Ohls 2001B.

Methods	Double‐blind randomised controlled trial Study location: multi‐centre trial, USA Trial period not stated The study was performed concurrently as 2 parallel trials based on birth weight, because different primary outcomes were evaluated in each trial. We report under Ohls 2001A on infants with birth weight 401 to 1000 grams, and under Ohls 2001B on infants with birth weight 1001 to 1250 grams.
Participants	118 infants with birth weight 1001 to 1250 grams, PMA ≤ 32 weeks, and between 24 and 96 hours old at the time of study entry who were likely to survive > 72 hours
Interventions	59 infants in the EPO group received 400 U/kg EPO (unnamed product) 3 times weekly (1200 IU/kg/week, high dose) IV or SC when IV access was not available. 59 infants in the placebo/control group received sham SC injections when IV access was not available. An adhesive bandage covered true and sham injection sites. Treatment was continued until discharge, transfer, death, or 35 completed weeks' corrected PMA.
Outcomes	Numer of infants who received any transfusion (primary outcome) Use of 1 or more red blood cell transfusions Mean number of erythrocyte transfusions per infant Number of donors the infant was exposed to Total volume of blood transfused per infant Late‐onset sepsis Mortality Chronic lung disease (at 36 weeks' postmenstrual age) ROP stage ≥ 3 Severe IVH (stage ≥ 3) NEC BPD Neutropenia Hypertension Hospital stay At follow‐up (see notes), growth, development, rehospitalization, transfusions
Notes	Infants in Ohls 2001B were not examined at 18 to 22 months' corrected age. Only infants in Ohls 2001A were examined at follow‐up (see notes under Ohls 2001A).
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	Blinding of randomisation: yes. All caregivers and investigators (except research nurses) were masked to treatment assignment.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	All caregivers and investigators (except research nurses) were masked to treatment assignment.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All caregivers and investigators (except research nurses) were masked to treatment assignment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All infants were followed through their hospital stay up to 120 days.
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. Study was supported by grants from Ortho‐Biotech and Schein Pharmaceuticals.