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

Inflammatory Responses of Intravenous Fish Oil, Soybean Oil and Medium Chain Triglyceride Fat Emulsions in Young Children Before and After Open Heart Surgery

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00336908

Enrollment

Registered

2006-06-14

Start date

2005-11-30

Completion date

2007-11-30

Last updated

2007-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgical Procedures, Inflammation

Keywords

Intensive Care,Neonatal, Parenteral nutrition, Fat emulsions,Intravenous

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.

Interventions

DRUGa combination of MCT, LCT , and Fish Oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Months

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)

Design outcomes

Primary

Measure	Time frame
To determine whether incidence of sepsis and degree of inflammatory response is altered	—

Secondary

Measure	Time frame
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	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026