Skip to main content
. 2013 Jun 4;2013(6):CD004878. doi: 10.1002/14651858.CD004878.pub4

Berger 1998.

Methods Parallel design, 2‐arm
Single‐centre, conducted in Israel (affiliations: Shaare Zedek Medical Center, Jerusalem)
Participants Outpatients (emergency department)
Inclusion/exclusion criteria 
 Inclusion criteria: age ≤ 18 months; 1st episode of wheezing associated with low‐grade fever, rhinitis, tachypnoea and increased respiratory effort; otherwise healthy infant
 Exclusion criteria: chronic cardiopulmonary disease; asthma; proven or suspected acute bacterial infection; previous therapy with glucocorticoids; symptoms > 7d; fever > 38.5°C; severe bronchiolitis (clinical score > 7)
Participant characteristicsAll groups 
 Sample size: randomised (N): 42, analysed ‐ trial/review primary outcomes (N): 38 (per protocol analysis was used)
GROUP 1 
 Sample size: randomised (N): NR, analysed ‐ trial/review primary outcomes (N): 20
Age, mean ± SD: 5.2 ± 0.7
 Males, N (%): NR
 RSV status: 50% positive
 Atopic status: 1/20 (infant), 3/20 (family)
GROUP 2 
 Sample size: randomised (N): NR, analysed ‐ trial/review primary outcomes (N): 18
Age, mean ± SD: 4.8 ± 0.9
 Males, N (%): NR
 RSV status: 50% positive
 Atopic status: 0 (infant), 4/20 (family)
Interventions GROUP 1 (with glucocorticoid) 
 Drug name: prednisone
 Dose: 1 mg/kg
 Mode of administration: oral
 Timing/duration: twice daily, 3 days
GROUP 2 
 Drug name: placebo (NR)
 Dose: 1 mg/kg
 Mode of administration: oral
 Timing/duration: twice daily, 3 days
Additional co‐interventions for all groups: inhaled albuterol solution 0.03 mL/kg/dose (0.15 mg/kg/dose) every 4 to 6 hours; O2 and hydration as needed
 Protocolised use of bronchodilators with glucocorticoids: yes (salbutamol)
Outcomes Primary outcome 
 NR
Outcome used to calculate sample size 
 Clinical scale developed for this trial ‐ 9‐point score, based on respiratory rate, wheezing, accessory muscle use
Secondary outcomes 
 Initial hospital admission (usually within 4 h); SaO2*; respiratory rate*; well‐being#; return healthcare visits#; medications#; recurrent symptoms (by 2 years)
 *time points: baseline, 3 days
 #time points: 7 days
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) Unclear risk "Randomization was made according to a standardized statistical method"
Allocation concealment (selection bias) Low risk "Upon enrolment, each patient was randomly assigned by a research pharmacist"; "neither the investigators nor the families were aware of treatment assignments."
Blinding (performance bias and detection bias) 
 Health care use ((re)admissions, LOS, return visits) Low risk "The solutions provided by the pharmacy appeared identical, and neither the investigators nor the families were aware of treatment assignments." "The examiner was blind to what treatment the patient had received."
Blinding (performance bias and detection bias) 
 Clinical parameters (severity scales, SpO2, respiratory and heart rate) Low risk "The solutions provided by the pharmacy appeared identical, and neither the investigators nor the families were aware of treatment assignments." "The examiner was blind to what treatment the patient had received."
Blinding (performance bias and detection bias) 
 Patient/parent‐reported outcomes (symptoms, QoL) Low risk "The solutions provided by the pharmacy appeared identical, and neither the investigators nor the families were aware of treatment assignments." "The examiner was blind to what treatment the patient had received."
Incomplete outcome data (attrition bias) 
 Health care use ((re)admissions, LOS, return visits) Unclear risk Number completing treatment specified for each group; total of 4 drop‐outs, unclear what were the specific motives and to which arm they were assigned to
Incomplete outcome data (attrition bias) 
 Clinical parameters (severity scales, SpO2, respiratory and heart rate) Unclear risk Number completing treatment specified for each group; total of 4 drop‐outs, unclear what were the specific motives and to which arm they were assigned to
Incomplete outcome data (attrition bias) 
 Patient/parent‐reported outcomes (symptoms, QoL) Unclear risk Number completing treatment specified for each group; total of 4 drop‐outs, unclear what were the specific motives and to which arm they were assigned to
Selective reporting (reporting bias) Low risk Published report includes all pre‐specified and expected outcomes; the study protocol was not available
Other bias Low risk No significant baseline imbalances; no other sources of bias
Overall risk of bias Unclear risk > 1 domain as unclear risk of bias