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

Phase 2

Completed

• Conditions: Inflammation; Cardiac Surgical Procedures

• Registration Number: NCT00336908
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-06-13
• Study First Submitted QC: 2006-06-13
• Study First Posted: 2006-06-14
• Status Verified: 2007-11
• Study Completion: 2007-11
• Last Update Submitted: 2007-11-26
• Last Update Posted: 2007-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada