Impact of Fish Oil-enriched Lipid Emulsion on Fatty Acid and Inflammatory Response in Infants After Surgery

Study Overview
=================
Brief Summary
-----------------
This study aim to compare the impact of fish oil-enriched intravenous lipid emulsion to standard Intravenous lipid emulsion on fatty acid composition and inflammatory response (IL-1β and IL-8 levels) in infants after gastrointestinal surgery. Our hypothesis is the fish oil-enriched intravenous lipid emulsion can improve the fatty acid composition and lower the inflammatory response.

Detailed Description
-----------------
This study is conducted in infants post gastrointestinal surgery that requires parenteral nutrition for at least 3 days. Subjects are classified into two groups. Group 1 received standard IVFE and group 2 received ω-3-enriched IVFE. The type of intravenous standard and omega-3-enriched fat emulsion used in this study are Lipofundin 20% and SMOFlipid 20%, respectively, both administered for three consecutive days after surgery (72 hours) in 1-4 gram/kilogram/day dosing. The inflammatory response (IL-1β and IL-8 levels) and fatty acid composition are checked from blood plasma. Blood examination is done before the surgery and 3 days after the surgery.

Official Title
-----------------
Impact of Fish Oil-enriched Intravenous Lipid Emulsion in Parenteral Nutrition of Phospholipid Fatty Acid Composition and Inflammatory Response in Infants After Gastrointestinal Surgery.

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Other: SMOFlipid 20%
* Other: Lipofundin 20%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to participate in this study (through informed consent) undergo gastrointestinal surgery get parenteral nutrition for at least 3 days Exclusion Criteria: chronic diseases allergic to fish, egg, soy and/or nut proteins

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 2 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil-enriched intravenous lipid emulsion<br>SMOFlipid 20%, given for 3 consecutive days with 1-4 g/kg/day. | Other: SMOFlipid 20%<br>* Fish oil-enriched intravenous lipid emulsion<br>|
| Active Comparator: Standard intavenous lipid emulsion<br>Lipofundin 20%, given for 3 consecutive days with 1-4 g/kg/day. | Other: Lipofundin 20%<br>* MCT/LCT standard intravenous lipid emulsion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatty Acids Composition | The percentage of fatty acid consentration from total fatty acids | 3 days (before surgery and after surgery) | 
| Inflammatory response | Interleukin 1b and Interleukin 8 levels | 3 days (before surgery and after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Hemoglobin value in all subjects | 3 days (before surgery and after surgery) | 
| Leukocyte | Leukocyte value in all subjects | 3 days (before surgery and after surgery) | 
| C reactive Protein | C Reactive Protein valuel in all subjects | 3 days (before surgery and after surgery) | 
| Albumin | Albumin value in all subjects | 3 days (before surgery and after surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parenteral nutrition, Interleukin-1b, Interleukin-8, Lipid emulsion