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 |