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

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Other: Lipofundin 20%; Other: SMOFlipid 20%

• Registration Number: NCT04511299
• Lead Sponsor: Dr. Soetomo General Hospital

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.

Study Timeline

• Study Start: 2020-04-07
• Primary Completion: 2020-07-13
• Study Completion: 2020-07-13
• Status Verified: 2020-08
• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-10
• Last Update Submitted: 2020-08-10
• Study First Posted: 2020-08-13
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard intavenous lipid emulsion	Lipofundin 20%	Lipofundin 20%, given for 3 consecutive days with 1-4 g/kg/day.
Fish oil-enriched intravenous lipid emulsion	SMOFlipid 20%	SMOFlipid 20%, given for 3 consecutive days with 1-4 g/kg/day.

Primary Outcome Measures

Name	Time	Method
Fatty Acids Composition	3 days (before surgery and after surgery)	The percentage of fatty acid consentration from total fatty acids
Inflammatory response	3 days (before surgery and after surgery)	Interleukin 1b and Interleukin 8 levels

Secondary Outcome Measures

Name	Time	Method
C reactive Protein	3 days (before surgery and after surgery)	C Reactive Protein valuel in all subjects
Albumin	3 days (before surgery and after surgery)	Albumin value in all subjects
Hemoglobin	3 days (before surgery and after surgery)	Hemoglobin value in all subjects
Leukocyte	3 days (before surgery and after surgery)	Leukocyte value in all subjects

Trial Locations

Locations (1)

Dr. Soetomo General Hospital; 🇮🇩 Surabaya, Indonesia