Hemming 1987.

Methods	Study design: parallel‐group RCT Setting: children's hospital Duration: from recruitment to discharge variable. Follow‐up 6 weeks and 1 year after discharge.
Participants	Location: USA Inclusion criteria Admitted for treatment of pneumonia or bronchiolitis Were likely to be hospitalised for more than 4 days Weighed 10 kg or less Had nasal and pharyngeal swab specimens in which RSV antigens were detected by indirect immunofluorescence Had informed consent by their parents Exclusion criteria Congenital heart disease Inability to establish an intravenous line Failure to obtain informed consent from at least 1 parent Previously known hypersensitivity to blood products Baseline characteristics (N = 35) Mean age (SD), months: treatment: 4.4 (4.3); comparator: 4.4 (4.1) Proportion male: not reported Health status/disease severity: not reported
Interventions	Treatment (N = 17): IV immunoglobulins containing high titres of RSV‐neutralising antibody (geometric mean neutralising antibody titres of approximately 1:5000) 2 g/kg body weight administered over 12 to 24 hours Comparator (N = 18): placebo 2 g/kg body weight administered over 12 to 24 hours
Outcomes	Geometric mean titres of serum RSV‐neutralising antibody and total IgG levels on day 1 following conclusion of infusion Mean daily RSV titre reduction from baseline (expressed as 50% tissue culture infective dose per 0.2 mL log10) in nasal wash specimens on day 1 to 4 following conclusion of infusion Increase or reduction from baseline in mean PO₂ oximetry values (mmHg) for study groups at day 1, 2, and 3 following conclusion of infusion Supplemental oxygen requirements during hospitalisation (no details) Duration of hospitalisation (days) Duration of clinical symptoms such as sneezing, wheezing, rhonchi, rales, retractions, nasal discharge, or nasal obstruction (days)
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	Quote: "Participants were assigned to 1 of 2 equal‐size treatment groups based on a table of random numbers." (p. 1883) Comment: there was insufficient information on the method used to generate the randomisation sequence to permit judgement.
Allocation concealment (selection bias)	Unclear risk	Comment: insufficient information on how the allocation sequence was concealed to permit judgement.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Only the study monitors (Sandoz Inc, East Hanover, NJ) knew the contents of the bottles of drug infused into each participant. The codes were not broken until the completion of each portion of the study." (p. 1883) "Lyophised human albumin, prepared in identical bottles and with protein concentrations identical to that of the IVIG, was used as the placebo drug." (p. 1882)
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: blinding of outcome assessment was not described. There is insufficient information to permit judgement of 'low risk' or 'high risk'.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Complete 2 g/kg infusions were not completed in three patients, two IVIG treated and one placebo, because of problems maintaining venous access. IgG levels rose in both of these IVIG‐treated children... suggesting receipt of most of the planned dose" (p. 1883) Comment: 35 participants were randomised. The number of participants not completing the study treatments was small (3 of 35), and analysis was based on all randomised participants for the outcomes RSV‐neutralising antibody titres, IgG levels, and nasopharyngeal RSV infectivity titres. For the outcome of oximetry, only participants completing the infusion were included in the analysis (32/35). Follow‐up was completed for 30 of the 35 children at 6 weeks and 1 year. The review authors judge that attrition is unlikely to have an important impact on the observed results.
Selective reporting (reporting bias)	Unclear risk	Comment: outcomes were not specified in the methods section. Only a description of the tests carried out during hospitalisation was provided. The reporting of outcomes does not appear to be related to whether the results were significant or not, as both were presented. Also, without a trial protocol it is unclear if other outcomes were measured but not reported based on the nature of the results.
Other bias	High risk	Quote: "This research was supported by Sandoz Pharmaceutical Corp." (p. 1885) (manufacturer of the IVIG used in this study) and the Children's Hospital National Medical Center. This may lead to bias in favour of the intervention group.