Methods |
Randomised controlled trial Study location: Newborn Services at Ghaem Medical Center, Tehran, Iran Study period: 6 months from May 2003 |
Participants |
Population: 40 preterm infants with BW > 1000 grams but < 1750 grams and GA > 28 weeks but < 34 weeks, who were between 48 and 96 hours old at the time of study entry |
Interventions |
EPO group received 500 IU/kg/d of EPO SC twice weekly (1000 IU/kg/week, high dose) and iron (ferrous sulphate) 3 mg/kg/d enterally (low dose). Control infants received iron (ferrous sulphate) 3 mg/kg/d enterally (low dose) at second week of life. Parenteral iron was not administered throughout the study. |
Outcomes |
Number of red blood cell transfusions per patient Weight gain Hospital stay |
Notes |
"Guidelines for red‐cell transfusions were based on the relatively strict existing policy in the nursery which was used to administer transfusions during the study period". |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
No information provided |
Allocation concealment (selection bias) |
Low risk |
Numbered sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes |
High risk |
No placebo was used. Personnel were aware of group assignments. |
Blinding of outcome assessment (detection bias) All outcomes |
High risk |
No placebo was used. Outcome assessors were aware of group assignments. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Complete follow‐up: yes. 18 infants were excluded owing to parents' refusal and unavailability. |
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 |