risk | > 1 domain as unclear risk of bias |