| Methods |
Randomised controlled trial
Study location: neonatal intensive care unit at Oulu University Hospital, Finland
Study period: March 1998 to May 2000 |
| Participants |
39 infants (BW 700 to 1500 grams, PMA ≤ 30.0 weeks) |
| Interventions |
21 infants received EPO (EPO 250 IU/kg/d during the first 6 days of life IV for a period of 30 minutes) (total dose 1500 IU/kg/week). 18 infants received placebo (isotonic saline as placebo for a period of 30 minutes). None of the infants received iron during the first week of life. |
| Outcomes |
Iron status
Postnatal morbidities and follow‐up at the age of 2 years |
| Notes |
We received additional information from Dr. Peltoniemi. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number table |
| Allocation concealment (selection bias) |
Low risk |
Allocation was concealed, but details are not provided. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Study drug and placebo were put into identical syringes. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Nurses, doctors, and study investigators were blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Outcomes during initial hospital stay reported for all randomised infants. Of 20 surviving children at 2 years of age, 19 were enrolled and 10 were evaluated on Griffiths Developmental Scale. Of 16 surviving placebo group children at 2 years of age, all were enrolled and 9 were evaluated at on Griffiths Developmental Scale. Follow‐up rates for Griffiths Developmental Scale were low (thus unclear risk). |
| Selective reporting (reporting bias) |
Low risk |
The protocol for the study was not available to us. The protocol was written in Finnish, and Dr. Antilla assured Dr. Peltoniemi that no deviations from the protocol occurred. |
| Other bias |
Low risk |
Appears free of other bias |
