Sáenz de Pipaón 2003.

Methods	Randomised controlled trial
Participants	Infants weighing < 1600 grams at birth. Exclusions included infants of diabetic mothers, major congenital anomalies and proven sepsis. Setting: La Paz University Hospital, Madrid, Spain
Interventions	Minimal enteral nutrition (N = 24) vs. enteral fasting (N = 12). On day 1, infants were randomly allocated to either minimal enteral nutrition (10 ml/kg/day on day 1, then 20 ml/kg/day through until day 7) or enteral fasting for 7 days
Outcomes	This was primarily a metabolic study examining whether enteral leucine uptake was affected by trophic feeding Authors also reported time to establish full feeds Communication with authors revealed data were collected on the incidence of necrotising enterocolitis and mortality
Notes	March 2009: clarification of methods and outcome data received from Dr Saenz de Pipaon (principal investigator): "If the mother wished to give breast milk and the baby was allocated to the minimal enteral nutrition group, he or she started on day one to receive breast milk. If the mother was not able or did not wish to give breast milk the infant received formula. If the baby was allocated to the enteral fasting group, breast milk or formula was given from day seven."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Correspondence with principal investigator revealed randomisation involved sealed opaque envelopes with 2:1 allocation ratio
Allocation concealment (selection bias)	Low risk	Satisfactory
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding of care givers or investigators
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No statement about blinding of radiological assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	All data were accounted for