Safety and Efficacy of a Lipid Emulsion Containing a Mixture of Soybean Oil, Medium-chain Triglycerides, Olive Oil, and Fish Oil: A Randomised, Double-blind Clinical Trial in Premature Infants Requiring Parenteral Nutrition

Objectives: Safety, tolerability, and efficacy of a novel lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil (SMOFlipid 20%) with reduced n-6 fatty acids (FA), increased monounsaturated and n-3 FA, and enriched in vitamin E were evaluated in premature infants compared with a soybean oil-based emulsion. Patients and Methods: Sixty (30/30) premature neonates (age 3-7 days, gestational age <= 34 weeks, birth weights 1000-2500 g) received parenteral nutrition (PN) with either SMOFlipid 20% (study group) or a conventional lipid emulsion (Intralipid 20%, control group) for a minimum of 7 up to 14 days. Lipid supply started at 0.5 g . kg body weight(-1) . day(-1) on day 1 and increased stepwise (by 0.5 g) up to 2 g . kg body weight(-1) . day(-1) on days 4 to 14. Safety and efficacy parameters were assessed on days 0, 8, and 15 if PN was continued. Results: Adverse events, serum triglycerides, vital signs, local tolerance, and clinical laboratory did not show noticeable group differences, confirming the safety of study treatment. At study end, gamma-glutamyl transferase was lower in the study versus the control group (107.8 +/- 81.7 vs 188.8 +/- 176.7 IU/L, P < 0.05). The relative increase in body weight (day 8 vs baseline) was 5.0% +/- 6.5% versus 5.1% +/- 6.6% (study vs control, not significant). In the study group, an increase in n-3 FA in red blood cell phospholipids and n-3: n-6 FA ratio was observed. Plasma alpha-tocopherol (study vs control) was increased versus baseline on day 8 (26.35 +/- 10.03 vs 3.67 +/- 8.06 mu mol/L, P < 0.05) and at study termination (26.97 +/- 18.32 vs 8.73 +/- 11.41 mu mol/L, P < 0.05). Conclusions: Parenteral infusion of SMOFlipid was safe and well tolerated and showed a potential beneficial influence on cholestasis, n-3 FA, and vitamin E status in premature infants requiring PN.