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

Surgery Clinical Trial

Official title:

Impact of Fish Oil-enriched Intravenous Lipid Emulsion in Parenteral Nutrition of Phospholipid Fatty Acid Composition and Inflammatory Response in Infants After Gastrointestinal Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511299
• Other study ID #: 1983/105/II/2020
• Status: Completed
• Phase: N/A
• Start date: April 7, 2020
• Est. completion date: July 13, 2020

Study information

• Verified date: August 2020
• Source: Dr. Soetomo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 13, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• SMOFlipid 20%
Fish oil-enriched intravenous lipid emulsion
• Lipofundin 20%
MCT/LCT standard intravenous lipid emulsion

Locations

Country	Name	City	State
Indonesia	Dr. Soetomo General Hospital	Surabaya

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Soetomo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatty Acids Composition	The percentage of fatty acid consentration from total fatty acids	3 days (before surgery and after surgery)
Primary	Inflammatory response	Interleukin 1b and Interleukin 8 levels	3 days (before surgery and after surgery)
Secondary	Hemoglobin	Hemoglobin value in all subjects	3 days (before surgery and after surgery)
Secondary	Leukocyte	Leukocyte value in all subjects	3 days (before surgery and after surgery)
Secondary	C reactive Protein	C Reactive Protein valuel in all subjects	3 days (before surgery and after surgery)
Secondary	Albumin	Albumin value in all subjects	3 days (before surgery and after surgery)