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

University of Alberta32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Inflammation Cardiac Surgical Procedures

Interventions

a combination of MCT, LCT , and Fish OilDRUG

Eligibility

Sex: ALLMax age: 3 Months

Medical Language ↔ Plain English

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)

Locations (1)

Stollery Children's Hospital

Edmonton, Alberta, Canada

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.