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 |