Tolerability and safety of olive oil-based lipid emulsion in critically ill neonates: a blinded randomized trial.
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, F(2)-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 (C18:1omega-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 F(2)-isoprostane levels according to the type of lipid emulsion received.


CONCLUSIONS
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 F(2)-isoprostane levels were detected after 5 d of lipid administration.
Webb
Annette N
AN
Department of Gastroenterology & Clinical Nutrition, The Royal Children's Hospital, Melbourne, Victoria, Australia.
Hardy
Pollyanna
P
Peterkin
Megan
M
Lee
Olive
O
Shalley
Helen
H
Croft
Kevin D
KD
Mori
Trevor A
TA
Heine
Ralf G
RG
Bines
Julie E
JE
D016638:Critical Illness / Q000628:therapy*; D004311:Double-Blind Method; D028441:F2-Isoprostanes / Q000097:blood; D005217:Fat Emulsions, Intravenous / Q000737:chemistry*; D005227:Fatty Acids / Q000032:analysis*; D005260:Female; D006801:Humans; D007227:Infant Nutritional Physiological Phenomena / Q000502:physiology*; D007231:Infant, Newborn; D019787:Linoleic Acid / Q000032:analysis; D008099:Liver / Q000502:physiology; D008297:Male; D019301:Oleic Acid / Q000032:analysis; D000069463:Olive Oil; D010288:Parenteral Nutrition / Q000379:methods*; D010743:Phospholipids / Q000737:chemistry; D010938:Plant Oils / Q000627:therapeutic use*; D013024:Soybean Oil / Q000627:therapeutic use; D016896:Treatment Outcome
D028441:F2-Isoprostanes; D005217:Fat Emulsions, Intravenous; D005227:Fatty Acids; D000069463:Olive Oil; D010743:Phospholipids; D010938:Plant Oils; D019301:Oleic Acid; D013024:Soybean Oil; D019787:Linoleic Acid