Zhang 2003.
| Methods | Parallel design, 2 arms Single‐centre, conducted in Brazil (teaching hospital of the Federal University of Rio Grande, Rio Grande) |
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| Participants | Inpatients (30‐bed paediatric inpatient ward) Inclusion/exclusion criteria Inclusion criteria: age < 12 months, diagnosis of bronchiolitis, 1st episode of wheezing with respiratory distress, history of upper respiratory tract infection Exclusion criteria: age < 4 weeks; any chronic cardiac or pulmonary disease; congenital abnormality; immediate favourable response to administration of single dose nebulised fenoterol; received glucocorticoids < 4 weeks; severe initial disease requiring intensive care Participant characteristics All groups Sample size: randomised (N): 52, analysed ‐ trial primary outcomes (N): 50 (ITT with available case analysis was performed), analysed ‐ review primary outcomes (N): 52 (ITT with all data was performed) GROUP 1 Sample size: randomised (N): 28, analysed ‐ trial primary outcomes (N): 26 , analysed ‐ review primary outcomes (N): 28 Age, mean ± SD: 4.0 ± 2.5 months Males, N (%): 21 (75) Atopic status: 23 (82.1) present (family) GROUP 2 Sample size: randomised (N): 24, analysed ‐ trial/review primary outcomes (N): 24 Age, mean ± SD: 3.4 ± 1.8 months Males, N (%): 20 (83.3) Atopic status: 21 (87.5) present (family) RSV status: NR |
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| Interventions |
GROUP 1 (with glucocorticoid)
Drug name: prednisolone + standard care (see below)
Dose: 1 mg/kg
Mode of administration: oral
Timing/duration: 1st at enrolment; once daily at 8:00 am for 4 days (total 5 days of treatment); if hospital stay < 5 d, remaining doses given at home GROUP 2 Drug name: standard care Dose: judged by attending physician based on standard protocol: O2 therapy, fluid replacement, nebulised fenoterol Mode of administration: NR Timing/duration: NR Additional co‐interventions for all groups: standard care as stated above; attending paediatricians were advised against prescribing any glucocorticoid for recruited patients (use of IV hydrocortisone was reported) Protocolised use of bronchodilators with glucocorticoids: no |
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| Outcomes |
Primary outcome/outcome used to calculate sample size
prevalence of post bronchiolitic wheeze (at 1, 3, 6, 12 mo) Secondary outcomes LOS; duration of O2 therapy; time to clinical resolution ‐ defined as the days needed for the following criteria to be met: pulse blood oxygen saturation above 95% without supplemental oxygen, absence of chest retractions and respiratory rate less than upper limits for age (< 2 months 60 bpm; 2 to 12 months 50 bpm) |
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| Funding | Research Support Foundation of Rio Grande do Sul | |
| 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 | "random‐number table generated randomization list" |
| Allocation concealment (selection bias) | Low risk | "The independent pharmacy staff members were responsible for group assignment and distribution of prednisolone"; "The randomization list was concealed until the study was complete." |
| Blinding (performance bias and detection bias) Health care use ((re)admissions, LOS, return visits) | High risk | Authors report that "All study investigators were blinded to treatment assignment throughout the study." However, no blinded placebo comparator is used |
| Blinding (performance bias and detection bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | High risk | Authors report that "All study investigators were blinded to treatment assignment throughout the study." However, no blinded placebo comparator is used |
| Blinding (performance bias and detection bias) Patient/parent‐reported outcomes (symptoms, QoL) | High risk | Authors report that "All study investigators were blinded to treatment assignment throughout the study." However, no blinded placebo comparator is used |
| Blinding (performance bias and detection bias) Other outcomes (adverse events, others) | High risk | Authors report that "All study investigators were blinded to treatment assignment throughout the study." However, no blinded placebo comparator is used |
| Incomplete outcome data (attrition bias) Health care use ((re)admissions, LOS, return visits) | Low risk | No missing outcome data |
| Incomplete outcome data (attrition bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Low risk | No missing outcome data |
| Incomplete outcome data (attrition bias) Patient/parent‐reported outcomes (symptoms, QoL) | Low risk | Two participants with missing long‐term symptom outcome data |
| Incomplete outcome data (attrition bias) Other outcomes (adverse events, others) | Low risk | No 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 | High risk | > 1 domain as high risk of bias |
(Support for 'Risk of bias' judgement is shown for domains with unclear risk)
bpm = beats per minute d = day ED = emergency department h = hour ICU = intensive care unit IM = intramuscular IQR = interquartile range ITT = intention‐to‐treat IV = intravenous LOS = length of stay mo = month NR = not reported qid = four times a day RDAI = Respiratory Distress Assessment Instrument RSV = respiratory syncytial virus SD = standard deviation SaO2 = oxygen saturation tx = treatment URTI = upper respiratory tract infection