Methods |
Randomised controlled trial Study location: single centre in China Study period: March 1996 to March 1998 |
Participants |
45 preterm infants with BW ≤ 1800 grams and GA ≤ 35 weeks, age 1 day |
Interventions |
15 infants in group 1 received EPO (Kirin Brewery, Co., Ltd., Japan) 150 IU/kg (450 IU/kg/week, low dose) SC 3 times a week for 6 weeks. 15 infants in group 2 received EPO 250 IU/kg (750 IU/kg/week, high dose) SC 3 times a week for 6 weeks. 15 infants in group 3 did not receive any treatment. All infants received oral iron 20 mg (high dose) from day 7 after birth. |
Outcomes |
Use of 1 or more red blood cell transfusions Sepsis Neutropenia Hypertension Side effects |
Notes |
It is not stated whether infants who had received blood transfusions before study entry were included. It is not stated whether transfusion guidelines were in place. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Unclear |
Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment unclear |
Blinding of participants and personnel (performance bias) All outcomes |
High risk |
No placebo was given. Personnel were aware of group assignments |
Blinding of outcome assessment (detection bias) All outcomes |
High risk |
No placebo was given. Outcome assessors were aware of group assignments. |
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 |