Rayyan 2012.

Study characteristics
Methods	Double blind randomised controlled study done at a single centre at the 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 IV infusion. The main study period was until day 7 of treatment; all subjects 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: Under 34 weeks gestation preterm infants with weight of 500‐2000 g, who received PN for at least 7 days. Exclusion criteria: Extremely premature infants, severe congenital malformations, heart failure, organ damage ‐ anuria, haemolytic disease, thrombocytopenia, oxygen saturations < 80% for more than 2 hours, severe acidosis, use of catecholamines, hypoxic‐ischemic encephalopathy, and multi‐organ failure.
Interventions	Preterm infants (n = 53) were randomised to receive either: 1) 20% SMOFlipid® (n = 26) 2) 20% Intralipid® (n = 27) LE were given for at least 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 was permitted. The daily target dosage of fat started at 1.0 g/kg BW/d on days 1–3 and was increased to 2 g/kg/day on day 4, 3 g/kg BW/d on day 5, and 3.5 g/kg/day from day 6 on. Other components of PN were given as standardised solutions at the discretion of the investigator.
Outcomes	Primary safety outcome ‐ triglyceride levels, until day 8 Primary efficacy outcome ‐ change in body weight at day 8 from baseline. Secondary outcomes ‐ blood counts and biochemical parameters. Clinical assessments (heart rate, temperature, blood pressure, body weight, oxygen therapy) were performed daily from day 0 (pre‐study visit) until study termination, either on day 15 or following the last infusion of study treatment (post‐treatment).
Notes	Financial disclosure: The clinical research is supported by the Fund for Scientific Research, Flanders (Belgium) J a Fundamxntal Clinical Investigatorship (1 800209 N) and a research grant (1506409 N). The study was sponsored by Fresenius Kabi, Bad Homburg, Germany. Authors: Hugo Devlieger and Frank Jochum have received speaking honoraria and consulting fees from Fresenius Kabi. The publication of the supplement in which this article appears is 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‐ 500‐1000, 1000‐1500, 1501‐2000 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.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Protocol violations/premature 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 is well described. All outcome data are provided.
Selective reporting (reporting bias)	Unclear risk	Comment: The protocol for the study was not available to us so we can 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.
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 is low.