Tolerability and safety of olive oil–based lipid emulsion in critically ill neonates: A blinded randomized trial

Abstract Objective We assessed the safety and tolerability of an olive oil–based lipid emulsion compared with a soybean-based lipid emulsion in critically ill neonates. Methods A double-blinded, randomized study was conducted in critically ill neonates requiring parenteral nutrition in the first week of life. Infants were randomized to receive a lipid emulsion based on olive oil (OO; ClinOleic) or soybean oil (SO; Intralipid) for a minimum of 5 d. Plasma phospholipid fatty acids, F2 -isoprostanes, liver function, and clinical outcome were assessed after 5 d of therapy. Results Seventy-eight neonates (men gestational age 37 wk, range 26–41 wk) received OO ( n = 39) or SO ( n = 39). Both emulsions were well tolerated with no adverse events observed. At day 5, plasma phospholipid oleic acid (C18:1ω-9) levels increased in infants receiving OO compared with lower levels in infants receiving SO (mean percentage ± SD 33.1 ± 6.4 for OO versus 18.6 ± 2.4 for SO; mean difference −14.7 mmol/L, 95% confidence interval −17.5 to −11.9). The increase in plasma phospholipid linoleic acid levels was attenuated in infants receiving OO (mean percentage ± SD 12.6 ± 3.0 for OO versus 23.7 ± 6.9 for SO; adjusted mean 11.4 mmol/L, 95% confidence interval 8.1–14.8). No differences were observed in plasma F2 -isoprostane levels according to the type of lipid emulsion received. Conclusion The OO-based emulsion (ClinOleic) was well tolerated in critically ill neonates. Differences in plasma phospholipids at day 5 reflected the fatty acid composition of the administered emulsion. No significant differences in plasma F2 -isoprostane levels were detected after 5 d of lipid administration.