Trials / Completed
CompletedNCT04511299
Impact of Fish Oil-enriched Lipid Emulsion on Fatty Acid and Inflammatory Response in Infants After Surgery
Impact of Fish Oil-enriched Intravenous Lipid Emulsion in Parenteral Nutrition of Phospholipid Fatty Acid Composition and Inflammatory Response in Infants After Gastrointestinal Surgery.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Dr. Soetomo General Hospital · Other Government
- Sex
- All
- Age
- 1 Hour – 2 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | SMOFlipid 20% | Fish oil-enriched intravenous lipid emulsion |
| OTHER | Lipofundin 20% | MCT/LCT standard intravenous lipid emulsion |
Timeline
- Start date
- 2020-04-07
- Primary completion
- 2020-07-13
- Completion
- 2020-07-13
- First posted
- 2020-08-13
- Last updated
- 2020-08-13
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT04511299. Inclusion in this directory is not an endorsement.