| Methods | Non‐blind randomised controlled trial Study location: single centre, Singapore Study period: January 1997 to March 2000 | |
| Participants | 00 VLBW infants, < 33 weeks' GA, hematocrit 40% to 60% at birth | |
| Interventions | 50 infants in the EPO group received EPO (unnamed product) 250 IU/kg/dose SC 3 times a week (750 IU/kg/week, high dose) from day 5 to day 40. 50 infants in the control group did not receive any treatment. Infants in both groups received elemental iron 3 mg/kg/d orally from day 10, increased to 6 mg/kg/d (high dose) when full feeds were well tolerated. | |
| Outcomes | Exposure of a proportion of infants to 1 or more red blood cell transfusions Mean number of erythrocyte transfusions per infant Total volume of blood transfused per infant Mortality ROP (stage not stated) Sepsis NEC BPD (age not stated) Hypertension | |
| 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 were randomised to receive EPO or no drug. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo drug was given to the control group. Personnel were not blinded to study group. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No placebo drug was given to the control group. Outcome assessors were not blinded to study group. |
| 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 |
BP: blood pressure. BPD: bronchopulmonary dysplasia. BSID: Bayley Scales of Infant Development. BW: birth weight. CI: confidence interval. CP: cerebral palsy. ELBW: extremely low birth weight. EPO: erythropoietin. GA: gestational age. g: grams. Hct: hematocrit. IS: iron sucrose. ITT: intention‐to‐treat. IU: international units. IV: intravenous/intravenously. IVH: intraventricular haemorrhage. MDI: Mental Development Index. MRI: magnetic resonance imaging. NEC: necrotising enterocolitis. PDI: Psychomotor Development Index. PMA: postmenstrual age. PVL: periventricular leukomalacia. RDS: respiratory depression syndrome. rhEPO: recombinant human EPO. rhG‐CSF: recombinant human granulocyte colony‐stimulating factor. ROP: retinopathy of prematurity. SC: subcutaneous/subcutaneously. TPN: total parenteral nutrition. u/s: ultrasound. VLBW: very low birth weight.