| Methods |
Randomised open controlled study
Study location: 2 centres in South Africa
Study period: not stated |
| Participants |
93 infants < 7 days of life, in room air or requiring 30% oxygen at study entry with birth weight between 900 and 1500 grams
Infants were stratified by weight < 1250 grams and > 1250 grams, then were randomised to 3 treatment groups. |
| Interventions |
32 infants (low‐dose group) received EPO (Recormon) SC, 250 IU/kg 3 times a week (high dose).
31 infants (high‐dose group) received EPO (Recormon) SC, 400 IU/kg 3 times a week (high dose).
30 infants (control group) received standard care.
The endpoint of therapy was reached when the infant was discharged from the hospital.
All infants received a therapeutic dose of 6 mg/kg (high dose) elemental iron orally every day; this was increased to 8 to 10 mg/kg (high‐dose iron) if hypochromic cells accounted for 20% or more.
All infants subsequently received blood transfusions if they met the transfusion criteria. |
| Outcomes |
Use of 1 or more red blood cell transfusions
Total volume (mL/kg) of blood transfused per infant
Number of blood transfusions per infant
Mortality
Sepsis
Hypertension
Length of hospital stay |
| 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 |
Blinding of randomisation unclear |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No placebo was given to the control group. Personnel were aware of treatments. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
No placebo was given to the control group. Outcome assessors were aware of treatments. |
| 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 |
