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.

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Other: SMOFlipid 20%; Other: Lipofundin 20%

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Surabaya, Indonesia
    • Dr. Soetomo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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)

Collaborators and Investigators

• Sponsor: Dr. Soetomo General Hospital
• Investigators: Principal Investigator: Meta H Hanindita, Dr. Soetomo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Actual): July 13, 2020
• Study Completion (Actual): July 13, 2020

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Parenteral nutrition; Interleukin-8; Interleukin-1b; Lipid emulsion
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; SMOFlipid
• Other Study ID Numbers: 1983/105/II/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No