| Methods |
Double‐blind randomised controlled trial
Study location: 3 centres, USA
Study period: not stated |
| Participants |
28 ELBW infants with birth weight ≤ 750 grams who were 72 hours of age or younger |
| Interventions |
15 infants received EPO (unnamed product) 200 IU/kg/d (1400 IU/kg/week, high dose) IV, for 14 consecutive days.
13 infants received placebo as an equivalent volume of diluent in similar fashion.
All infants received 1 mg/kg/d iron dextran in TPN solution during the treatment period (high dose).
All infants received vitamin E 25 IU/d when they tolerated 60 mL/kg/d feeds enterally. |
| Outcomes |
Total volume of blood transfused per infant
Number of transfusions per infant
Mortality
Sepsis
IVH
BPD
ROP
Neutropenia |
| Notes |
It is not stated whether infants who had received blood transfusions before study entry were included, but numbers of transfusions from birth to day 1 are reported; thus infants who had received transfusions 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) |
Low risk |
Infants were randomly assigned in a double‐blind fashion. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Study is described as a double‐blind placebo‐controlled study, and a placebo was used. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Study is described as a double‐blind placebo‐controlled trial, and a placebo was used. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow‐up: yes. Two infants in each group died before the 21‐day study period. |
| 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 |
