Koksal 2011.

Study characteristics
Methods	Single centre blinded randomised trial in 64 preterm infants done at NICU in Division of Neonatology, Görükle, Bursa, Turkey. Study enrolment: September 2005‐December 2009 I. Allocation concealment ‐ yes II. Blinding of intervention ‐ cannot tell III. Blinding of outcome measurement(s) ‐ cannot tell IV. Complete follow‐up ‐ yes
Participants	Inclusion criteria: ≤ 34 weeks, admission to NICU within 24 h after birth, and TPN requirement expected to be ≥ 80% of the total energy intake during the study. Exclusion criteria: Severe malformations, hyperlipidaemia, metabolic disease, enteral nutrition > 20 ml/kg/day and transfusion > 15 ml/kg/day.
Interventions	Infants were randomised to receive either: 1) 20% ClinOleic® (OS‐LE) (n = 32) OR 2) 20% Intralipid® (S‐LE) (n = 32) LE was started within 72 h after the baseline blood sample was obtained. LE was infused at 1, 2, 3 g/kg/day on first 3 days and 3 g/kg/day over the next 4 days in both groups. After 7 days of LE, infusion was stopped and blood samples taken after 6 hours. Study endpoint was day 7 for total anti‐oxidant capacity (primary outcome). The secondary clinical outcomes have been reported until discharge.
Outcomes	Primary outcome: To evaluate the total anti‐oxidant capacity in both lipid emulsions at day 7 (not significantly different between groups) Secondary outcomes: To assess neonatal morbidity and the biochemical indices after LE administration. The biochemical indices were also compared at day 7. The neonatal morbidities have been reported till discharge (including ROP, BPD, IVH, NEC, RDS and sepsis).
Notes	1. No source of funding has been stated. 2. No growth outcomes were provided in the study report, however these were provided by the study authors on request. 3. Unpublished data were provided by the authors.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Block randomisation was performed using a computer‐generated code." Comment: Probably done.
Allocation concealment (selection bias)	Low risk	Quote: "The coded emulsion was prepared and labelled by the blinded clinical pharmacist." Comment: Probably done.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Outcomes have been reported for all participants.
Selective reporting (reporting bias)	Unclear risk	Comment: The protocol for the study was not available to us so we cannot ascertain any deviation from the protocol.
Other bias	Unclear risk	Comment: This study contributed to high heterogeneity in the outcomes of ventilation duration and duration of oxygen therapy (standard deviation data were confirmed by authors).
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Randomly assigned in a double‐blind manner," "The coded emulsion was prepared and labelled by the blinded clinical pharmacist." Comment: The authors have not provided details of how blinding was achieved.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Parents, trial physicians and clinical staff were blinded to the lipid content of the TPN." Comment: The authors have not provided details of how blinding was achieved.