Fauchère 2015.

Methods	Randomised controlled trial Study location: multi‐centre trial in Switzerland Study period: September 2005 to December 2012
Participants	Preterm infants with PMA 26 0/7 to 31 6/7 weeks
Interventions	Experimental intervention: EPO (Epoietin Beta, Roche Basel, Switzerland) (3000 IU/kg BW), equal to 1 mL solution/kg BW, was given IV at < 3, 12 to 18, and 36 to 42 hours after birth over a period of 10 minutes – total dose 9000 IU/kg during first week of life – high dose. Total number randomised: n = 229 infants (1 infant in the EPO group was excluded because the infant did not get the full medication dose as allocated – 229 infants analysed) Control intervention: 1 mL solution/kg BW of NaCl 0.9% IV at < 3, 12 to 18, and 36 to 42 hours after birth over a period of 10 minutes Total number randomised: n = 214 infants (6 infants in the placebo group excluded because they did not receive the full medication dose as allocated – 214 infants analysed)
Outcomes	Mortality ROP IVH Sepsis NEC BPD Survivors without any severe IVH and ROP, IVH, ventricular dilatation, cystic or non‐cystic PVL, ROP, sepsis, NEC, persistent PDA, BPD, hemangioma, ROP grade 4, or need for laser/cryotherapy Length of hospital stay, weight and head circumference at discharge In a separate report by Leuchter R H‐V et al in 2014, a subset of 165 infants (77 assigned to EPO and 88 to placebo) were assessed for brain abnormalities on MRI performed at term‐equivalent age. Infants with abnormal scores for white matter injury, white matter signal intensity, periventricular white matter loss, and grey matter injury were reported. Outcomes at 2 years of age were reported in a separate study by Natalucci G et al in 2016. Outcomes reported included BSID‐II (MDI and PDI), cerebral palsy, severe hearing impairment, severe visual impairment, survival without severe neurodevelopmental impairment, MDI < 70, and PDI < 70. Long‐term outcomes were reported for 365 infants (81%); 191 infants were assigned to EPO, and 174 infants to placebo.
Notes	This study includes infants ≥ 26 weeks from Fauchère 2008. The 2008 study included 6 infants in the EPO group and 2 in the placebo group who were < 26 weeks' PMA. In the EPO group, 5 died and 1 survived. In the placebo group, both infants survived. We report the outcomes of these infants under Fauchère 2008. We received additional information on these 8 infants at < 26 weeks' PMA from Dr. Fauchère.
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 by hospital pharmacy
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Normal saline given as the placebo intervention and indistinguishable from the rhEPO solution
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Normal saline given as the placebo intervention and indistinguishable from the rhEPO solution
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcomes reported for all randomised infants
Selective reporting (reporting bias)	Low risk	Study was registered at www.clinicaltrials.gov (NCT00413946) in December 2006.
Other bias	Low risk	Appears free of other bias