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

This study has been completed.
Sponsor:
Collaborator:
Stollery Children's Hospital Foundation
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00336908
First received: June 13, 2006
Last updated: November 26, 2007
Last verified: November 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Alberta

Additional 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
Study First Received: June 13, 2006
Last Updated: November 26, 2007
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014