| Methods | Randomised double‐blind controlled clinical trial Study location: single centre, Chile Study period: April 1998 to December 1999 | |
| Participants | 60 newborn infants under 1500 grams birth weight; mean age at entry in the EPO group 7.75 ± 2.42 days, and mean age at entry in the control group 7.96 ± 2.44 days | |
| Interventions | 29 infants in the EPO group received r‐EPO (Eritropoyetina del Laboraorio Andromaco) 200 IU/kg SC, 3 times a week (600 IU/kg/week, high dose), during 4 weeks. 31 infants in the control group received similar volume of isotonic saline solution in similar fashion. All infants received oral iron at a dose of 3 mg/kg/d (low dose). | |
| Outcomes | Number of transfusions per infant Sepsis IVH | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information presented |
| Allocation concealment (selection bias) | Unclear risk | "were randomised ina double‐blind fashion" ‐ but no specific information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No specific information provided |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No specific information provided |
| 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 |