Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery - Full Text View

Sponsors and Collaborators:	University of Alberta Stollery Children's Hospital Foundation
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00336908

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 II Phase III

MedlinePlus related topics: Heart Surgery Sepsis

Drug Information available for: Fish oil Soybean oil Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Study ID Numbers:	2030001 71860000074, UofA-JVA-2005-1
Study First Received:	June 13, 2006
Last Updated:	November 26, 2007
ClinicalTrials.gov Identifier:	NCT00336908
Health Authority:	Canada: Health Canada

Keywords provided by University of Alberta:

Intensive Care,Neonatal
Parenteral nutrition
Fat emulsions,Intravenous

Study placed in the following topic categories:

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009