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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

TypeNameDescription
OTHERSMOFlipid 20%Fish oil-enriched intravenous lipid emulsion
OTHERLipofundin 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.