Safety and Efficacy of a Lipid Emulsion Containing a Mixture of Soybean Oil, Medium‐chain Triglycerides, Olive Oil, and Fish Oil: A Randomised, Double‐blind Clinical Trial in Premature Infants Requiring Parenteral Nutrition

ABSTRACT Objectives: Safety, tolerability, and efficacy of a novel lipid emulsion containing a mixture of soybean oil, medium‐chain triglycerides, olive oil, and fish oil (SMOFlipid 20%) with reduced n‐6 fatty acids (FA), increased monounsaturated and n‐3 FA, and enriched in vitamin E were evaluated...

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Veröffentlicht in:Journal of pediatric gastroenterology and nutrition 2010-10, Vol.51 (4), p.514-521
Hauptverfasser: Tomsits, Erika, Pataki, Margit, Tölgyesi, Andrea, Fekete, György, Rischak, Katalin, Szollár, Lajos
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container_issue 4
container_start_page 514
container_title Journal of pediatric gastroenterology and nutrition
container_volume 51
creator Tomsits, Erika
Pataki, Margit
Tölgyesi, Andrea
Fekete, György
Rischak, Katalin
Szollár, Lajos
description ABSTRACT Objectives: Safety, tolerability, and efficacy of a novel lipid emulsion containing a mixture of soybean oil, medium‐chain triglycerides, olive oil, and fish oil (SMOFlipid 20%) with reduced n‐6 fatty acids (FA), increased monounsaturated and n‐3 FA, and enriched in vitamin E were evaluated in premature infants compared with a soybean oil–based emulsion. Patients and Methods: Sixty (30/30) premature neonates (age 3–7 days, gestational age ≤34 weeks, birth weights 1000–2500 g) received parenteral nutrition (PN) with either SMOFlipid 20% (study group) or a conventional lipid emulsion (Intralipid 20%, control group) for a minimum of 7 up to 14 days. Lipid supply started at 0.5 g · kg body weight−1 · day−1 on day 1 and increased stepwise (by 0.5 g) up to 2 g · kg body weight−1 · day−1 on days 4 to 14. Safety and efficacy parameters were assessed on days 0, 8, and 15 if PN was continued. Results: Adverse events, serum triglycerides, vital signs, local tolerance, and clinical laboratory did not show noticeable group differences, confirming the safety of study treatment. At study end, γ‐glutamyl transferase was lower in the study versus the control group (107.8 ± 81.7 vs 188.8 ± 176.7 IU/L, P < 0.05). The relative increase in body weight (day 8 vs baseline) was 5.0% ± 6.5% versus 5.1% ± 6.6% (study vs control, not significant). In the study group, an increase in n‐3 FA in red blood cell phospholipids and n‐3:n‐6 FA ratio was observed. Plasma α‐tocopherol (study vs control) was increased versus baseline on day 8 (26.35 ± 10.03 vs 3.67 ± 8.06 μmol/L, P < 0.05) and at study termination (26.97 ± 18.32 vs 8.73 ± 11.41 μmol/L, P < 0.05). Conclusions: Parenteral infusion of SMOFlipid was safe and well tolerated and showed a potential beneficial influence on cholestasis, n‐3 FA, and vitamin E status in premature infants requiring PN.
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Patients and Methods: Sixty (30/30) premature neonates (age 3–7 days, gestational age ≤34 weeks, birth weights 1000–2500 g) received parenteral nutrition (PN) with either SMOFlipid 20% (study group) or a conventional lipid emulsion (Intralipid 20%, control group) for a minimum of 7 up to 14 days. Lipid supply started at 0.5 g · kg body weight−1 · day−1 on day 1 and increased stepwise (by 0.5 g) up to 2 g · kg body weight−1 · day−1 on days 4 to 14. Safety and efficacy parameters were assessed on days 0, 8, and 15 if PN was continued. Results: Adverse events, serum triglycerides, vital signs, local tolerance, and clinical laboratory did not show noticeable group differences, confirming the safety of study treatment. At study end, γ‐glutamyl transferase was lower in the study versus the control group (107.8 ± 81.7 vs 188.8 ± 176.7 IU/L, P &lt; 0.05). The relative increase in body weight (day 8 vs baseline) was 5.0% ± 6.5% versus 5.1% ± 6.6% (study vs control, not significant). In the study group, an increase in n‐3 FA in red blood cell phospholipids and n‐3:n‐6 FA ratio was observed. Plasma α‐tocopherol (study vs control) was increased versus baseline on day 8 (26.35 ± 10.03 vs 3.67 ± 8.06 μmol/L, P &lt; 0.05) and at study termination (26.97 ± 18.32 vs 8.73 ± 11.41 μmol/L, P &lt; 0.05). Conclusions: Parenteral infusion of SMOFlipid was safe and well tolerated and showed a potential beneficial influence on cholestasis, n‐3 FA, and vitamin E status in premature infants requiring PN.</description><identifier>ISSN: 0277-2116</identifier><identifier>EISSN: 1536-4801</identifier><identifier>DOI: 10.1097/MPG.0b013e3181de210c</identifier><identifier>PMID: 20531018</identifier><identifier>CODEN: JPGND6</identifier><language>eng</language><publisher>Hagerstown, MD: Copyright by ESPGHAN and NASPGHAN</publisher><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Biological and medical sciences ; Body Weight - drug effects ; Diseases of mother, fetus and pregnancy ; Double-Blind Method ; Emergency and intensive care: metabolism and nutrition disorders. Enteral and parenteral nutrition ; Fat Emulsions, Intravenous - adverse effects ; Fat Emulsions, Intravenous - therapeutic use ; Feeding. Feeding behavior ; fish oil ; Fish Oils - administration &amp; dosage ; Fish Oils - therapeutic use ; Fundamental and applied biological sciences. Psychology ; Gynecology. Andrology. Obstetrics ; Humans ; Infant Nutritional Physiological Phenomena ; Infant, Newborn ; Infant, Premature ; Intensive care medicine ; lipids ; Medical sciences ; Olive Oil ; parenteral nutrition ; Parenteral Nutrition - methods ; Plant Oils - administration &amp; dosage ; Plant Oils - therapeutic use ; Pregnancy. Fetus. Placenta ; premature birth ; Soybean Oil - administration &amp; dosage ; Soybean Oil - therapeutic use ; Thinness - drug therapy ; Treatment Outcome ; Triglycerides - administration &amp; dosage ; Triglycerides - therapeutic use ; Vertebrates: anatomy and physiology, studies on body, several organs or systems ; vitamin E ; Weight Gain - drug effects</subject><ispartof>Journal of pediatric gastroenterology and nutrition, 2010-10, Vol.51 (4), p.514-521</ispartof><rights>2010 by European Society for European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition</rights><rights>Copyright 2010 by ESPGHAN and NASPGHAN</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c510c-b1e018251454161ef34d5af82bc2b51b3d0accb5f38370c4c15eafb4dc0082303</citedby><cites>FETCH-LOGICAL-c510c-b1e018251454161ef34d5af82bc2b51b3d0accb5f38370c4c15eafb4dc0082303</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1097%2FMPG.0b013e3181de210c$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1097%2FMPG.0b013e3181de210c$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=23253346$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20531018$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tomsits, Erika</creatorcontrib><creatorcontrib>Pataki, Margit</creatorcontrib><creatorcontrib>Tölgyesi, Andrea</creatorcontrib><creatorcontrib>Fekete, György</creatorcontrib><creatorcontrib>Rischak, Katalin</creatorcontrib><creatorcontrib>Szollár, Lajos</creatorcontrib><title>Safety and Efficacy of a Lipid Emulsion Containing a Mixture of Soybean Oil, Medium‐chain Triglycerides, Olive Oil, and Fish Oil: A Randomised, Double‐blind Clinical Trial in Premature Infants Requiring Parenteral Nutrition</title><title>Journal of pediatric gastroenterology and nutrition</title><addtitle>J Pediatr Gastroenterol Nutr</addtitle><description>ABSTRACT Objectives: Safety, tolerability, and efficacy of a novel lipid emulsion containing a mixture of soybean oil, medium‐chain triglycerides, olive oil, and fish oil (SMOFlipid 20%) with reduced n‐6 fatty acids (FA), increased monounsaturated and n‐3 FA, and enriched in vitamin E were evaluated in premature infants compared with a soybean oil–based emulsion. Patients and Methods: Sixty (30/30) premature neonates (age 3–7 days, gestational age ≤34 weeks, birth weights 1000–2500 g) received parenteral nutrition (PN) with either SMOFlipid 20% (study group) or a conventional lipid emulsion (Intralipid 20%, control group) for a minimum of 7 up to 14 days. Lipid supply started at 0.5 g · kg body weight−1 · day−1 on day 1 and increased stepwise (by 0.5 g) up to 2 g · kg body weight−1 · day−1 on days 4 to 14. Safety and efficacy parameters were assessed on days 0, 8, and 15 if PN was continued. Results: Adverse events, serum triglycerides, vital signs, local tolerance, and clinical laboratory did not show noticeable group differences, confirming the safety of study treatment. At study end, γ‐glutamyl transferase was lower in the study versus the control group (107.8 ± 81.7 vs 188.8 ± 176.7 IU/L, P &lt; 0.05). The relative increase in body weight (day 8 vs baseline) was 5.0% ± 6.5% versus 5.1% ± 6.6% (study vs control, not significant). In the study group, an increase in n‐3 FA in red blood cell phospholipids and n‐3:n‐6 FA ratio was observed. Plasma α‐tocopherol (study vs control) was increased versus baseline on day 8 (26.35 ± 10.03 vs 3.67 ± 8.06 μmol/L, P &lt; 0.05) and at study termination (26.97 ± 18.32 vs 8.73 ± 11.41 μmol/L, P &lt; 0.05). Conclusions: Parenteral infusion of SMOFlipid was safe and well tolerated and showed a potential beneficial influence on cholestasis, n‐3 FA, and vitamin E status in premature infants requiring PN.</description><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Biological and medical sciences</subject><subject>Body Weight - drug effects</subject><subject>Diseases of mother, fetus and pregnancy</subject><subject>Double-Blind Method</subject><subject>Emergency and intensive care: metabolism and nutrition disorders. Enteral and parenteral nutrition</subject><subject>Fat Emulsions, Intravenous - adverse effects</subject><subject>Fat Emulsions, Intravenous - therapeutic use</subject><subject>Feeding. Feeding behavior</subject><subject>fish oil</subject><subject>Fish Oils - administration &amp; dosage</subject><subject>Fish Oils - therapeutic use</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Infant Nutritional Physiological Phenomena</subject><subject>Infant, Newborn</subject><subject>Infant, Premature</subject><subject>Intensive care medicine</subject><subject>lipids</subject><subject>Medical sciences</subject><subject>Olive Oil</subject><subject>parenteral nutrition</subject><subject>Parenteral Nutrition - methods</subject><subject>Plant Oils - administration &amp; dosage</subject><subject>Plant Oils - therapeutic use</subject><subject>Pregnancy. Fetus. Placenta</subject><subject>premature birth</subject><subject>Soybean Oil - administration &amp; dosage</subject><subject>Soybean Oil - therapeutic use</subject><subject>Thinness - drug therapy</subject><subject>Treatment Outcome</subject><subject>Triglycerides - administration &amp; dosage</subject><subject>Triglycerides - therapeutic use</subject><subject>Vertebrates: anatomy and physiology, studies on body, several organs or systems</subject><subject>vitamin E</subject><subject>Weight Gain - drug effects</subject><issn>0277-2116</issn><issn>1536-4801</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkc9uEzEQxlcIREPhDRDyBXFJiv-sswsShxKaUpQ0UVvOK9s7bgze3dTepeyNR-AZ4UWYJQEkLnCx5fFvvvlmJkkeM3rE6Ivs-XJ9ekQ1ZQIEy1kJnFFzJxkxKaaTNKfsbjKiPMsmnLHpQfIgxg-U0iyV9H5ywKkUjLJ8lHy_VBbanqi6JCfWOqNMTxpLFFm4rcNY1fnomprMmrpVrnb1Nf4t3ee2CzCAl02vQdVk5fyYLKF0XfXty1ezQZZcBXftewPBlRDHZOXdJ9iBQ7m5i5vh9ZIckwsMNJWLUI7Jm6bTHlBEe4fYDE-05Qc1PFF2HaBSP-uf1VbVbSQXcNO5MHhbqwB1CwHJ864NrkXvD5N7VvkIj_b3YfJ-fnI1eztZrE7PZseLiZE4u4lmgCPhkqUyZVMGVqSlVDbn2nAtmRYlVcZoaUUuMmpSwyQoq9PSUJpzQcVh8mynuw3NTQexLbAjA96rGpouFpmUKeWcMyTTHWlCE2MAW2yDq1ToC0aLYbsFbrf4e7uY9mRfoNMVlL-Tfq0Tgad7QEUcmQ2qNi7-4QSXQqRT5PIdd9t4HFb86LtbCMUGlG83__Lwap_qPPT_5bt4tz4Xr-cU22fiBxLC16c</recordid><startdate>201010</startdate><enddate>201010</enddate><creator>Tomsits, Erika</creator><creator>Pataki, Margit</creator><creator>Tölgyesi, Andrea</creator><creator>Fekete, György</creator><creator>Rischak, Katalin</creator><creator>Szollár, Lajos</creator><general>Copyright by ESPGHAN and NASPGHAN</general><general>Lippincott Williams &amp; Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201010</creationdate><title>Safety and Efficacy of a Lipid Emulsion Containing a Mixture of Soybean Oil, Medium‐chain Triglycerides, Olive Oil, and Fish Oil: A Randomised, Double‐blind Clinical Trial in Premature Infants Requiring Parenteral Nutrition</title><author>Tomsits, Erika ; Pataki, Margit ; Tölgyesi, Andrea ; Fekete, György ; Rischak, Katalin ; Szollár, Lajos</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c510c-b1e018251454161ef34d5af82bc2b51b3d0accb5f38370c4c15eafb4dc0082303</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Biological and medical sciences</topic><topic>Body Weight - drug effects</topic><topic>Diseases of mother, fetus and pregnancy</topic><topic>Double-Blind Method</topic><topic>Emergency and intensive care: metabolism and nutrition disorders. Enteral and parenteral nutrition</topic><topic>Fat Emulsions, Intravenous - adverse effects</topic><topic>Fat Emulsions, Intravenous - therapeutic use</topic><topic>Feeding. Feeding behavior</topic><topic>fish oil</topic><topic>Fish Oils - administration &amp; dosage</topic><topic>Fish Oils - therapeutic use</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Infant Nutritional Physiological Phenomena</topic><topic>Infant, Newborn</topic><topic>Infant, Premature</topic><topic>Intensive care medicine</topic><topic>lipids</topic><topic>Medical sciences</topic><topic>Olive Oil</topic><topic>parenteral nutrition</topic><topic>Parenteral Nutrition - methods</topic><topic>Plant Oils - administration &amp; dosage</topic><topic>Plant Oils - therapeutic use</topic><topic>Pregnancy. Fetus. Placenta</topic><topic>premature birth</topic><topic>Soybean Oil - administration &amp; dosage</topic><topic>Soybean Oil - therapeutic use</topic><topic>Thinness - drug therapy</topic><topic>Treatment Outcome</topic><topic>Triglycerides - administration &amp; dosage</topic><topic>Triglycerides - therapeutic use</topic><topic>Vertebrates: anatomy and physiology, studies on body, several organs or systems</topic><topic>vitamin E</topic><topic>Weight Gain - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tomsits, Erika</creatorcontrib><creatorcontrib>Pataki, Margit</creatorcontrib><creatorcontrib>Tölgyesi, Andrea</creatorcontrib><creatorcontrib>Fekete, György</creatorcontrib><creatorcontrib>Rischak, Katalin</creatorcontrib><creatorcontrib>Szollár, Lajos</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of pediatric gastroenterology and nutrition</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tomsits, Erika</au><au>Pataki, Margit</au><au>Tölgyesi, Andrea</au><au>Fekete, György</au><au>Rischak, Katalin</au><au>Szollár, Lajos</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and Efficacy of a Lipid Emulsion Containing a Mixture of Soybean Oil, Medium‐chain Triglycerides, Olive Oil, and Fish Oil: A Randomised, Double‐blind Clinical Trial in Premature Infants Requiring Parenteral Nutrition</atitle><jtitle>Journal of pediatric gastroenterology and nutrition</jtitle><addtitle>J Pediatr Gastroenterol Nutr</addtitle><date>2010-10</date><risdate>2010</risdate><volume>51</volume><issue>4</issue><spage>514</spage><epage>521</epage><pages>514-521</pages><issn>0277-2116</issn><eissn>1536-4801</eissn><coden>JPGND6</coden><abstract>ABSTRACT Objectives: Safety, tolerability, and efficacy of a novel lipid emulsion containing a mixture of soybean oil, medium‐chain triglycerides, olive oil, and fish oil (SMOFlipid 20%) with reduced n‐6 fatty acids (FA), increased monounsaturated and n‐3 FA, and enriched in vitamin E were evaluated in premature infants compared with a soybean oil–based emulsion. Patients and Methods: Sixty (30/30) premature neonates (age 3–7 days, gestational age ≤34 weeks, birth weights 1000–2500 g) received parenteral nutrition (PN) with either SMOFlipid 20% (study group) or a conventional lipid emulsion (Intralipid 20%, control group) for a minimum of 7 up to 14 days. Lipid supply started at 0.5 g · kg body weight−1 · day−1 on day 1 and increased stepwise (by 0.5 g) up to 2 g · kg body weight−1 · day−1 on days 4 to 14. Safety and efficacy parameters were assessed on days 0, 8, and 15 if PN was continued. Results: Adverse events, serum triglycerides, vital signs, local tolerance, and clinical laboratory did not show noticeable group differences, confirming the safety of study treatment. At study end, γ‐glutamyl transferase was lower in the study versus the control group (107.8 ± 81.7 vs 188.8 ± 176.7 IU/L, P &lt; 0.05). The relative increase in body weight (day 8 vs baseline) was 5.0% ± 6.5% versus 5.1% ± 6.6% (study vs control, not significant). In the study group, an increase in n‐3 FA in red blood cell phospholipids and n‐3:n‐6 FA ratio was observed. Plasma α‐tocopherol (study vs control) was increased versus baseline on day 8 (26.35 ± 10.03 vs 3.67 ± 8.06 μmol/L, P &lt; 0.05) and at study termination (26.97 ± 18.32 vs 8.73 ± 11.41 μmol/L, P &lt; 0.05). Conclusions: Parenteral infusion of SMOFlipid was safe and well tolerated and showed a potential beneficial influence on cholestasis, n‐3 FA, and vitamin E status in premature infants requiring PN.</abstract><cop>Hagerstown, MD</cop><pub>Copyright by ESPGHAN and NASPGHAN</pub><pmid>20531018</pmid><doi>10.1097/MPG.0b013e3181de210c</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record>
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subjects Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Biological and medical sciences
Body Weight - drug effects
Diseases of mother, fetus and pregnancy
Double-Blind Method
Emergency and intensive care: metabolism and nutrition disorders. Enteral and parenteral nutrition
Fat Emulsions, Intravenous - adverse effects
Fat Emulsions, Intravenous - therapeutic use
Feeding. Feeding behavior
fish oil
Fish Oils - administration & dosage
Fish Oils - therapeutic use
Fundamental and applied biological sciences. Psychology
Gynecology. Andrology. Obstetrics
Humans
Infant Nutritional Physiological Phenomena
Infant, Newborn
Infant, Premature
Intensive care medicine
lipids
Medical sciences
Olive Oil
parenteral nutrition
Parenteral Nutrition - methods
Plant Oils - administration & dosage
Plant Oils - therapeutic use
Pregnancy. Fetus. Placenta
premature birth
Soybean Oil - administration & dosage
Soybean Oil - therapeutic use
Thinness - drug therapy
Treatment Outcome
Triglycerides - administration & dosage
Triglycerides - therapeutic use
Vertebrates: anatomy and physiology, studies on body, several organs or systems
vitamin E
Weight Gain - drug effects
title Safety and Efficacy of a Lipid Emulsion Containing a Mixture of Soybean Oil, Medium‐chain Triglycerides, Olive Oil, and Fish Oil: A Randomised, Double‐blind Clinical Trial in Premature Infants Requiring Parenteral Nutrition
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