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 |