Skouroliakou 2010.

Study characteristics
Methods	Randomised controlled trial in preterm infants done in a single centre at the NICU of ‘IASO’ Maternity Hospital in Athens, Greece. Study enrolment: Nov 2008 to April 2009. I. Allocation Concealment ‐ yes II. Blinding of intervention ‐ yes III. Blinding of outcome measurement(s) ‐ yes IV. Complete follow‐up ‐ no
Participants	38 infants were enrolled in the study. Inclusion criteria: Under 32 week gestation preterm infants with birth weight of < 1500 g requiring admission to ICU within 12 hours of birth and expected to receive > 80% of the energy intake by parenteral route in the first 8 days of life and requiring PN for at least 7 days. Exclusion criteria: Inherited metabolic disorders, congenital malformations, transfusion of blood/fresh frozen plasma > 15 ml/kg, and participation in another study.
Interventions	Infants were randomised to receive either: 1) MOFS‐LE: (SMOFlipid ®; n = 19) OR 2) S‐LE: (Inralipid ®; n = 19) 4 different TPN protocols were created based on gestational age/weight/clinical condition. Lipids were started on day 1 or 2 of life (based on gestational age) with a maximum of 3g/kg/day in both the groups. Enteral feeds were allowed at ≤ 20% of total energy intake and started as soon as feasible. Oral feeds were started after at least 14 days of parenteral nutrition for all infants in the study group.
Outcomes	Primary outcome: Oxidation potential (vitamin A, E and total anti‐oxidant potential) Hypothesis: A reduction in oxidative stress in the SMOFlipid® group? Secondary outcomes: Growth parameters, blood count, clinical condition and length of stay (parameters noted on day 0, day 14, and at discharge).
Notes	1. SMOFlipid® was supplied by Freseniius Kabi. 2. Vitamin E and A levels were not affected by the intervention, however TAP level was increased in the SMOFlipid® group, indicating possible reduction in the oxidant stress. 3. Authors mention "none of the children in each group had any side effects related to parenteral nutrition or sepsis."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Computer generated randomisation." Comment: Probably done.
Allocation concealment (selection bias)	Low risk	Quote: "the pharmacist, who was responsible for the placement of each infant in a group (intervention vs control)..." Comment: Statistician and Pharmacist not involved in the trial. Probably done.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: Out of 38 randomised infants there were 6 exclusions (16%) with 5 from the SMOFlipid® group (n = 2 transfusion > 15 ml/kg, n = 1 PN < 7 days, n = 1 transfer to another centre) and 1 from the 20% Intralipid® group (PN < 7 days). (unbalanced exclusions)
Selective reporting (reporting bias)	Unclear risk	Comment: The protocol for the study was not available to us so we cannot ascertain any deviation from the protocol.
Other bias	Low risk	None identified.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "PN were in identical bags" Comment: Probably done.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "PN were in identical bags;" " All medical personnel and participants were blinded to treatment assignment during the whole course of the study" Comment: Probably done.