Methods | Randomised controlled trial Study location: 5 centres in Europe Study period: April 1989 to February 1990 |
|
Participants | 93 infants with PMA of 28 to 32 completed weeks' gestation | |
Interventions | 43 infants in the EPO group received EPO (Boehringer Mannheim GmbH) 30 IU/kg SC every third day (70 IU/kg/week, low dose) from the fourth to the 25th day of life. 50 control infants did not receive SC injections of placebo but were managed identically. Elemental iron treatment was started on day 14 with 2 mg/d orally. | |
Outcomes | Use of 1 or more red blood cell transfusions Total volume of blood transfused per infant Mortality Chronic lung disease ROP (infants were followed for ROP, but results were not reported) IVH NEC BPD Hypertension Renal failure PDA | |
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) | Low risk | Prenumbered sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Control infants were not given subcutaneous injections of placebo. Personnel were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Control infants were not given subcutaneous injections of placebo. Assessors were not blinded. |
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 |