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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil-enriched intravenous lipid emulsion | Experimental | SMOFlipid 20%, given for 3 consecutive days with 1-4 g/kg/day. |
|
| Standard intavenous lipid emulsion | Active Comparator | Lipofundin 20%, given for 3 consecutive days with 1-4 g/kg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMOFlipid 20% | Other | Fish oil-enriched intravenous lipid emulsion |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meta H Hanindita | Dr. Soetomo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Soetomo General Hospital | Surabaya | Indonesia |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lipofundin 20% | Other | MCT/LCT standard intravenous lipid emulsion |
|
| 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) |