| Methods | Randomised controlled trial Study location: Newborn Services at Ghaem Medical Center, Tehran, Iran Study period: 6 months from May 2003 | |
| Participants | Population: 40 preterm infants with BW > 1000 grams but < 1750 grams and GA > 28 weeks but < 34 weeks, who were between 48 and 96 hours old at the time of study entry | |
| Interventions | EPO group received 500 IU/kg/d of EPO SC twice weekly (1000 IU/kg/week, high dose) and iron (ferrous sulphate) 3 mg/kg/d enterally (low dose). Control infants received iron (ferrous sulphate) 3 mg/kg/d enterally (low dose) at second week of life. Parenteral iron was not administered throughout the study. | |
| Outcomes | Number of red blood cell transfusions per patient Weight gain Hospital stay | |
| Notes | "Guidelines for red‐cell transfusions were based on the relatively strict existing policy in the nursery which was used to administer transfusions during the study period". | |
| 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 | Numbered sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo was used. Personnel were aware of group assignments. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No placebo was used. Outcome assessors were aware of group assignments. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up: yes. 18 infants were excluded owing to parents' refusal and unavailability. |
| 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 |