The effect of 5 intravenous lipid emulsions on plasma phytosterols in preterm infants receiving parenteral nutrition: a randomized clinical trial.

Randomized clinical trial in very low birth weight preterm infants in the NICU who received parenteral nutrition from birth. Participants were allocated 1:1:1:1:1 to one of five intravenous lipid emulsions, with arm sizes of 30, 30, 27, 29, and 28 infants respectively.

Five intravenous lipid emulsions were compared in preterm infants receiving parenteral nutrition for 21 days: S, 100% soybean oil, 1 g/kg/day; MS, 50% medium-chain triglycerides and 50% soybean oil, 1.5 g/kg/day; MSF, 50% medium-chain triglycerides, 40% soybean oil, and 10% fish oil, 2 g/kg/day; OS, 80% olive oil and 20% soybean oil, 2.5 g/kg/day; and MOSF, 30% medium-chain triglycerides, 25% olive oil, 30% soybean oil, and 15% fish oil, 3 g/kg/day. All were given by daily intravenous infusion from postnatal day 0 to day 21.

Lower-phytosterol emulsions reduced plasma phytosterol exposure, but this did not improve liver outcomes. Plasma phytosterol concentrations were highest in the S group and lowest in the MOSF group on PN days 7 and 14, and the MSF group had significantly lower beta-sitosterol than the MS group. Cumulative phytosterol intake correlated positively with plasma phytosterol concentrations. Cholestasis was rare (3 patients, 2.1%: 1 each in MS, MSF, and MOSF; none in S or OS), and liver function at 6 weeks did not differ across groups; neither phytosterol intake nor plasma phytosterol levels were associated with abnormal liver function.

The trial was relatively small within each arm, with only 27 to 30 infants per group, and the clinical outcome of cholestasis was very rare, limiting power to detect differences in liver disease. Follow-up was limited to 6 weeks, and the study appears to come from a single NICU cohort with unspecified location, which may limit generalizability.