| Methods | Randomised controlled trial Study location: neonatal intensive care unit at Oulu University Hospital, Finland Study period: March 1998 to May 2000 | |
| Participants | 39 infants (BW 700 to 1500 grams, PMA ≤ 30.0 weeks) | |
| Interventions | 21 infants received EPO (EPO 250 IU/kg/d during the first 6 days of life IV for a period of 30 minutes) (total dose 1500 IU/kg/week). 18 infants received placebo (isotonic saline as placebo for a period of 30 minutes). None of the infants received iron during the first week of life. | |
| Outcomes | Iron status Postnatal morbidities and follow‐up at the age of 2 years | |
| Notes | We received additional information from Dr. Peltoniemi. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table |
| Allocation concealment (selection bias) | Low risk | Allocation was concealed, but details are not provided. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study drug and placebo were put into identical syringes. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Nurses, doctors, and study investigators were blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Outcomes during initial hospital stay reported for all randomised infants. Of 20 surviving children at 2 years of age, 19 were enrolled and 10 were evaluated on Griffiths Developmental Scale. Of 16 surviving placebo group children at 2 years of age, all were enrolled and 9 were evaluated at on Griffiths Developmental Scale. Follow‐up rates for Griffiths Developmental Scale were low (thus unclear risk). |
| Selective reporting (reporting bias) | Low risk | The protocol for the study was not available to us. The protocol was written in Finnish, and Dr. Antilla assured Dr. Peltoniemi that no deviations from the protocol occurred. |
| Other bias | Low risk | Appears free of other bias |