Gobel 2003.

Study characteristics
Methods	Double blind randomised study at two NICU in Munich The randomisation was stratified for study centre and birth weight (< 1,250 g and > 1,250 g). I. Allocation concealment ‐ cannot tell II. Blinding of intervention ‐ cannot tell III. Blinding of outcome measurement(s) ‐ cannot tell IV. Complete follow‐up ‐ no Safety analysis was performed on the intention‐to‐treat population (42 treated infants including dropouts), efficacy analysis was performed on the per‐protocol population (33 infants treated for 7 days).
Participants	Inclusion criteria: Preterm infants with gestation range of 28 weeks to < 37 weeks with admission to NICU within 24 hours of birth and PN providing ≥ 80% calories during the study. Exclusion criteria: Severe malformations, inborn error of metabolism, jaundice before randomisation, hyperlipidaemia, bacterial infection and transfusion of packed red blood cells and/or fresh frozen plasma of more than 15 mL/kg (cumulative volume) before baseline blood sampling.
Interventions	Randomised (n = 45) within 72 hours of life to receive: 1) OS‐LE (20% ClinOleic®) n = 24 2) S‐LE (Intralipid 20%®) n = 21 LE was started within 72 hours of birth, given as 24 hour infusions at doses of 0.5, 1.0, and 2.0 g/kg/day on the first 3 consecutive study days and 2 g/kg/day for the next 4 days. The rest of the TPN co‐interventions were the same in the two groups. Vitamin E was not given, minimal enteral nutrition was provided and infants were excluded if the enteral calories exceeded 20% at any time.
Outcomes	Outcomes included levels of triglycerides, cholesterol, phospholipids. Clinical outcomes included hyperbilirubinaemia, bradycardia, apnoea and gastro‐oesophageal reflux. The study reported no serious adverse events in any group. Efficacy outcomes were evaluated in per protocol patients on day 0 and day 8 which included proportions of plasma phospholipid fatty acids, alpha tocopherol levels, and urine malondialdehyde excretion.
Notes	The study was supported by Baxter. Some of authors were affiliated with Baxter research and development centre.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: Method of random sequence generation is not described.
Allocation concealment (selection bias)	Unclear risk	Comment: Details of allocation concealment are not provided.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Initially 45 infants were randomised; 3 infants did not fit inclusion criteria and 9 were excluded as enteral intake exceeded 20%. Intention to treat analysis was done for safety outcomes (including the excluded infants) for initially randomised patients. For this review, the only outcome of interest was hyperbilirubinaemia which was a safety variable. Overall taking all these factors into account, the study was graded as being at low risk of bias.
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.
Other bias	Low risk	Comment: None identified.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "After the study was completed and the database locked, the blind code was opened." Comment: The authors have not mentioned how blinding was achieved.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "After the study was completed and the database locked, the blind code was opened." Comment: The authors have not mentioned how blinding was achieved.