Soubasi 1995

Methods	Randomised controlled trial Study location: single centre, Greece Study period: not stated
Participants	97 VLBW infants with GA ≤ 31 weeks, birth weight 1500 grams or less, and age 1 to 7 days
Interventions	33 infants received rHuEPO (Cilag AG, Zug, Switzerland) 150 IU/kg twice weekly (300 IU/kg/week, low dose). 28 infants received rHuEPO 250 U/kg 3 times per week (750 IU/kg/week, high dose). EPO was administered from first week of life for 6 weeks. 36 infants (control) did not receive any treatment. All infants received oral elemental iron 3 mg/kg/d from day 15 of life (low dose). After discontinuation of EPO therapy, 75 infants were followed weekly until discharge, and thereafter at 3, 6, and 12 months of age.
Outcomes	Use of 1 or more red blood cell transfusions Number of blood transfusions per infant Mortality Follow‐up to 1 year of age Hospital stay After discontinuation of EPO therapy, 75 infants were followed weekly until discharge, and thereafter at 3, 6, and 12 months of age (no neurodevelopmental outcomes reported).
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)	Low risk	Random number table
Allocation concealment (selection bias)	Unclear risk	Infants were randomly assigned.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Control group received no placebo. Personnel were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Control group received no placebo. Outcome assessors were not blinded.
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