Roosevelt 1996.

Methods	Parallel design, 2 arms Single‐centre, conducted in the US (The Children's Memorial Hospital, Chicago)
Participants	Inpatients Inclusion/exclusion criteria Inclusion criteria: age < 12 months; bronchiolitis (lower respiratory tract infection characterised by wheezing); 1st episode of wheezing; requiring inpatient management; examined in ED Exclusion criteria: age: < 4 weeks old; needing admission to ICU; history of congenital heart disease; history of intubation, ventilation, or O2 therapy Participant characteristics All groups Sample size: randomised (N): 122, analysed ‐ trial primary outcomes (N): 118 (per protocol analysis was performed) GROUP 1 Sample size: randomised (N): NR, analysed ‐ trial primary outcomes (N): 65 Age, mean ± SD: 5.3 ± 3.7 months Males, N (%): 41 (63) RSV status: 39 (60) positive Atopic status: 26 (40) present (family) GROUP 2 Sample size: randomised (N): NR, analysed ‐ trial primary outcomes (N): 53 Age, mean ± SD: 5.0 ± 2.5 months Males, N (%): 33 (62) RSV status: 40 (76) positive Atopic status: 23 (43) present (family)
Interventions	GROUP 1 (with glucocorticoid) Drug name: dexamethasone Dose: 1 mg/kg Mode of administration: IM Timing/duration: every 24 hours for max 3 doses GROUP 2 Drug name: placebo (saline) Dose: equivalent volume Mode of administration: IM Timing/duration: every 24 hours for max 3 doses Additional co‐interventions for all groups: left at the discretion of physician Protocolised use of bronchodilators with glucocorticoids: no
Outcomes	Primary outcome Time to resolution (number of 12‐hour periods needed for the following criteria to be met: SaO2 > 95% while receiving no supplemental oxygen, accessory muscle score of 0, a wheeze of 0 or 1, and resumption of normal feeding) Outcomes used to calculate sample size Time to resolution; duration of O2 therapy Secondary outcomes Use of co‐interventions; clinical scale adapted from Schuh et al: 6‐point score based on accessory muscle use and wheeze*; SaO2*; respiratory rate*; heart rate*; blood pressure*; temperature*; occult blood in the stool; return healthcare visits#; hospital re‐admissions#; symptoms# *time points: every 12 hours until resolution #time points: 10 to 14 d
Funding	Green Bay Foundation ‐ James P Gorter Family Fund
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)	Unclear risk	Randomised; no further information provided
Allocation concealment (selection bias)	Low risk	"The hospital pharmacy prepared and coded drug and placebo."
Blinding (performance bias and detection bias) Health care use ((re)admissions, LOS, return visits)	Unclear risk	Double‐blind; "investigators were unaware of treatment allocation"
Blinding (performance bias and detection bias) Patient/parent‐reported outcomes (symptoms, QoL)	Unclear risk	Double‐blind; "investigators were unaware of treatment allocation"
Blinding (performance bias and detection bias) Other outcomes (adverse events, others)	Unclear risk	Double‐blind; "investigators were unaware of treatment allocation"
Incomplete outcome data (attrition bias) Health care use ((re)admissions, LOS, return visits)	Low risk	Four participant exclusions, motives reported
Incomplete outcome data (attrition bias) Patient/parent‐reported outcomes (symptoms, QoL)	High risk	Patient‐reported data missing for 29 participants, no motives reported
Incomplete outcome data (attrition bias) Other outcomes (adverse events, others)	Low risk	Four participant exclusions, motives reported
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