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 |