Mihatsch 2002.

Study characteristics
Methods	RCT
Participants	Very low birth weight (< 1500 g) infants
Interventions	Empirical use of extensively hydrolysed (whey‐casein) preterm formula* (n = 41) Standard preterm formula* (n = 46)
Outcomes	Necrotising enterocolitis Proportion of enteral feeds with gastric residual volumes > 5 mL/kg birth weight
Notes	Division of Neonatology and Pediatric Critical Care, Department of Pediatrics, Ulm University, 89070 Ulm, Germany Trial dates: 1999 to 2001 * Energy content of both formulas: 80 kcal/100 mL
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Unclear risk	Sealed envelopes ‐ unclear whether opaque
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	"Double‐blind"; same appearance, but investigators acknowledged different tastes
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Double‐blind"
Incomplete outcome data (attrition bias) All outcomes	High risk	129 infants recruited initially, then 42 excluded post hoc because they received > 10% of enteral intake as human milk
Selective reporting (reporting bias)	Unclear risk	Protocol not available
Other bias	Unclear risk	Funder: Milupa GmbH, Germany (manufacturer of the trial formula)