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

NCT ID: NCT04511299

Last Updated: 2020-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-07

Study Completion Date

2020-07-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Fish oil-enriched intravenous lipid emulsion

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

Group Type EXPERIMENTAL

SMOFlipid 20%

Intervention Type OTHER

Fish oil-enriched intravenous lipid emulsion

Standard intavenous lipid emulsion

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

Group Type ACTIVE_COMPARATOR

Lipofundin 20%

Intervention Type OTHER

MCT/LCT standard intravenous lipid emulsion

Interventions

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SMOFlipid 20%

Fish oil-enriched intravenous lipid emulsion

Intervention Type OTHER

Lipofundin 20%

MCT/LCT standard intravenous lipid emulsion

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Soetomo General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Meta Herdiana Hanindita, dr., Sp.A (K)

MD, Pediatrician (Consultant)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meta H Hanindita

Role: PRINCIPAL_INVESTIGATOR

Dr. Soetomo General Hospital

Locations

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Dr. Soetomo General Hospital

Surabaya, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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1983/105/II/2020

Identifier Type: -

Identifier Source: org_study_id

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