| Methods |
Double‐blind randomised controlled trial
Study location: single centre, Auckland, New Zealand
Study period: 2‐year period 1995 to 1996 |
| Participants |
43 preterm infants < 33 weeks' gestation and < 1700 grams |
| Interventions |
22 infants in EPO group received erythropoietin (Eprex; Janssen‐Cilag, Auckland, New Zealand) at a dose of 1200 IU/kg/week (high dose) SC in 3 divided doses until the age of 3 weeks, when the dose was reduced to 600 IU/kg/week. Treatment continued until 34 weeks' completed gestation, or for a minimum of 3 weeks.
21 infants in the control group received sham treatment, to avoid SC injection.
Ferrous gluconate at a dose of 6 mg of elemental iron/kg/d (high dose) was given to the EPO group once they had attained a postnatal age of 2 weeks and were receiving at least 50% energy intake orally. Those in the control group received 2 mg/kg/d iron from the same age, in a more dilute preparation, so that an equivalent volume was given.
All infants received a multi‐vitamin preparation and vitamin E (25 IU/d). |
| Outcomes |
Use of 1 or more red blood cell transfusions
Number of donors the infant was exposed to
Number of transfusions per infant |
| 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) |
Low risk |
Computer generated |
| Allocation concealment (selection bias) |
Low risk |
Infants were randomised by the hospital pharmacist to receive EPO or no treatment (control group). |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Treatment was administered by a designated study nurse who was not involved in clinical management decisions related to the infants. On each of the treatment days, the nurse collected vials of EPO and saline, and 1‐mL syringes were prepared in a side room. The syringes were labelled with the patient's name. A screen was placed around the bedside; those on EPO received SC injection, and adhesive plaster was placed over the injection site. Those in the control group had plaster applied to a similar site as those on EPO; the sites in both groups were then left covered until the next treatment day. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
See above, under 'Blinding of participants and personnel'. |
| 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 |
