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. 2019 Jul 19;2019(7):CD002971. doi: 10.1002/14651858.CD002971.pub5

Cristofalo 2013.

Methods Randomised controlled trial
Participants 53 newborn infants: birth weight 500 g to 1250 g
 Exclusions: major congenital abnormalities, high likelihood of transfer to a non‐study site after 48 hours
 Seven neonatal intensive care units: six in USA, one in Austria
(Probably) 2010 to 2012
Interventions Preterm formula milk (N = 24) versus fortified (with human milk‐based fortifier), pasteurised donor breast milk (N = 29). Assigned until 91 days after birth, or discharge, or oral feeding at least 50% of feeds
Outcomes Duration of parenteral nutrition, growth, respiratory support, and NEC
Notes Additional information on methods courtesy of Dr Cristafalo (April 2014)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random sequence generated centrally in permuted blocks stratified by investigational site
Allocation concealment (selection bias) Low risk Allocation outcome provided to an individual at each site who was not connected with the evaluation of outcomes for participants
Blinding (performance bias and detection bias) 
 All outcomes Low risk Investigators, caregivers, and families were masked
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 100% follow‐up
Selective reporting (reporting bias) Low risk No deviations from protocol
Other bias Unclear risk Funded by Prolacta Bioscience