Tomsits 2010.

Study characteristics
Methods	Single centre randomised controlled trial done at the Department of Paediatrics at Semmelweis University, Budapest, Hungary. Study enrolment: April 2004‐January 2006. I. Allocation concealment ‐ cannot tell II. Blinding of intervention ‐ cannot tell III. Blinding of outcome measurement(s) ‐ cannot tell IV. Complete follow‐up ‐ yes Both intention to treat and per protocol analysis were performed ‐ both with the last observation carried forward. Stratified study with the following strata: 1000‐1499 g, 1500‐1999 g and 2000 to 2500 g
Participants	Inclusion criteria: < 34 week gestation preterm infants aged 3 to 7 days expected to receive TPN for ≥ 7 days. Exclusion criteria: None mentioned.
Interventions	60 infants born < 34 weeks gestation were randomised to receive either: 1) MOFS‐LE: (20% SMOF®; n = 30) 2) S‐LE: (20% Iintralipid®; n = 30) LE was started at 0.5 g/kg/day on day 1 and was increased by increments of 0.5 g/kg/day daily up to a maximum of 2 g/kg/day on days 4 to 14. Additional oral/enteral intake comprising < 20% at baseline, < 30% on days 1 to 3, and < 50% on days 4 to 14 of the total energy intake was permitted if appropriate. Other components of PN were given at the discretion of the investigator.
Outcomes	Outcomes were evaluated on day 0, 8 and 15. Primary efficacy outcome: Change in weight from day 1 to day 8. Secondary efficacy outcomes: Mechanical ventilation/oxygen therapy and RBC fatty acid profile. Primary safety outcome: Serum triglycerides. Secondary safety outcomes: Vital signs, hematology, coagulation profile, and liver enzymes. The study also reported on growth rate and sepsis.
Notes	1. No funding source mentioned. 2. 57 adverse events ‐ all mild, some outcomes grouped into composite groups, sepsis was reported as infections and infestations. 3. Decreased GGT in the SMOFlipid® group (and increased GGT in the Iintralipid® group, P value < 0.05). 4. The SMOFlipid® group had lower GGT, higher ω‐3, RBC, eicosapentaenoic acid levels, and α‐tocopherol levels.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "...randomised to receive PN..." Comment: Method of random sequence generation is not mentioned.
Allocation concealment (selection bias)	Unclear risk	Comment: Details are not provided.
Incomplete outcome data (attrition bias) All outcomes	Low risk	9 infants (15% participants; 4 in the study group) terminated the study early and were included in the intention to treat analysis with last observation carried forward. Out of 9, in 7 "oral feeding reached exclusion criteria" and in 2 consent was withdrawn. Missing subjects are balanced in numbers across intervention groups, however it is not mentioned to which group the 2 infants where consent was withdrawn belonged. As the data is provided for the ITT set (all participants), the reviewers agreed to give a low risk rating.
Selective reporting (reporting bias)	Unclear risk	The study protocol was not available to us. Some side effects were grouped together (infections and infestations) and could not be used in the meta‐analysis for sepsis. Ventilation and oxygen duration appears to be a combined outcome. In the absence of the study protocol we have assigned the risk category as "unknown."
Other bias	Low risk	None identified.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "were randomised to receive in a double blind manner..." Comment: Details of how blinding was achieved were not mentioned by the authors.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "were randomised to receive in a double blind manner..." Comment: Details of blinding were not mentioned by the authors.