Schanler 2005

Methods	Randomised controlled trial
Participants	173 infants of gestational age < 30 weeks, whose mothers intended to breastfeed but whose own milk became insufficient from birth until 90 days of age or hospital discharge North Shore University Hospital, New York, USA, 2000 to 2003
Interventions	Preterm formula (N = 81) versus unfortified donor breast milk (N = 92) given as a supplement to maternal breast milk
Outcomes	Incidence of late‐onset invasive infection and NEC, duration of hospitalisation and growth during the study period (weight gain, head circumference increment and length increment)
Notes	Participating infants received small quantities (20 mL/kg/day) of their own mother's milk during the first week after birth and continued for 3 to 5 days before the volume was advanced. Milk intake was increased by 20 mL/kg/day to 100 mL/kg/day at which time human milk fortifier was added. Subsequently the volume of fortified human milk was advanced by 20 mL/kg/day until 160 mL/kg/day was achieved. If no mother's milk was available and the baby was assigned to donor breast milk then a similar advancement and fortification protocol was followed. For all infants, adjustments in milk intake between 160 mL/kg/day and 200 mL/kg/day were recommended to ensure an average weekly weight gain of at least 15 g/kg per day. 17 enrolled infants were switched from donor breast milk to preterm formula because of poor weight gain but all of these analyses were by intention‐to‐treat. However, 7 infants who were never fed (3 in the donor milk group, 4 in the formula group) were excluded from the analyses.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Method not stated explicitly but very likely to be computer‐generated since the random sequence was "an unbalanced blocked design, according to the stratification variables of gestational age and receipt of prenatal steroids"
Allocation concealment (selection bias)	Low risk	Allocation was "performed by the research nurse coordinator with sealed opaque envelopes"
Blinding (performance bias and detection bias) All outcomes	High risk	Unblinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete follow‐up
Selective reporting (reporting bias)	Unclear risk	Protocol not available
Other bias	Unclear risk	Funded by the US National Institute of Child Health and Human Development and the National Institutes of Health General Clinical Research Center, Baylor College of Medicine, USA