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

Primary Purpose

Inflammation, Cardiac Surgical Procedures

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

a combination of MCT, LCT , and Fish Oil

About this trial

This is an interventional treatment trial for Inflammation focused on measuring Intensive Care,Neonatal, Parenteral nutrition, Fat emulsions,Intravenous

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Stollery Children's Hospital

Outcomes

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

Full Information

NCT ID

NCT00336908

First Posted

June 13, 2006

Last Updated

November 26, 2007

Sponsor

University of Alberta

Collaborators

Stollery Children's Hospital Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00336908

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Alberta

Collaborators

Stollery Children's Hospital Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Cardiac Surgical Procedures

Keywords

Intensive Care,Neonatal, Parenteral nutrition, Fat emulsions,Intravenous

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

a combination of MCT, LCT , and Fish Oil

Primary Outcome Measure Information:

Title

To determine whether incidence of sepsis and degree of inflammatory response is altered

Secondary Outcome Measure Information:

Title

To characterize serum arachidonic acid and eicosapentaenoic acid levels, leukotriene B 4/leukotriene B 5 levels and incidence of nosocomial infection

Title

To characterize incidental findings as a result of attaining complete fatty acid and cytokine profiles

10. Eligibility

Sex

All

Maximum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John E Van Aerde, MD, PhD

Organizational Affiliation

University of Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stollery Children's Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

22136963

Citation

Larsen BM, Goonewardene LA, Joffe AR, Van Aerde JE, Field CJ, Olstad DL, Clandinin MT. Pre-treatment with an intravenous lipid emulsion containing fish oil (eicosapentaenoic and docosahexaenoic acid) decreases inflammatory markers after open-heart surgery in infants: a randomized, controlled trial. Clin Nutr. 2012 Jun;31(3):322-9. doi: 10.1016/j.clnu.2011.11.006. Epub 2011 Dec 3.

Results Reference

derived

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

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