Methods |
Randomised controlled trial Study location: single‐centre study conducted in Krakow, Poland Study period: not stated |
Participants |
19 preterm infants with GA < 35 weeks' gestation and birth weight ≤ 1500 grams |
Interventions |
Infants in EPO group I (n = 6) received EPO (Recormon, Boehringer Mannheim) 100 IU/kg twice a week IV (200 IU/kg/week, low dose) between days 7 and 37, and infants in EPO group II (n = 6) received 400 IU/kg twice weekly (800 IU/kg/week, high dose) during the same time period. Control group (n = 7) received no treatment or placebo. Both EPO groups received 10 mg/kg/week of iron IV (high dose). Control group did not receive iron. |
Outcomes |
Total volume (mL/kg) of blood transfused between days 7 and 37 Side effects |
Notes |
Transfusion guidelines were in place. We could not ascertain whether infants who had received blood transfusions before study entry were included. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
No information provided |
Allocation concealment (selection bias) |
Unclear risk |
Randomly selected preterm infants |
Blinding of participants and personnel (performance bias) All outcomes |
High risk |
Control group received no placebo or iron. Personnel were aware of treatment groups. |
Blinding of outcome assessment (detection bias) All outcomes |
High risk |
Control group received no placebo or iron. Outcome assessors were aware of treatment groups. |
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 |