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 |
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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 |