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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014