Tomsits 2010.

Methods	Design: single‐centre RCT Setting: Department of Paediatrics at Semmelweis University, Budapest, Hungary Study enrolment: April 2004 to January 2006 I. Allocation concealment: could not determine II. Blinding of intervention: could not determine III. Blinding of outcome measurement(s): could not determine IV. Complete follow‐up: yes Both ITT and per‐protocol analysis were performed: both with the last observation carried forward. Stratified study with the following strata: 1000 to 1499 g, 1500 to 1999 g and 2000 to 2500 g
Participants	Inclusion criteria: preterm infants < 34 weeks' gestation aged 3 to 7 days expected to receive TPN for ≥ 7 days Exclusion criteria: none mentioned
Interventions	60 infants Group 1 (n = 30): MOFS‐LE; 20% SMOF Group 2 (n = 30): S‐LE; 20% Intralipid 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 FA profile Primary safety outcome: serum TG Secondary safety outcomes: vital signs, haematology, coagulation profile and liver enzymes Study also reported growth rate and sepsis.
Notes	No funding source mentioned. 57 adverse events: all mild, some outcomes grouped into composite groups, sepsis was reported as infections and infestations. Decreased GGT in the SMOFlipid group (and increased GGT in the Intralipid group, P < 0.05). The SMOFlipid group had lower GGT, and higher ω‐3, RBC, EPA 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 not mentioned.
Allocation concealment (selection bias)	Unclear risk	Comment: details not provided
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.
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.
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 ITT analysis with last observation carried forward. Out of 9, in 7 "oral feeding reached exclusion criteria" and in 2 consent was withdrawn. Missing participants were balanced in numbers across groups; however, it was 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 review authors agreed to give a low risk rating.
Selective reporting (reporting bias)	Unclear risk	The study protocol was not available. Some adverse effects were grouped (infections and infestations) and could not be used in the meta‐analysis for sepsis. Ventilation and oxygen duration appeared 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.