Rodriguez 1997b.

Methods	Design: multicentre, parallel‐group RCT Setting: children's and university hospitals Duration: recruitment to discharge variable. Follow‐up 8 weeks after discharge and during the following respiratory season.
Participants	Location: USA Inclusion criteria Previously healthy children ≤ 2 years of age Hospitalised for bronchiolitis or pneumonia, or both, who are positive for RSV antigen by immunofluorescence or ELISA Had acute lower respiratory symptoms less that 4 days' duration Had a respiratory score ≥ 2.5 Exclusion criteria Known or suspected cardiopulmonary disease Premature birth (< 32 weeks) Immunodeficiency disease Renal failure Previous reaction to blood products or having received blood products in the preceding 60 days Established diagnosis of reactive airways disease Apnoea without evidence of lower tract infection Inability to establish intravenous line (4 attempts maximum) Baseline characteristics (N = 101) Mean age (SE), months: treatment: 0.20 (0.03); comparator: 0.19 (0.03) Proportion male: treatment 48%; comparator 50% Health status/disease severity: children were described as "previously healthy" (p. 938). Mean (SE) Respiratory score (score ranges from 0 to 5, with higher scores indicating more severe disease): treatment: 3.69 (0.13); comparator: 3.77 (0.13). Proportion with Lower Respiratory Tract Infection Score 5 (score ranges from 0 to 5, with 5 indicating respiratory failure): treatment: 28%; comparator: 33%
Interventions	Treatment (N = 47): 30 mL/kg (1500 mg/kg) infusion of RSVIG  Comparator (N = 54): 30 mL/kg (1500 mg/kg) infusion of albumin placebo
Outcomes	Primary Duration of hospitalisation (days) Secondary Duration of stay in the ICU (days) Duration of mechanical ventilation (days) Duration of oxygen therapy (days) Use of ribavirin Supplemental oxygen Other Respiratory score (used as an inclusion criterion and to conduct stratified analyses in the study) Lower Respiratory Infection score (clinical investigator's assessment of participants) Analogue scale of disease severity (visual disease severity scoring system)
Notes	This study was supported by the manufacturer of the immunoglobulin used in the study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: the method used to generate the allocation sequence is unclear. There was insufficient information to permit judgement.
Allocation concealment (selection bias)	Unclear risk	Quote: "Bottles containing RSVIG or placebo were coded by the Massachusetts Public Health Biological Laboratories so that controls were unknown to investigators, sponsor and study participants." (p. 938) Comment: there was insufficient information to permit judgement.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "A one half percent (0.5%) solution of albumin bottled identically to the RSBIG was utilized as the placebo control solution." (p. 938) Comment: it is likely that participants and care providers were blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Bottles containing respiratory syncytial virus immunoglobulin or placebo were coded by the Massachusetts Public Health Biological Laboratories so that contents were unknown to the investigators, sponsor, and study participants. ...A 0.5% solution of albumin bottled identically to the RSVIG was used as the placebo solution... Attending physicians determined whether and when supplemental oxygen or mechanical ventilation was required. The decision for hospital discharge was also made by the attending physicians." (p. 938) Comment: it is likely that the personnel responsible for the primary and secondary outcome data were blinded. It is unclear who evaluated participants by the analogue scale, LRI, and respiratory score and if they were blinded to allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "One hundred one patients were enrolled in the trial, 47 in the RSVIG group and 54 in the placebo group. Forty‐six RSVIG (98%) and 52 placebo recipients (96%) could be evaluated. Excluded from the evaluation were 1 infant in the RSVIG group who received less than 75% of the infusion, 1 placebo recipient who had an admission respiratory score < 2.5, and 1 placebo patient on whom we were unable to start an intravenous infusion." (p. 939) Comment: the review authors judge that owing to the small number of participants not completing study treatments and excluded from the analysis, the similar numbers in each study group, and for reasons unlikely to be related to the outcomes, this is unlikely to have an important impact on the observed results.
Selective reporting (reporting bias)	Unclear risk	Comment: outcome data are reported for all outcomes specified in the methods section of the publication. However, without a trial protocol it is unclear whether other outcomes were measured but not reported based on the nature of the results.
Other bias	High risk	Quote: "This study was supported by MedImmune, Inc. and by Grant H5 MO1RR0069, General Clinical Research Centers Program National Institutes of Health (University of Colorado)." (p. 941) Comment: the study is supported in part by MedImmune, and a number of members of the RSVIG Study Group are employees of MedImmune (manufacturer of RSVIG). This may lead to bias in favour of the intervention group.