Objectives: Fat emulsions used in Australia for parenteral nutrition in preterm neonates have been based on either soybean oil or olive oil (OO). OO lipid Clinoleic has a high ratio of n-6 to n-3 fatty acids (9:1); this may not be ideal for long-chain polyunsaturated fatty acids supply. Newly available SMOFlipid has an appropriate ratio of n-6 to n-3 fatty acids (2.5:1). SMOFlipid also contains OO (25%), coconut oil (30%), and soybean oil (30%). The aims of the study were to evaluate the safety of the SMOFlipid and to test the hypothesis that SMOFlipid would lead to increased omega-3 long-chain polyunsaturated fatty acid levels and reduced oxidative stress as compared with Clinoleic in preterm neonates (<30 weeks).
Methods: Preterm neonates (23–30 weeks) were randomised to receive Clinoleic or SMOFlipid emulsion for 7 days. Investigators and outcome assessors were masked to allocation. Plasma F2-isoprostanes (lipid peroxidation marker), red blood cell fatty acids, and vitamin E were measured before and after the study. Blood culture positive sepsis and growth were monitored for safety.
Results: Thirty of 34 participants completed the study. Both emulsions were well tolerated without any adverse events. F2-isoprostane levels were reduced in the SMOFlipid group as compared with baseline. Eicosapentanoic acid and vitamin E levels were significantly increased in the SMOFlipid group. Oleic acid and linoleic acid levels were increased in both groups. No significant differences were noted in poststudy docosahexaenoic acid levels in both groups despite higher levels of docosahexaenoic acid in SMOFlipid.
Conclusions: SMOFlipid was safe, well tolerated, and showed beneficial effect in terms of reduction of oxidative stress by reducing lipid peroxidation levels in high-risk preterm neonates.
*Department of Neonatal Paediatrics, King Edward Memorial Hospital Western Australia
†School of Medicine and Pharmacology, University of Western Australia
‡Department of Pharmacy, King Edward Memorial Hospital for Women, Perth, Australia.
Address correspondence and reprint requests to Dr Girish Deshpande, FRACP, MSc (e-mail: firstname.lastname@example.org).
Received 1 February, 2013
Accepted 27 August, 2013
Abstract presented at the following meetings: oral presentation at PSANZ 2012 (published as an abstract in J Paediatr Child Health 2012; 48: A143), oral presentation at PAS/SPR 2012 (published in Proc SPR/PAS 2012, abstr no. 2775.4).
This study was funded by a new investigator research grant from the Women's and Infant's Research Institute (grant no. RG510).
Australia New Zealand clinical trial registration no. ACTRN12609001017213.
G.D., K.S., T.A.M., and K.D.C. have received partial funding from Fresenius Kabi and Baxter Health Care for 2 similar studies. Both trials are investigator-initiated trials and none of the companies had any influence on design, conduct, and reporting of the trials. The other authors report no conflicts of interest.