Methods |
Randomised controlled clinical trial Study location: single centre, Thessaloniki, Greece Study period: not stated |
Participants |
36 VLBW infants with gestational age < 31 weeks and birth weight < 1300 grams with clinical stability at the time of entry |
Interventions |
18 infants in the treatment group received rHuEPO (Cilag AG, Zug, Switzerland) 200 IU/kg every alternate day (700 units/kg/week, high dose) SC. 18 infants in the control group did not receive EPO or placebo. Duration of EPO treatment is not stated. Additionally, infants received oral iron at a dose of 12 mg/kg/d (high dose) in the EPO group and 4 mg/kg/d in the control group. Both groups were supplemented with 500 mcg of oral folate every other day, 10 IU of vitamin E every day, and multivitamins, when enteral feeding reached 75% of total fluid intake, until discharge. |
Outcomes |
Use of 1 or more red blood cell transfusions Number of transfusions per infant |
Notes |
This study does not mention the exact day when treatment was started. It is not stated whether infants who had received blood transfusions before study entry were included. Transfusion guidelines were in place. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random number table |
Allocation concealment (selection bias) |
Unclear risk |
Infants were randomly assigned to receive EPO or not. |
Blinding of participants and personnel (performance bias) All outcomes |
High risk |
No placebo was administered. Personnel were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes |
High risk |
No placebo was administered. Outcome assessors were not blinded. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Completeness 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 |