| Methods |
Randomised double‐blind controlled clinical trial
Study location: single centre, Chile
Study period: April 1998 to December 1999 |
| Participants |
60 newborn infants under 1500 grams birth weight; mean age at entry in the EPO group 7.75 ± 2.42 days, and mean age at entry in the control group 7.96 ± 2.44 days |
| Interventions |
29 infants in the EPO group received r‐EPO (Eritropoyetina del Laboraorio Andromaco) 200 IU/kg SC, 3 times a week (600 IU/kg/week, high dose), during 4 weeks.
31 infants in the control group received similar volume of isotonic saline solution in similar fashion.
All infants received oral iron at a dose of 3 mg/kg/d (low dose). |
| Outcomes |
Number of transfusions per infant
Sepsis
IVH |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No information presented |
| Allocation concealment (selection bias) |
Unclear risk |
"were randomised ina double‐blind fashion" ‐ but no specific information provided |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
No specific information provided |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No specific information provided |
| 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 |
