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

ABSTRACT 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, γ‐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 α‐tocopherol (study vs control) was increased versus baseline on day 8 (26.35 ± 10.03 vs 3.67 ± 8.06 μmol/L, P < 0.05) and at study termination (26.97 ± 18.32 vs 8.73 ± 11.41 μmol/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.