Lagos 2009.

Methods	Study design: parallel‐group RCT Setting: hospital, not further described Duration: recruitment to discharge variable. Adverse events "monitored through study day 30". (p. 835)
Participants	Location: USA and Chile Inclusion criteria Previously healthy children aged < 2 years and a gestational age ≥ 36 weeks Hospitalised < 24 hours for RSV lower respiratory tract illness RSV detected in respiratory secretions within the previous 72 hours by direct fluorescent antibody or rapid antigen detection Exclusion criteria Children that had been treated with antiviral agents for the current RSV infection  Medically significant underlying illness Previous supplemental oxygen use or mechanical ventilation Use of palivizumab or other immunoglobulin products within the past 2 months Baseline characteristics Mean age (range), months: treatment: 7.6 (1.0 to 21.8); comparator: 7.4 (0.6 to 22.6) Proportion male: treatment 80%; comparator: 53% Health status/disease severity: children described as "previously healthy" (p. 835). Lower Respiratory Infection Score (6‐point scale ranging from 0 = no respiratory infection to 5 = requiring mechanical ventilation): treatment: 2.5; comparator: 2.5
Interventions	Treatment (N = 5): single IV infusion of motavizumab at a dose of 3 mg/kg Treatment (N = 5): single IV infusion of motavizumab at a dose of 15 mg/kg Treatment (N = 5): single IV infusion of motavizumab at a dose of 30 mg/kg Dose escalation occurred after ≥ 7 days of safety follow‐up of the previous dose group. Comparator (N = 15): single IV infusion of 0.45% NaCl, which was identical in appearance to the motavizumab
Outcomes	Duration of hospitalisation (days) Number of participants with > 1 instance of supplemental oxygen Total duration of supplemental oxygen (days) Number of participants admitted to ICU stay Total duration of ICU stay (days) Number of participants requiring mechanical ventilation Total duration of mechanical ventilation (days) Cultivatable RSV and viral RNA in nasal wash aspirates RSV antigen in nasal secretions Serum concentrations of motavizumab (µg/mL) Adverse events and serious adverse events
Notes	This study was funded 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	Quote: "Participants were randomised in 1:1 to groups..." (p. 835) Comment: insufficient information to permit judgement
Allocation concealment (selection bias)	Unclear risk	Quote: "Participants were randomised in 1:1 to groups..." (p. 835) Comment: insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "...identically appearing placebo" (p. 835) Comment: insufficient information to permit judgement
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "All virologic assays were performed blind with respect to treatment assignment" (p. 835) Comment: blinding occurred for the RSV quantification outcomes (RSV quantification by viral culture and reverse transcriptase polymerase chain reaction), but blinding was not described for clinical outcomes. The risk of bias for the clinical outcomes is unclear.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "thirty one children were randomised... Twenty‐nine patients completed the study." (p. 836) Comment: 1 participant randomised to motavizumab was discontinued at day 0 because the study drug could not be administered within the protocol‐specified time. 1 child was lost to follow‐up at day 8 after dosing but was included in the analysis, so outcomes are reported for 30 of the 31 randomised participants. The small number (N = 1) and reason for missing outcome data 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 research was funded by MedImmune" (p. 835) (manufacturer of motavizumab), and several authors were employees of MedImmune. This may lead to bias in favour of the treatment group.