TITLE: Comparison of Two Fat Emulsions on Interleukin-1β, Interleukin-8 and Fatty Acid Composition  in Infants Post Gastrointestinal Surgery:  A Randomized Trial  Protocol
AUTHORS: Meta Herdiana Hanindita

[DESCRIPTION]
<div class = "text-blocks"><div class = "text-block"><div class = "justify" style = "text-align:left"><span>Surgical intervention in infants is associated with postoperative sepsis and severe outcomes due to immature immune system</span><span style = "vertical-align:super;">1</span><span>. Gastrointestinal surgery induces excessive cytokine secretion, which may lead to increased postoperative mortality and morbidity</span><span style = "vertical-align:super;">2</span><span>. </span></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"><span>Parenteral nutrition plays a crucial role in pediatric patients who undergo gastrointestinal surgery</span><span style = "vertical-align:super;">3</span><span>. Intravenous lipid emulsion is an integral part of parenteral nutrition because it contains high energy density and low osmolarity, hence becoming the main source of energy and essential fatty acids</span><span style = "vertical-align:super;">4,5</span><span>. Fatty acid determines structural integrity and fluidity of cell membrane, and it has been proven that fatty acid helps to regulate expression of various genes and modulate cell-signaling pathway, which occurs during inflammation</span><span style = "vertical-align:super;">6,7</span><span>. </span></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"><span>The current standard type of IVFE is a 50:50 mixture of medium chain triglyceride (MCT) and long chain triglyceride (LCT)</span><span style = "vertical-align:super;">8</span><span>. This type of emulsion is rich in ω-6 and contains high levels of linoleic acid (LA, C18:2 ω -6) and alpha-linolenic acid (ALA, C18:3 ω-3). According to several studies, ω-6 is associated with impaired cell-mediated immunity and higher potential risk of elevated proinflammatory markers and severe inflammatory response. This mechanisms may lead to the increase in mortality, morbidity, duration of treatment, and recovery time in patients who undergo gastrointestinal surgery</span><span style = "vertical-align:super;">9-11</span><span>.</span></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"><span>Calder (2010) showed that the structure modification of fatty acids may alter their functions7. Some studies have shown that the addition of ω-3 in soy oil-based fat emulsion may improve patients’ outcome by modulating inflammatory response</span><span style = "vertical-align:super;">3,4,12</span><span>. ω-3, particularly eicosapentaenoic acid (EPA) and doxohexanoic acid (DHA), is a competitive enzyme inhibitor of arachidonic acid (AA). ω-3 has potential anti-inflammatory properties by inhibiting AA pathway and generating inflammatory eicosanoids, such as prostaglandine E3, thromboxane A3 and leukotriene B5, which are considered less inflammatory. Up to this time, the effect of ω-3-enriched intravenous fat emulsion compared to standard intravenous fat emulsion on the IL-1b ,IL-8 levels and plasma fatty acid composition in infants who undergo gastrointestinal surgery has yet to be elucidated. </span></div></div><div class = "text-block"><div class = "justify" style = "text-align:left">The purpose of this study is aimed to investigate the effect of ω-3-enriched intravenous fat emulsion compared to standard intravenous fat emulsion on the IL-1b ,IL-8 levels and plasma fatty acid composition in infants who undergo gastrointestinal surgery</div></div><div class = "text-block"><div class = "justify" style = "text-align:left"></div></div><div class = "text-block"><div class = "justify" style = "text-align:left">Trial Design:</div></div><div class = "text-block"><div class = "justify" style = "text-align:left">Type: Parallel randomized controlled trial</div></div><div class = "text-block"><div class = "justify" style = "text-align:left">Allocation ratio:1:1</div></div><div class = "text-block"><div class = "justify" style = "text-align:left">Framework: Superiority</div></div><div class = "text-block"><div class = "justify" style = "text-align:left"></div></div><div class = "text-block"><div class = "justify" style = "text-align:left">Aim of the study:</div></div><div class = "text-block"><div class = "justify" style = "text-align:left">The purpose of this study is to investigate the effect of ω-3-enriched intravenous fat emulsion compared to standard MCT/LCT intravenous fat emulsion on the IL-1b ,IL-8 levels and plasma fatty acid composition in infants who undergo gastrointestinal surgery.</div></div><div class = "text-block"><div class = "justify" style = "text-align:left"></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"><span style = ":UNDERLINE;">PICO approach:</span></div></div><div class = "text-block"><div class = "justify" style = "text-align:left">P: Patients underwent gastrointestinal surgery. </div></div><div class = "text-block"><div class = "justify" style = "text-align:left">I: ω-3-enriched intravenous fat emulsion</div></div><div class = "text-block"><div class = "justify" style = "text-align:left">C: MCT/LCT standard intravenous fat emulsion</div></div><div class = "text-block"><div class = "justify" style = "text-align:left">O:</div></div><table border><tr style = "text-align:center;"><td>  </td><td>A</td><td>B</td><td>C</td><td>D</td></tr><tr><td style = "text-align:center;">1</td><td rowspan = "" colspan = "" style ="display : table-cell;">     </td><td rowspan = "" colspan = "" style ="display : table-cell;">  <b>Outcome
  measure</b>  </td><td rowspan = "" colspan = "" style ="display : table-cell;">  <b>Tool
  for measurement</b>  </td><td rowspan = "" colspan = "" style ="display : table-cell;">  <b>Unit
  of measurement</b>  </td></tr><tr><td style = "text-align:center;">2</td><td rowspan = "" colspan = "" style ="display : table-cell;">  Primary  </td><td rowspan = "" colspan = "" style ="display : table-cell;">  Inflammatory
  response IL-1  </td><td rowspan = "" colspan = "" style ="display : table-cell;">  Blood
    </td><td rowspan = "" colspan = "" style ="display : table-cell;">  pg/ml     </td></tr><tr><td style = "text-align:center;">3</td><td rowspan = "" colspan = "" style ="display : table-cell;">  &nbsp;  </td><td rowspan = "" colspan = "" style ="display : table-cell;">  Inflammatory
  response IL-8  </td><td rowspan = "" colspan = "" style ="display : table-cell;">  Blood     </td><td rowspan = "" colspan = "" style ="display : table-cell;">  Pg/ml  </td></tr><tr><td style = "text-align:center;">4</td><td rowspan = "" colspan = "" style ="display : table-cell;">  Secondary  </td><td rowspan = "" colspan = "" style ="display : table-cell;">  Fatty Acid composition  </td><td rowspan = "" colspan = "" style ="display : table-cell;">  Blood     </td><td rowspan = "" colspan = "" style ="display : table-cell;">  (%of Total fatty acids)  </td></tr></table><div class = "text-block"><div class = "justify" style = "text-align:left">S→ Randomized control study</div></div><div class = "text-block"><h1></h1></div><div class = "text-block"><div class = "justify" style = "text-align:left">Research Question</div></div><div class = "text-block"><div class = "justify" style = "text-align:left">Will the Intravenous omega-3 enriched-fat emulsion make difference in IL-1β, IL-8 and fatty acid composition when compared to standard intravenous MCT/LCT fat emulsion?</div></div><div class = "text-block"><div class = "justify" style = "text-align:left"></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"> </div></div></div>

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