| Methods | Double‐blind randomised controlled trial Study location: 3 centres, USA Study period: not stated | |
| Participants | 28 ELBW infants with birth weight ≤ 750 grams who were 72 hours of age or younger | |
| Interventions | 15 infants received EPO (unnamed product) 200 IU/kg/d (1400 IU/kg/week, high dose) IV, for 14 consecutive days. 13 infants received placebo as an equivalent volume of diluent in similar fashion. All infants received 1 mg/kg/d iron dextran in TPN solution during the treatment period (high dose). All infants received vitamin E 25 IU/d when they tolerated 60 mL/kg/d feeds enterally. | |
| Outcomes | Total volume of blood transfused per infant Number of transfusions per infant Mortality Sepsis IVH BPD ROP Neutropenia | |
| Notes | It is not stated whether infants who had received blood transfusions before study entry were included, but numbers of transfusions from birth to day 1 are reported; thus infants who had received transfusions were included. Transfusion guidelines were in place. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Low risk | Infants were randomly assigned in a double‐blind fashion. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study is described as a double‐blind placebo‐controlled study, and a placebo was used. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study is described as a double‐blind placebo‐controlled trial, and a placebo was used. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up: yes. Two infants in each group died before the 21‐day study period. |
| Selective reporting (reporting bias) | Unclear risk | The protocol for the study was not available to us; therefore we cannot ascertain whether deviations from the protocol occurred |
| Other bias | Low risk | Appears free of other bias |