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Completed

NCT Number: NCT00336908

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

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.

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Key information

Conditions

Inflammation Cardiac Surgical Procedures Hyperphagia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

a combination of MCT, LCT , and Fish Oil

Drug

Primary outcomes

  1. To determine whether incidence of sepsis and degree of inflammatory response is altered

Secondary outcomes

  1. To characterize serum arachidonic acid and eicosapentaenoic acid levels, leukotriene B 4/leukotriene B 5 levels and incidence of nosocomial infection

  2. To characterize incidental findings as a result of attaining complete fatty acid and cytokine profiles

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Stollery Children's Hospital Foundation

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Jun 14, 2006
Registry last updated
Nov 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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