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Enrollment closed: Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation (clinicaltrials.gov) - Apr 20, 2023 P1, N=20, Active, not recruiting, The probability of efficacy was superior to that of HT for Caffeine, SAG, Allopurinol, Melatonin, Clemastine, Recruiting --> Active, not recruiting
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Trial completion date, Trial primary completion date: Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC) (clinicaltrials.gov) - Mar 16, 2022 P=N/A, N=40, Not yet recruiting, The parenteral provision of n-3 fatty acids appears to protect against proinflammatory bacteria in the gut and against the increased presence of JVC-associated bacteria as measured by circulating bacterial DNA. Trial completion date: Jan 2027 --> May 2029 | Trial primary completion date: Jan 2027 --> May 2028
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Trial completion, Enrollment change: Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - (clinicaltrials.gov) - Jan 5, 2022 P2, N=23, Completed, Children with IFALD who received FOLE had fewer extrahepatic AEs including a decreased incidence of bleeding, preterm co-morbidities, and lipid intolerance signs compared with children with IFALD who received SOLE. Recruiting --> Completed | N=40 --> 23
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Preclinical, Journal: Three Lipid Emulsions Reduce Staphylococcus aureus-Stimulated Phagocytosis in Mouse RAW264.7 Cells. (Pubmed Central) - Dec 27, 2021 In the present study, we used a model of S. aureus-infected mouse RAW264.7 macrophages to determine the influence of three different compositions of lipid emulsions (Lipofundin, ClinOleic, and Omegaven) on reactive oxygen species (ROS) production, phagocytosis, and bacterial survival...These results suggest that the three lipid emulsions diminished ROS production and phagocytosis, resulting in increased bacterial survival. PI3K predominantly mediated the inhibitory effects of the lipid emulsions on the phagocytosis of mouse RAW264.7 macrophages.
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Journal: Head Circumference Growth Is Enhanced by SMOFlipid in Preterm Neonates. (Pubmed Central) - Aug 8, 2021 The routine perioperative use of two single doses of intravenous Ω3-FA (100ml Omegaven) cannot be recommended in patients undergoing liver surgery (Grade A recommendation). Our data offer preliminary evidence of improved brain growth in those receiving a balanced lipid emulsion as compared with a soybean oil emulsion.
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Retrospective data, Journal: High Dose Intravenous Fish Oil Reduces Inflammation-A Retrospective Tale from Two Centers. (Pubmed Central) - Apr 1, 2021 PN with pure fish oil ILE reduces some inflammatory parameters in IBD and maintains liver function parameters in CIF patients. Fish oil might become a valuable ingredient in both short- and long-term PN in patients at risk of liver dysfunction.
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Trial completion: Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis (clinicaltrials.gov) - Jan 27, 2021 P1/2, N=12, Completed, Use of SMOFlipid resulted in decreased development of IF-associated liver disease in patients with IF when assessed using biochemical tests. Enrolling by invitation --> Completed
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Journal: The effect of ω-3 polyunsaturated fatty acids on the liver lipidome, proteome and bile acid profile: parenteral versus enteral administration. (Pubmed Central) - Dec 18, 2020 Using omics´ approach, we determined serum and liver lipidome, liver proteome, and liver bile acid profile as well as markers of inflammation and oxidative stress in rats administered either ω-6 PUFA based lipid emulsion (Intralipid) or ω-6/ω-3 PUFA blend (Intralipid/Omegaven) via the enteral or parenteral route...physiological BAs spectrum. All these findings may contribute to the explanation of ω-3 PUFA protective effects in the context of PN.
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Journal: The Power of Networking and Lessons Learned From Omegaven. (Pubmed Central) - Nov 22, 2020 First used off label to treat a soy-allergic patient dependent on parenteral nutrition, researchers at Boston Children's Hospital later conducted animal studies on its role in treating and preventing intestinal failure associated with liver injury and later translated it into clinical trials that led to the drug's approval in 2018. This is a recount of those efforts.
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Clinical, Journal, Monotherapy: Use of Fish Oil Intravenous Lipid Emulsions as Monotherapy in the Pediatric Intestinal Failure Patient: Beyond the Package Insert. (Pubmed Central) - Oct 7, 2020 In July 2018, an intravenous lipid emulsion (ILE) composed of 100% fish oil (Omegaven, Fresenius Kabi, Bad Homburg, Germany) received Food and Drug Administration (FDA) approval as a source of fatty acids and calories for infants and children with parenteral nutrition-associated cholestasis...The purpose of this paper is to guide the practitioner on the use of this alternative fat source in clinical practice and augment the material contained in the current package insert. This paper addresses various topics including the identification of which patients would benefit from fish oil ILE, dosing, administration, monitoring, potential adverse effects, and management strategies for fish oil ILE.
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