Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi 
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 78 Diseases   19 Trials   19 Trials   232 News 


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  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    Enrollment change, Trial withdrawal:  Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC) (clinicaltrials.gov) -  Aug 4, 2022   
    P=N/A,  N=0, Withdrawn, 
    The fractions concentration values calculated with the total protein concentration should be used for evaluating SPEP results. N=40 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    Trial completion date, Trial primary completion date:  Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation (clinicaltrials.gov) -  Jun 10, 2022   
    P1,  N=20, Recruiting, 
    Changes in barrier function, including dysregulation of pericytes and perivascular macrophages, provide new targets to reduce postoperative delirium. Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    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
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    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
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    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.
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    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.
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    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.
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    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
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    Phase classification:  Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis (clinicaltrials.gov) -  Jan 12, 2021   
    P=N/A,  N=0, No Longer Available, 
    Enrolling by invitation --> Completed Phase classification: P1/2 --> P=N/A
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    [VIRTUAL] Retrospective evaluation for SMOFlipid fat emulsion in the neonatal intensive care unit () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_4223;    
    Generally, SMOFlipid was switched from Intralipid due to clinical observation of necrotizing enterocolitis and/or if PN was expected to continue long term. For safety, mortality was zero, indicating SMOFlipid is safe to use in this population.
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    [VIRTUAL] Impact of parenteral lipid formulation on incidence of essential fatty acid deficiency in pediatrics with intestinal failure () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_2179;    
    Recently, two emulsions, mixed-composite (SMOFlipid) and fish oil (Omegaven), became available...A total of 133 fatty acid profile measurements will be collected to achieve a power of 80% with alpha = 0.05 and effect size = 0.3. All outcomes will be analyzed via Chi-square test except fatty acid parameter comparisons, which will be completed via one-way ANOVA followed by post-hoc student t-test.
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    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.
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    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.
  • ||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
    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.