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

Dr. Soetomo General Hospital

Status: Completed

Conditions: Surgery

Treatments: Other: SMOFlipid 20%; Other: Lipofundin 20%

Study type: Interventional

Funder types: Other

Identifiers

NCT04511299

1983/105/II/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 1 hour to 2 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

Fish oil-enriched intravenous lipid emulsion

Experimental group

Description:

SMOFlipid 20%, given for 3 consecutive days with 1-4 g/kg/day.

Treatment:

Other: SMOFlipid 20%

Standard intavenous lipid emulsion

Active Comparator group

Description:

Lipofundin 20%, given for 3 consecutive days with 1-4 g/kg/day.

Treatment:

Other: Lipofundin 20%