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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00336908
Recruitment Status : Completed
First Posted : June 14, 2006
Last Update Posted : November 27, 2007
Stollery Children's Hospital Foundation
Information provided by:
University of Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Inflammation Cardiac Surgical Procedures Drug: a combination of MCT, LCT , and Fish Oil Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Inflammatory Responses of Intravenous Fish Oil, Soybean Oil and Medium Chain Triglyceride Fat Emulsions in Young Children Before and After Open Heart Surgery
Study Start Date : November 2005
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Fish oil
U.S. FDA Resources

Primary Outcome Measures :
  1. To determine whether incidence of sepsis and degree of inflammatory response is altered

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00336908

Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Stollery Children's Hospital Foundation
Principal Investigator: John E Van Aerde, MD, PhD University of Alberta

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00336908     History of Changes
Other Study ID Numbers: 2030001 71860000074
First Posted: June 14, 2006    Key Record Dates
Last Update Posted: November 27, 2007
Last Verified: November 2007

Keywords provided by University of Alberta:
Intensive Care,Neonatal
Parenteral nutrition
Fat emulsions,Intravenous

Additional relevant MeSH terms:
Pathologic Processes