| Methods | Randomised open controlled study Study location: single‐centre study performed in Istanbul, Turkey Study period: 1993 to 2002 | |
| Participants | 292 preterm infants < 33 weeks' GA, birth weight < 1500 grams, no blood sampling > 10 mL in the first 7 days after birth, no previous blood transfusion, no IVH > grade 1, no history of hematological disease, no urinary tract infection or sepsis | |
| Interventions | 142 infants in EPO group received EPO (EPREX 2000, Santa‐Farma‐Gurel, Istanbul) 200 IU/kg SC from the seventh day of life and continued twice weekly (400 IU/kg/week, low dose) for 6 weeks. 150 infants in the control group did not receive a placebo. Both groups received iron (3 to 5 mg/kg/d orally) (high dose). | |
| Outcomes | Use of 1 or more red blood cell transfusions Mortality NEC ROP (stage not reported) BP | |
| Notes | Infants who had received red blood cell transfusion before study entry were excluded. Transfusion guidelines were in place. The iron dose varied from 3 to 5 mg/kg/d, but we included this as a high dose in our subgroup analyses. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐assisted randomisation scheme |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo used |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No placebo used |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up: yes |
| 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 |