Methods |
Randomised controlled trial Study location: single centre, Austria Study period: not stated |
Participants |
30 preterm infants with birth weight of 750 to 1499 grams and 5 to 10 days old |
Interventions |
15 infants in the EPO group received epoetin alpha (Janssen‐Cilag Pharmaceuticals, Vienna, Austria) 300 IU/kg SC 3 times a week for 4 weeks. 15 infants in the control group did not receive the drug. Oral iron administration was started with a dose of 6 mg/kg/d and was increased after 2 weeks to 8 mg/kg/d. Control group participants received iron alone. |
Outcomes |
Study gives results as cumulative volume of blood transfused per kg with first and third quartiles. |
Notes |
It is not stated whether infants who had received blood transfusions before study entry were included. Transfusion guidelines were in place. One infant in the control group was withdrawn from the study because of development of IVH grade IV. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computerised random number generator |
Allocation concealment (selection bias) |
Unclear risk |
30 preterm infants were randomly assigned. |
Blinding of participants and personnel (performance bias) All outcomes |
High risk |
Control group did not receive placebo. Personnel were aware of group assignments. |
Blinding of outcome assessment (detection bias) All outcomes |
High risk |
Control group did not receive placebo. Outcome assessors were aware of group assignments. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Complete follow‐up: yes One infant in the control group was withdrawn from the study because of development of IVH grade IV. |
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 |