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CompletedNCT00336908Updated Nov 27, 2007

Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery

A Phase 2/3 interventional study of a combination of MCT, LCT , and Fish Oil in Inflammation and Cardiac Surgical Procedures, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2007-11-27.

Sponsored by University of Alberta · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
Up to 3 Months
Sex
All
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Study summary

This study is a blinded, randomized, controlled prospective trial comparing immune response (sepsis, inflammatory response, pulmonary vasoconstriction) in 2 groups of infants less than 3-month old receiving pre and post cardiopulmonary bypass surgery. The infants will receive 1 out of the 2 following intravenous lipid preparations: Soybean Oil (n-6), or a combination of Medium Chain Triglyceride i.e. coconut oil, Long Chain Triglyceride i.e. Soybean Oil, and Fish Oil (MCT:LCT:FO). There will be 16 subjects in each group.

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Conditions studied

  • Inflammation
  • Cardiac Surgical Procedures

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Keywords

  • Intensive Care,Neonatal
  • Parenteral nutrition
  • Fat emulsions,Intravenous
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In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's planned enrollment of 32 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

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Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 3 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 36 weeks gestation
  • 3 months corrected age
  • appropriate for gestational age (AGA)
  • admitted for surgical correction of congenital heart defects (single ventricle, tetralogy of Fallot, truncus and complex biventricular repairs)
  • enteral nutrition at 30 kcal/kilogram/day

Exclusion criteria

Exclusion Criteria:

  • 5 minute Apgar score of 4
  • major congenital defect other than heart defect
  • presence of significant neonatal morbidity (intraventricular hemorrhage (IVH) grade 3 or greater, necrotizing enterocolitis (NEC) and surgical abdomen)
  • any metabolic disorder
  • any endocrine disorder
  • medications which alter eicosanoid metabolism including indomethacin, acetylsalicylate (with exception of steroids which will be analyzed independently)
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
32 participants (estimated)

Interventions

  • Druga combination of MCT, LCT , and Fish Oil
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What researchers measure

Primary outcomes

  1. To determine whether incidence of sepsis and degree of inflammatory response is altered

Secondary outcomes

  1. To characterize serum arachidonic acid and eicosapentaenoic acid levels, leukotriene B 4/leukotriene B 5 levels and incidence of nosocomial infection

  2. To characterize incidental findings as a result of attaining complete fatty acid and cytokine profiles

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Study locations

1 site
  • Stollery Children's Hospital
    Edmonton, Alberta T6G 2B7, Canada
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References and documents

Publications

  • Larsen BM, Goonewardene LA, Joffe AR, Van Aerde JE, Field CJ, Olstad DL, Clandinin MT. Pre-treatment with an intravenous lipid emulsion containing fish oil (eicosapentaenoic and docosahexaenoic acid) decreases inflammatory markers after open-heart surgery in infants: a randomized, controlled trial. Clin Nutr. 2012 Jun;31(3):322-9. doi: 10.1016/j.clnu.2011.11.006. Epub 2011 Dec 3. PubMed 22136963 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00336908
Lead sponsor
University of Alberta
Collaborators
Stollery Children's Hospital Foundation
First posted
Jun 14, 2006
Start date
Nov 2005
Completion
Nov 2007
Last update
Nov 27, 2007

Study contacts

John E Van Aerde, MD, PhD
principal investigator · University of Alberta
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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