Demirel 2011.

Study characteristics
Methods	Randomised prospective study in VLBW preterms in a single centre conducted at NICU at Zekai Tahir Burak Maternity Teaching Hospital in Turkey. Study enrolment from January 2010 to October 2010. I. Allocation concealment ‐ cannot tell II. Blinding of intervention ‐ no III. Blinding of outcome measurement(s) ‐ no IV. Complete follow‐up ‐ yes (however deaths were excluded)
Participants	Inclusion criteria: preterm infants ≤ 32 weeks gestation and receiving ≥ 40% parenteral calories at 14th day of life. Exclusion criteria: metabolic disorders, congenital anomalies, severe unconjugated hyperbilirubinaemia, using medications in competition with bilirubin, birth asphyxia and death within 14 days of life.
Interventions	The infants were randomised to receive either: 1) ClinOleic® (n = 20) OR 2) Intralipid® (n = 20) TPN protocol: Lipid emulsion was started on day 2 of life at 1 g/kg/day and increased daily by 1g/kg/day to 3 g/kg/day (24 hour infusion). Amino acids were given as Primene® 10% besides glucose, electrolytes and vitamins. Enteral feeding started on day 2, lipids started on day 2.
Outcomes	Main outcome measures: Plasma lipid concentrations and acyl carnitine profile. Other outcomes: Gestational age, birth weight, sex, APGAR scores, day 14 weight, RDS, ROP and sepsis. No data provided for NEC and BPD. Liver function tests (ALT, AST, GGT), lipid profile, and carnitine levels were recorded.
Notes	Authors postulated that higher levels of hexanoyl carnitine reflecting defective mitochondrial transport of hexanoyl may lead to immunosuppression which may be the cause of higher sepsis risk in the Intralipid® group (hexanoyl carnitine levels 2.18 ± 2.10 in Group I (Intralipid®) and 0.38 ± 0.12 μM in Group II (ClinOleic®); P value 0.005).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Using computer‐generated randomisation sequence." Comment: Probably done.
Allocation concealment (selection bias)	Unclear risk	Comment: The details of allocation concealment have not been mentioned.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Outcomes were reported for all included participants.
Selective reporting (reporting bias)	Unclear risk	Comment: Study protocol is not available to us so we can not ascertain any deviation from the protocol. Also, data were not provided for outcomes of NEC and BPD which have been reported as "statistically insignificant between the groups" (data for these outcomes could not be used in meta‐analyses).
Other bias	High risk	Quote: "The major limitation of our study was based on the randomisation method based on per protocol. We analysed the patients that fulfil the inclusion criteria at the 14th day of life." "Only patients who were receiving 40% of calories parenterally at Day 14 were included in the study. Those who died were also excluded from the study. This methodology can introduce problems with randomisation design and serious bias". Comment: Possibly high risk.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Not a blinded study.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: Not a blinded study.