Rayyan 2012.

Methods	Design: double‐blind RCT Setting: single‐centre at Department of Neonatology, University Hospitals, Leuven, Belgium Enrolment period: November 2004 to February 2006. I. Allocation concealment: yes II. Blinding of intervention: yes III. Blinding of outcome measurement(s): yes IV. Complete follow‐up: yes Study duration: 15 days or until last intravenous infusion. Main study period was until day 7 of treatment; all infants were followed up until discharge. For statistical analysis, the last value was carried forward. Adverse events were reported until 6 days after the end of last infusion.
Participants	Inclusion criteria: < 34 weeks' gestation preterm infants with bodyweight 500–2000 g, who received PN for ≥ 7 days. Exclusion criteria: extremely preterm infants, severe congenital malformations, heart failure, organ damage, anuria, haemolytic disease, thrombocytopenia, oxygen saturations < 80% for > 2 hours, severe acidosis, use of catecholamines, hypoxic‐ischaemic encephalopathy and multiorgan failure.
Interventions	Group 1 (n = 26): MOFS‐LE; 20% SMOFlipid Group 2 (n = 27): S‐LE; 20% Intralipid LE were given for ≥ 7 days and up to 14 days, peripherally or centrally. Enteral intake was allowed as per protocol, i.e. < 30% of the total lipid intake on days 1–3, < 50% on days 4–7 and < 70% on days 8–14 of the total energy intake. Daily target dosage of fat started at 1.0 g/kg/day on days 1–3 and was increased to 2 g/kg/day on day 4, 3 g/kg/day on day 5, and 3.5 g/kg/day from day 6 onwards. Other components of PN were given as standardised solutions at the discretion of the investigator.
Outcomes	Primary safety outcome: TG levels Primary efficacy outcome: change in bodyweight at day 8 from baseline Secondary outcomes: blood counts and biochemical parameters Clinical assessments (heart rate, temperature, blood pressure, bodyweight, oxygen therapy) were performed daily from day 0 (prestudy visit) to study termination, either on day 15 or following the last infusion of study treatment (post‐treatment).
Notes	Financial disclosure: supported by the Fund for Scientific Research, Flanders (Belgium) J a Fundamental Clinical Investigatorship (1 800209 N) and a research grant (1506409 N). Sponsored by Fresenius Kabi, Bad Homburg vor der Höhe, Germany. Authors: Hugo Devlieger and Frank Jochum received speaking honoraria and consulting fees from Fresenius Kabi. The publication of the supplement in which this article appeared was sponsored by Nestlé Nutrition Institute.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "using the software RANCODE," "The randomisation was stratified by weight‐ 500 to 1000, 1000 to 1500, 1501 to 2000 g." Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote: "Randomization list was prepared prior to the study and lipid emulsion dispensed by pharmacy." Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Double blind controlled," "… the study and control infusions were of the same size and identical appearance," "Infusions were prepared in the hospital pharmacy identified only by the patient number on the outside of packaging." Comment: probably done.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: probably done. The review authors agreed that the risk was low.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: protocol violations/preterm discontinuation occurred only in 3 participants in the SMOFlipid group and in 4 participants in the Intralipid group (balanced in both groups). The trial profile and participant flow was well described. All outcome data are provided.
Selective reporting (reporting bias)	Unclear risk	Comment: the protocol for the study was not available so we could not ascertain any deviation from the protocol. Data could not be used for sepsis (it was reported as a combined outcome of infection and infestations).
Other bias	Low risk	Comment: none identified.