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
Verified date | November 2007 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | November 2007 |
Est. primary completion date | |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Stollery Children's Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Stollery Children's Hospital Foundation |
Canada,
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 |
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