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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336908
• Other study ID #: 2030001 71860000074
• Secondary ID: UofA-JVA-2005-1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 13, 2006
• Last updated: November 26, 2007
• Start date: November 2005
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgical Procedures
• Inflammation

Intervention

Drug:
• a combination of MCT, LCT , and Fish Oil

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Stollery Children's Hospital Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether incidence of sepsis and degree of inflammatory response is altered
Secondary	To characterize serum arachidonic acid and eicosapentaenoic acid levels, leukotriene B 4/leukotriene B 5 levels and incidence of nosocomial infection
Secondary	To characterize incidental findings as a result of attaining complete fatty acid and cytokine profiles