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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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. |
doi_str_mv | 10.1097/MPG.0b013e3181de210c |
format | Article |
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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.</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 & 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</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&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 < 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.</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 & 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 & dosage</subject><subject>Plant Oils - therapeutic use</subject><subject>Pregnancy. Fetus. Placenta</subject><subject>premature birth</subject><subject>Soybean Oil - administration & dosage</subject><subject>Soybean Oil - therapeutic use</subject><subject>Thinness - drug therapy</subject><subject>Treatment Outcome</subject><subject>Triglycerides - administration & 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 & 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 & 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 & dosage</topic><topic>Plant Oils - therapeutic use</topic><topic>Pregnancy. Fetus. Placenta</topic><topic>premature birth</topic><topic>Soybean Oil - administration & dosage</topic><topic>Soybean Oil - therapeutic use</topic><topic>Thinness - drug therapy</topic><topic>Treatment Outcome</topic><topic>Triglycerides - administration & 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 < 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.</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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source | MEDLINE; Journals@Ovid Complete; Access via Wiley Online Library |
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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