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. 2017 Nov 16;2017(11):CD004863. doi: 10.1002/14651858.CD004863.pub5
Methods Double‐blind randomised controlled trial Study location: 3 centres, USA Study period: not stated
Participants 28 ELBW infants with birth weight ≤ 750 grams who were 72 hours of age or younger
Interventions 15 infants received EPO (unnamed product) 200 IU/kg/d (1400 IU/kg/week, high dose) IV, for 14 consecutive days. 13 infants received placebo as an equivalent volume of diluent in similar fashion. All infants received 1 mg/kg/d iron dextran in TPN solution during the treatment period (high dose). All infants received vitamin E 25 IU/d when they tolerated 60 mL/kg/d feeds enterally.
Outcomes Total volume of blood transfused per infant Number of transfusions per infant Mortality Sepsis IVH BPD ROP Neutropenia
Notes It is not stated whether infants who had received blood transfusions before study entry were included, but numbers of transfusions from birth to day 1 are reported; thus infants who had received transfusions were included. Transfusion guidelines were in place.
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 Infants were randomly assigned in a double‐blind fashion.
Blinding of participants and personnel (performance bias) All outcomes Low risk Study is described as a double‐blind placebo‐controlled study, and a placebo was used.
Blinding of outcome assessment (detection bias) All outcomes Low risk Study is described as a double‐blind placebo‐controlled trial, and a placebo was used.
Incomplete outcome data (attrition bias) All outcomes Low risk Complete follow‐up: yes. Two infants in each group died before the 21‐day study period.
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