Yasmeen 2012

Methods	Randomised controlled trial Study location: single centre, Dhaka, Bangladesh Study period: April 2007 to May 2008
Participants	60 VLBW infants, < 7 days of age, < 35 weeks' PMA, and weighing < 1500 grams
Interventions	30 infants were supplemented with rHuEPO 200 IU/kg/dose SC 3 times/week for 2 weeks, started on day 7 of life. EPO group and control group (n = 30) received oral iron 6 mg/kg/d and folic acid 0.5 mg every alternate day up to 12 weeks of age. Administration of both iron and folic acid started from day 14 of life, or as soon as enteral feeding was initiated after day 14.
Outcomes	Mortality is the only outcome that can be ascertained from this study.
Notes	Mortality is the only outcome that can be ascertained from this study. For all other outcomes of interest, including neonates requiring blood transfusion while in hospital, trial authors excluded 13 infants; in the EPO group, 4 infants died during hospital stay, 1 participant did not come in for first follow‐up, and 1 did not come in for second follow‐up. In the control group, 5 infants died during hospital stay and 2 did not come in for second follow‐up. Finally, 24 infants in group 1 and 23 infants in group 2 completed follow‐up until 10 weeks of age. These 13 infants who dropped out were excluded from the analysis. We suggest that infants who died should have been included in both the nominator and the denominator for the outcomes of need for blood transfusion and number of blood transfusions (ITT analysis). A total of 13 infants dropped out of the study, which represents 22% ‐ a very high percentage.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Lottery method
Allocation concealment (selection bias)	Unclear risk	Lottery method
Blinding of participants and personnel (performance bias) All outcomes	High risk	No placebo was used, so personnel could not be blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessors were not blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	22% of the infants dropped out. In‐hospital outcome data did not include deaths. Lack of ITT analysis
Selective reporting (reporting bias)	Unclear risk	The protocol for this study was not available to us, so we are not able to tell whether deviations from the protocol occurred.
Other bias	Low risk	Appears free of other bias