Avent 2002

Methods	Randomised open controlled study Study location: 2 centres in South Africa Study period: not stated
Participants	93 infants < 7 days of life, in room air or requiring 30% oxygen at study entry with birth weight between 900 and 1500 grams Infants were stratified by weight < 1250 grams and > 1250 grams, then were randomised to 3 treatment groups.
Interventions	32 infants (low‐dose group) received EPO (Recormon) SC, 250 IU/kg 3 times a week (high dose). 31 infants (high‐dose group) received EPO (Recormon) SC, 400 IU/kg 3 times a week (high dose). 30 infants (control group) received standard care. The endpoint of therapy was reached when the infant was discharged from the hospital. All infants received a therapeutic dose of 6 mg/kg (high dose) elemental iron orally every day; this was increased to 8 to 10 mg/kg (high‐dose iron) if hypochromic cells accounted for 20% or more. All infants subsequently received blood transfusions if they met the transfusion criteria.
Outcomes	Use of 1 or more red blood cell transfusions Total volume (mL/kg) of blood transfused per infant Number of blood transfusions per infant Mortality Sepsis Hypertension Length of hospital stay
Notes	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)	Unclear risk	No information provided
Allocation concealment (selection bias)	Unclear risk	Blinding of randomisation unclear
Blinding of participants and personnel (performance bias) All outcomes	High risk	No placebo was given to the control group. Personnel were aware of treatments.
Blinding of outcome assessment (detection bias) All outcomes	High risk	No placebo was given to the control group. Outcome assessors were aware of treatments.
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