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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04511299
Other study ID # 1983/105/II/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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