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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00336908
First Posted: June 14, 2006
Last Update Posted: November 27, 2007
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.
Collaborator:
Stollery Children's Hospital Foundation
Information provided by:
University of Alberta
  Purpose
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 Intervention Phase
Inflammation Cardiac Surgical Procedures Drug: a combination of MCT, LCT , and Fish Oil Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

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

Secondary Outcome Measures:
  • To characterize serum arachidonic acid and eicosapentaenoic acid levels, leukotriene B 4/leukotriene B 5 levels and incidence of nosocomial infection
  • To characterize incidental findings as a result of attaining complete fatty acid and cytokine profiles

Estimated Enrollment: 32
Study Start Date: November 2005
Study Completion Date: November 2007
  Eligibility

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
Criteria

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00336908


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00336908     History of Changes
Other Study ID Numbers: 2030001 71860000074
UofA-JVA-2005-1
First Submitted: June 13, 2006
First Posted: June 14, 2006
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:
Inflammation
Pathologic Processes