Methods |
Randomised controlled trial
Study location: single centre in Italy
Study period: not stated |
Participants |
22 preterm infants with gestational age < 32 weeks, birth weight < 1750 grams, and age > 2 days |
Interventions |
11 infants in the EPO group received EPO (unnamed product), 400 IU, 3 times weekly, IV (400 IU/mL saline solution for 1 to 2 minutes) if IV line in place (1200 IU/kg/week, high dose), then continued SC, plus iron (h) 20 mg/kg once a week IV (high‐dose iron) from second day of life until discharge.
11 infants in the control group did not receive EPO or iron. |
Outcomes |
Number of transfusions
Number of donor exposures (range)
Mortality
Neutropenia
Hospital stay in days
Side effects |
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 assigned |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Control group received no placebo. Personnel were not blinded. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Control group received no placebo. Personnel were not blinded. |
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 |