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. 2020 Feb 11;2020(2):CD004863. doi: 10.1002/14651858.CD004863.pub6

Kremenopoulos 1997A.

Methods Randomised controlled study 
 Study location: Department of Neonatology, University of Thessaloniki, Hippokratio Hospital, Thessaloniki, Greece 
 Study period: not stated
Participants 50 neonates with BW ≤ 1500 grams, PMA ≤ 31 weeks 
 Infants who had received transfusion before enrolment were included.
Interventions EPO group received rhEPO (Cilag A.G., Zug, Switzerland) 3 × 250 U/kg/week SC (750 U/kg/week – high dose) (n = 24). Treatment was given for 6 weeks. Control group (n = 26) received no intervention.
All infants received elemental iron 3 mg/kg/d.
Treatment was initiated at 3 to 7 days – early EPO.
Outcomes Transfusions/patient 
 Patients receiving transfusions
Notes Retrospectively, infants were divided into those without complications (without or with minimal signs of respiratory distress and no signs of sepsis) and those with complications requiring mechanical ventilation (RDS and sepsis with positive blood culture) for longer than 3 days, who were characterised as having complications. Outcomes were reported separately for infants without complications (we listed those outcomes under Kremenopoulos 1997A) and for infants with complications (we listed those outcomes under Kremenopoulos 1997B). An additional group of 35 infants (Group B) were enrolled at 3 to 8 weeks and will be included in the late EPO review. No information was provided regarding transfusion guidelines for either group.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided
Allocation concealment (selection bias) Unclear risk "In group A 50 infants were randomly assigned".
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No placebo was used.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No placebo was used.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes were reported for all enrolled infants.
Selective reporting (reporting bias) Unclear risk The protocol for the study was not available to us, so we cannot judge if whether deviations from the protocol occurred.
Other bias Low risk Appears free of other bias