Goebel 2000.

Methods	Parallel design, 2‐arm Multi‐centre (2), conducted in the US (University of South Alabama)
Participants	Outpatients (paediatric emergency department/children's clinic) Inclusion/exclusion criteria Inclusion criteria: age 23 months of age or younger; viral respiratory tract infection; 1st time wheeze that did not clear completely after 1 dose of nebulised albuterol Exclusion criteria: history of immune defect; neurological disease with possible aspiration; gastroesophageal reflux; congenital or acquired chronic heart or lung disease; mechanical ventilation; birth < 36 weeks; temp > 38.5°C (rectal); antibiotic therapy < 1 week or antipyretic therapy < 8 hours before enrolment; concomitant bacterial infection; emesis precluding oral medications; initial bronchiolitis score < 2 or > 9 Participant characteristics All groups Sample size: randomised (N): 51, analysed ‐ primary trial outcome (N): 32 (per protocol analysis was used), analysed ‐ review primary outcome (N): 48 (per protocol analysis was used) GROUP 1 Sample size: randomised (N): NR, analysed ‐ primary trial outcome (N): 17, analysed ‐ review primary outcome (N): 24 Age: 4.0 (median); 0 to 13 (range) months Males, N (%): 6 (25) RSV status: 11 positive GROUP 2 Sample size: randomised (N): NR, analysed ‐ primary trial outcome (N): 15, analysed ‐ review primary outcome (N): 24 Age: 4.5 (median); 0 to 16 (range) Males, N (%): 8 (33.3) RSV status: 15 positive Atopic status: NR
Interventions	GROUP 1 (with glucocorticoid) Drug name: prednisolone Dose: 2 mg/kg/day Mode of administration: oral Timing/duration: twice per day for 5 days GROUP 2 Drug name: placebo ‐ similar in appearance and taste, 100 mL each of water and glycerin with 5 mL of cherry‐flavoured Kool‐Aid and 100 mg of quinine Dose: equal volume per body weight Mode of administration: oral Timing/duration: twice per day for 5 days Additional co‐interventions for all groups: albuterol initially 1 dose (0.15 mg/kg), continued at 0.3 mg/kg/d 3 times a day by mouth or 0.15 mg/kg/dose qid by nebuliser Protocolised use of bronchodilators with glucocorticoids: yes (salbutamol)
Outcomes	Primary outcome Clinical scale modified from Tal et al: 12‐point score, based on respiratory rate, flaring or retractions, oxygen saturation on room air, and wheezing* Outcome used to calculate sample size NR Secondary outcomes Hospital admission ‐ initial and later; adverse events *time points: days 2, 3, 6, full convalescence
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
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"computer‐generated randomization list"
Allocation concealment (selection bias)	Low risk	Treatment formulated by the hospital pharmacy; "identical medication bottles containing either prednisolone or placebo had been previously prepared and numbered consecutively according to the randomization list."
Blinding (performance bias and detection bias) Health care use ((re)admissions, LOS, return visits)	Low risk	"similar in appearance and taste"; "all study physicians, patients, and caregivers were blinded"
Blinding (performance bias and detection bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate)	Low risk	"similar in appearance and taste"; "all study physicians, patients, and caregivers were blinded"
Incomplete outcome data (attrition bias) Health care use ((re)admissions, LOS, return visits)	High risk	3 post‐randomisation exclusions from all analyses with motives reported; 16 patients with missing primary outcome data
Incomplete outcome data (attrition bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate)	High risk	3 post‐randomisation exclusions from all analyses with motives reported; 16 patients with missing primary 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