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Completed

NCT Number: NCT04511299

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

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Key information

Conditions

Surgery Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 hour–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Soetomo General Hospital

Surabaya, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMOFlipid 20%

Other

Fish oil-enriched intravenous lipid emulsion

Lipofundin 20%

Other

MCT/LCT standard intravenous lipid emulsion

Primary outcomes

  1. Fatty Acids Composition

    Time frame: 3 days (before surgery and after surgery)

    The percentage of fatty acid consentration from total fatty acids

  2. Inflammatory response

    Time frame: 3 days (before surgery and after surgery)

    Interleukin 1b and Interleukin 8 levels

Secondary outcomes

  1. Hemoglobin

    Time frame: 3 days (before surgery and after surgery)

    Hemoglobin value in all subjects

  2. Leukocyte

    Time frame: 3 days (before surgery and after surgery)

    Leukocyte value in all subjects

  3. C reactive Protein

    Time frame: 3 days (before surgery and after surgery)

    C Reactive Protein valuel in all subjects

  4. Albumin

    Time frame: 3 days (before surgery and after surgery)

    Albumin value in all subjects

Sponsors and collaborators

Lead sponsor

Dr. Soetomo General Hospital

Other Gov

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2020
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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