Driva 1985.
Methods | RCT. No details of allocation process available. Nursery nurse and assessors blind to allocation | |
Participants | 40 infants with IDA (Hb < 11.0 g/dL and all suffering from iron deficiency) aged 3‐25 months recruited from an orphanage in Greece | |
Interventions | IM injection of iron 50 mg in the intervention group | |
Outcomes | Bayley Scales of infant Development administered pre and 10 days post commencement of intervention | |
Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no sufficient information provided |
Allocation concealment (selection bias) | Unclear risk | Comment: no sufficient information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote (from the report): "Neither the tester nor the nursery nurse knew the type of therapeutic intervention" Comment: Insufficient information on blinding of investigators |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (from the report): "Neither the tester nor the nursery nurse knew the type of therapeutic intervention" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome measures are available for all children. Complete follow‐up in both intervention group and control group |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |