Methods |
Double‐blind randomised controlled trial Study location: single centre, Mexico Study period: 1995 to 1996 |
Participants |
40 VLBW infants with birth weight between 750 and 1500 grams at < 26 weeks' gestation |
Interventions |
21 infants in the EPO group received EPO (Eprex 4000, Cilag de Mexico SA de CV) 150 units/kg/d (during first 6 weeks of life), 1050 IU/kg/week (high dose), and 19 infants in the control group received placebo. Iron 4 mg/kg/d (low dose) |
Outcomes |
Number of transfusions per group Sepsis NEC IVH (grade not reported) BPD (age not stated) |
Notes |
We could not ascertain whether transfusion guidelines were in place, and if infants who had received blood transfusions before study entry were included. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Unclear |
Allocation concealment (selection bias) |
Unclear risk |
Infants were randomly assigned. |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
Observers were unaware of treatment assignments. Placebo was used. |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Observers were unaware of treatment assignments. Placebo was used. |
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 |