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

University of Alberta

Status and phase

Completed

Phase 3

Phase 2

Conditions

Inflammation

Cardiac Surgical Procedures

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00336908

2030001 71860000074

UofA-JVA-2005-1

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

Under 3 months old

Volunteers

No Healthy Volunteers

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)