Ohls 1995.
| Methods | Randomised controlled trial Study location: single centre, USA Study period: not stated | |
| Participants | 20 ill newborn VLBW infants, less than 48 hours of age, weighing between 750 and 1500 grams at birth with GA > 27 weeks | |
| Interventions | 10 infants in the EPO group received EPO (unnamed product), 200 IU/kg/d (1400 IU/kg/week, high dose) IV for 14 consecutive days. 10 infants in the control group received similar volume of 0.9% saline solution in similar fashion as placebo. Infants in both groups received iron, 2 mg/kg per day orally, when they were taking 70 mL/kg/d enterally, which was increased to 6 mg/kg per day (high dose) when infants were receiving more than 100 mL/kg per day of feeds. | |
| Outcomes | Use of 1 or more red blood cell transfusions Total volume of blood transfused per infant Number of transfusions per infant BPD Neutropenia NEC IVH 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 were randomly selected. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | All caregivers and investigators were masked to treatment groups. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | All caregivers and investigators were masked to treatment groups. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up: yes Investigators found no differences in the number of infants with BPD, IVH, or NEC (data not shown). |
| 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. After the interim analysis, the study was discontinued because of significant differences between groups in numbers of transfusions. |
| Other bias | Low risk | Appears free of other bias |