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. 2017 Nov 16;2017(11):CD004863. doi: 10.1002/14651858.CD004863.pub5
Methods Randomised controlled trial Study location: single centre in Italy Study period: not stated
Participants 63 preterm infants with birth weight < 1750 grams and gestational age < 32 weeks, between the second day and 8 weeks of life
Interventions 22 infants in EPO + iron group received 400 IU EPO (Eprex, Cilag, Italy) per kg 3 times a week (high dose) + 20 mg/kg/week of IV iron (high dose). 20 infants in EPO group received EPO 400 IU/kg 3 times a week (high dose) without iron (low dose). 21 infants in the control group received no treatment or placebo. Treatment was continued to the eighth week of life (or until hospital discharge). EPO was administered IV if the participant had an IV line, then was continued SC at the same dose. All infants were fed the same preterm formula and received 80 mcg/kg of folic acid and 25 IU/d of vitamin E during the study period. No oral iron supplements were given during the study period.
Outcomes Mean number of blood transfusions (95% CI) BPD (age not stated) IVH (grade not stated) Sepsis ROP (stage not stated) Days in hospital
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 Infants randomly allocated
Blinding of participants and personnel (performance bias) All outcomes Unclear risk No placebo was administered. Personnel were aware of treatments.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No placebo was administered. 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