NCT04511299

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 7, 2020

Last Update Submit

August 10, 2020

Conditions

Surgery

Keywords

Parenteral nutritionInterleukin-1bInterleukin-8Lipid emulsion

Outcome Measures

Primary Outcomes (2)

  • Fatty Acids Composition

    The percentage of fatty acid consentration from total fatty acids

    3 days (before surgery and after surgery)

  • Inflammatory response

    Interleukin 1b and Interleukin 8 levels

    3 days (before surgery and after surgery)

Secondary Outcomes (4)

  • Hemoglobin

    3 days (before surgery and after surgery)

  • Leukocyte

    3 days (before surgery and after surgery)

  • C reactive Protein

    3 days (before surgery and after surgery)

  • Albumin

    3 days (before surgery and after surgery)

Study Arms (2)

Fish oil-enriched intravenous lipid emulsion

EXPERIMENTAL

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

Other: SMOFlipid 20%

Standard intavenous lipid emulsion

ACTIVE COMPARATOR

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

Other: Lipofundin 20%

Interventions

SMOFlipid 20%OTHER

Fish oil-enriched intravenous lipid emulsion

Fish oil-enriched intravenous lipid emulsion
Lipofundin 20%OTHER

MCT/LCT standard intravenous lipid emulsion

Standard intavenous lipid emulsion

Eligibility Criteria

Age1 Hour - 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • willing to participate in this study (through informed consent)
  • undergo gastrointestinal surgery
  • get parenteral nutrition for at least 3 days

You may not qualify if:

  • chronic diseases
  • allergic to fish, egg, soy and/or nut proteins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Soetomo General Hospital

Surabaya, Indonesia

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Meta H Hanindita

    Dr. Soetomo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Pediatrician (Consultant)

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 13, 2020

Study Start

April 7, 2020

Primary Completion

July 13, 2020

Study Completion

July 13, 2020

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)