Omega 3 containing lipid emulsions for the preterm: time for a large RCT

A recent small RCT from Turkey, n=80 (Beken S, Dilli D, Fettah ND, Kabatas EU, Zenciroglu A, Okumus N: The influence of fish-oil lipid emulsions on retinopathy of prematurity in very low birth weight infants: A randomized controlled trial. Early Hum Dev 2013) suggests that retinopathy might be less frequent if we used a lipid emulsion that contained significant amounts of omega3 fatty acids. The study only had 80 infants in the two groups (40 with soybean based Intralipid and the other 40 had SMOFlipid, Soybean, MCT, Olive Oil and Fish Oil based). Babies were very low birth weight (under 1500g) and very preterm (below 32 weeks. Retinopathy occurred in 33% of the Intralipid and 5% of the SMOFLipid group.

SMOFlipid is now licensed in Canada (without any approved indication for the newborn) and is licensed in Europe with an approved indication, I have heard, for neonatal use. The total number of babies in RCTs of SMOFlipid was about 100 before this new trial and now approaches 200. Other observational data, and previous small RCTs all suggest benefit, with a potential reduction in BPD and in cholestasis, and in biochemical indices of lipid tolerance.

Intralipid was introduced into neonatal use over 40 years ago, with almost no objective evaluation. We can’t let this happen again. The time has come to perform a large pragmatic RCT comparing different lipid preparations in very preterm infants. We need to know for sure if there are benefits, and also if it is safe, in our uniquely sensitive group of patients.

About keithbarrington

I am a neonatologist and clinical researcher at Sainte Justine University Health Center in Montréal
This entry was posted in Neonatal Research and tagged , , . Bookmark the permalink.

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