Incidence and development of cholestasis in surgical neonates receiving an intravenous mixed‐oil lipid emulsion

Abstract

Background Intestinal failure–associated liver disease (IFALD), initially manifesting as cholestasis, is a complication in neonates receiving parenteral nutrition (PN). Soybean oil lipid emulsion (SOLE), though implicated in IFALD, was the only US Food and Drug Administration (FDA)–approved initial intravenous lipid emulsion (ILE) for infants and children in the United States. A mixed‐oil lipid emulsion (MOLE) gained popularity in patients at risk for IFALD and was recently FDA approved as an initial ILE in children. Given the presence of soybean oil in MOLE, we hypothesized that MOLE would not be effective at preventing cholestasis in surgical neonates. Methods Neonates with gastrointestinal surgical conditions necessitating PN for ≥14 days and receiving MOLE (SMOFlipid) from July 2016 to July 2019 were analyzed retrospectively. Unpaired and pair‐matched historical surgical neonates treated with SOLE (Intralipid) served as controls. The primary outcome measure was development of cholestasis (direct bilirubin ≥2 mg/dl). Results Overall, 63% (10 of 16) of MOLE patients and 22% (30 of 136) of SOLE patients developed cholestasis after ≥14 days of therapy (P = 0.005). The latency to developing cholestasis was significantly shorter in MOLE patients compared with SOLE patients. Conclusion In surgical neonates, MOLE may not prevent cholestasis and should not be considered hepatoprotective. Regardless of ILE source, all surgical neonates should be closely monitored for development of IFALD. To date, there is still no ILE able to prevent IFALD.

Association between two different lipid injectable emulsions and parenteral nutrition–associated cholestasis in very low birth weight infants: A retrospective cohort study

“…However, only one randomized controlled trial showed that cholestasis was significantly lower in fish oil–containing ILEs (0% vs 18.2%; P = 0.011) in VLBW infants than in the pure soybean oil emulsion 23 . Recently, published retrospective studies showed that there was no significant difference in the incidence of PNAC in VLBW infants between SMOFlipid and Intralipid, 15,24–26 which is consistent with the conclusions drawn in this study. In the current study, which reported the incidence of cholestasis, no further comparisons were made between the two ILEs in VLBW infants.…”

Intestinal Failure-Associated Liver Disease and Growth Pre- and Post-Transition to a Composite Lipid Emulsion

“…One of the 7 studies, whose study population consisted of premature infants <34 weeks on 7 days of PN, found that those on composite ILE had significantly lower total bilirubin than those on soybean oil ILE (26). A more recent study by Yu et al (27) that examined neonates with gastrointestinal surgical conditions on ILE for 2 weeks found that infants on a lipid‐restricted soybean oil ILE (1 g/kg/day) had no differences in rates of cholestasis compared to a non‐lipid restricted mixed ILE (3 g/kg/day).…”

The Development of Magnolol-Loaded Intravenous Emulsion with Low Hepatotoxic Potential

“…However, the mix-oils lipid emulsion was characterized by a significantly shorter latency to developing cholestasis. The authors concluded that up to date, there is still no intravenous lipid emulsion able to prevent IFALD [ 28 ]. On the other hand, Daniel et al showed that in pediatric patients, administration of SMOFlipid was associated with a lower prevalence of IFALD than in patients receiving soybean oil-based lipid emulsion [ 29 ].…”