Haiden 2005.
Methods | Randomised controlled trial Study location: neonatal intensive care units in Vienna, Austria Study period: October 2000 to November 2002 | |
Participants | 40 preterm infants with BW < 800 grams and GA < 32 weeks' gestation | |
Interventions | EPO group (n = 21) received 300 IU/kg/d of EPO (Erypo, Janssen‐Cilag Pharma, Vienna, Austria) IV (as long as IV access was available), or 700 IU/kg 3 times/week (2100 IU/kg/week, high dose) and iron dextran 1.5 mg/kg/d IV or iron polymerase complex 9 mg/kg/d orally (high dose). Therapy was given until 40 weeks' GA or discharge. Control group (n = 19) did not receive IV iron. Iron was started orally from the 15th day of life, or when infant tolerated 60 mL/kg of enteral feeding, whichever came first Placebo was not used. | |
Outcomes | Use of 1 or more red blood cell transfusions
Number of donors
Mortality NEC PVL IVH (grades I to II) IVH (grades III and IV) Hospital stay BPD (age not stated) ROP (stages I and II) ROP (stages III and IV) |
|
Notes | 47 infants were eligible for enrolment in the study. Four infants were excluded because of parental refusal (n = 2) or IVH grade IV (n = 2). Three infants died before randomisation. The final cohort included 40 infants. 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 | Sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo was administered to the control group. Personnel were aware of group assignments. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No placebo was administered to the control group. Outcome assessors were aware of group assignments. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Complete follow‐up: 47 infants were eligible for enrolment in the study. Four infants were excluded because of parental refusal (n = 2) or IVH grade IV (n = 2). Three infants died before randomisation. The final cohort included 40 infants. |
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 |