NCT00336908CompletedPhase 2
Inflammatory Responses of Intravenous Fish Oil, Soybean Oil and Medium Chain Triglyceride Fat Emulsions in Young Children Before and After Open Heart Surgery
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- To determine whether incidence of sepsis and degree of inflammatory response is altered
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- — to 3 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
To determine whether incidence of sepsis and degree of inflammatory response is altered
Secondary Outcomes
- 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
Investigators
Study Sites (1)
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