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

Yu, Lumeng J.; Anez‐Bustillos, Lorenzo; Mitchell, Paul D.; Ko, Victoria H.; Secor, Jordan D.; Hurley, Alexis; Dao, Duy T.; Fligor, Scott C; Cho, Bennet S.; Tsikis, Savas T; Gura, Kathleen M.; Puder, Mark

doi:10.1002/jpen.2458

Cited by 7 publications

(4 citation statements)

References 44 publications

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“…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.…”

Section: Discussionsupporting

confidence: 90%

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

Li,

Chen,

et al. 2024

J Parenter Enteral Nutr

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BackgroundUsing soybean oil‐based lipid emulsions (Intralipid), which contain higher amounts of omega‐6 fatty acids and phytosterols in parenteral nutrition, is a risk factor for cholestasis (PNAC). An alternative form of a mixed lipid emulsion (SMOFlipid) has been developed to reduce the risk of PNAC, but significant benefits over Intralipid in very low birth weight (VLBW) infants have yet to be demonstrated. The aim of this study was to compare the differences in PNAC incidence in VLBW receiving SMOFlipid vs. Intralipid.MethodsThe study was conducted in Sir Run Run Shaw Hospital of Zhejiang University School of Medicine, China, from January 2016 to March 2022. In total, 235 VLBW infants were administered SMOFlipid or Intralipid for ≥ 21 days and were included in the study. The primary outcome was the incidence of PNAC. Secondary outcomes included bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, late‐onset sepsis, length of stay, weight 28 days after birth, severity of PNAC and the time to reversal of PNAC.ResultsForty‐four VLBW infants (35.5%) in the SMOFlipid group vs. 41 (36.9%) in the Intralipid group achieved PNAC (P = 0.817). The subgroup analysis showed that the peak direct bilirubin level was lower (median [IQR] 55.6 [36.4] vs. 118.4 [77.2] μmol/L, P < 0.001) and the time to reversal of PNAC was shorter (median [IQR] 44 [49] vs. 96 [61]; P < 0.001) in the SMOFlipid group than in the Intralipid group.ConclusionsSMOFlipid may represent a better alternative for VLBW infants who require prolonged parenteral nutrition.This article is protected by copyright. All rights reserved.

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Section: Discussionsupporting

confidence: 90%

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

Li,

Chen,

et al. 2024

J Parenter Enteral Nutr

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“…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).…”

Section: Discussionmentioning

confidence: 99%

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

Hudson

Tyminski

Turner

et al. 2023

Journal of Pediatric Gastroenterology &Amp; Nutrition

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Objectives: Infants with intestinal failure have an increased risk of intestinal failure-associated liver disease (IFALD). Composite intravenous lipid emulsion (ILE) may reduce the risk of cholestasis. The primary outcome was to compare IFALD rates in infants with intestinal failure, between those receiving a composite ILE versus soybean oil ILE. The secondary outcome compared growth between these 2 groups. Methods: At our 2 tertiary neonatal/pediatric hospitals, we identified all patients (≤1 year old) who received ≥6 weeks parenteral nutrition (PN) from 2010 to 2018. Data included liver and growth parameters. IFALD was defined as serum conjugated bilirubin (CB) >33 µmol/L (≥2 mg/dL). Nonparametric tests were used for all comparisons. Results: Fifty infants (35 composite ILE, 15 soybean oil ILE) were included. Those on composite ILE received PN for longer (10.1 vs 7.6 weeks; P = 0.001) and had higher baseline CB (29 vs 6.5 μmol/L; P = 0.001). No differences were found by 6 weeks (14.5 vs 5 μmol/L; P = 0.54) and by PN cessation (4 vs 4 μmol/L; P = 0.33). The proportion of patients with IFALD decreased from 54% to 20% for composite ILE, while stable given soybean oil ILE (7%). There were no differences in weight, length, or head circumference z scores (P > 0.05). Conclusions: In our institutions, over 8 years, chronic intestinal failure was rare. Composite ILE was the predominant lipid choice for infants who needed longer courses of PN or had developed cholestasis. Despite longer PN duration, and higher baseline CB, overall rates of IFALD decreased with composite ILE. Regardless of parenteral lipid used, there were no differences in growth.

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“…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 ].…”

Section: Discussionmentioning

confidence: 99%

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

Gostyńska,

Czerniel,

Kuźmińska

et al. 2023

Pharmaceuticals

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Intestinal failure-associated liver disease (IFALD) is a severe liver injury occurring due to factors related to intestinal failure and parenteral nutrition administration. Different approaches are studied to reduce the risk or ameliorate the course of IFALD, including providing omega-3 fatty acids instead of soybean oil-based lipid emulsion or administering active compounds that exert a hepatoprotective effect. This study aimed to develop, optimize, and characterize magnolol-loaded intravenous lipid emulsion for parenteral nutrition. The preformulation studies allowed for chosen oils mixture of the highest capacity of magnolol solubilization. Then, magnolol-loaded SMOFlipid was developed using the passive incorporation method. The Box–Behnken design and response surface methodology were used to optimize the entrapment efficiency. The optimal formulation was subjected to short-term stress tests, and its effect on normal human liver cells and erythrocytes was determined using the MTT and hemolysis tests, respectively. The optimized magnolol-loaded SMOFlipid was characterized by the mean droplet diameter of 327.6 ± 2.9 nm with a polydispersity index of 0.12 ± 0.02 and zeta potential of −32.8 ± 1.2 mV. The entrapment efficiency of magnolol was above 98%, and pH and osmolality were sufficient for intravenous administration. The magnolol-loaded SMOFlipid samples showed a significantly lower toxic effect than bare SMOFlipid in the same concentration on THLE-2 cells, and revealed an acceptable hemolytic effect of 8.3%. The developed formulation was characterized by satisfactory stability. The in vitro studies showed the reduced cytotoxic effect of MAG-SMOF applied in high concentrations compared to bare SMOFlipid and the non-hemolytic effect on human blood cells. The magnolol-loaded SMOFlipid is promising for further development of hepatoprotective lipid emulsion for parenteral nutrition.

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

Cited by 7 publications

References 44 publications

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

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

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

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

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