Fauchère 2008.
Methods | Randomised controlled trial Study location: single centre in Switzerland Study period: September 2005 through November 2006 | |
Participants | 45 preterm infants born between 24 6/7 and 31 6/7 weeks' gestation | |
Interventions | 30 infants in the EPO group received 3000 IU rhEPO/kg (Epoietin Beta, Roche, Basel Switzerland) IV 3 to 6, 12 to 18, and 36 to 42 hours after birth (high dose). No infant was treated later with rhEPO for anaemia of prematurity. 15 infants in the placebo group received the same volume of 0.9% NaCl (indistinguishable from rhEPO). Use of iron was not mentioned. | |
Outcomes | Mortality IVH (all grades and grades III to IV) Persistent periventricular echodensity ROP (all stages and stages 3 to 4) Sepsis NEC (stage not reported) BPD at 36 weeks' PMA | |
Notes | Study was supported by Roche Foundation for Anemia Research. Infants who were 26 0/7 to 31 6/7 weeks' PMA at birth were included in another study by the same group (Fauchère 2015). The first author ‐ Dr. Fauchère ‐ informed us with that the study included 8 infants who were < 26 weeks' PMA at enrolment (6 infants in the EPO group and 2 in the placebo group). 3 survivors were included in the < 26 weeks' PMA group (1 infant in the EPO group and 2 in the placebo group). We report on mortality for these 8 infants under Fauchère 2008. We report on MDI, PDI, CP, vision, and hearing for the 3 survivors under Fauchère 2008. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐based random‐number generator |
Allocation concealment (selection bias) | Low risk | Assignment was made by the hospital pharmacy. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Normal saline was given as the placebo intervention; it was indistinguishable from the rhEPO solution. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Normal saline was given as the placebo intervention; it was indistinguishable from the rhEPO solution. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all randomised infants |
Selective reporting (reporting bias) | Unclear risk | Study was registered at www.clinicaltrials.gov (NCT00413946) in December 2006, after the last participant had been enrolled in November 2006. Registration was for the larger study published in 2015 (Fauchère 2015). The protocol for the early part of 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 |