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

NCT00336908 | Completed Phase 2

• 2 other identifiers: 2030001 71860000074UofA-JVA-2005-1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Cardiac Surgical Procedures

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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

Interventions

a combination of MCT, LCT , and Fish Oil DRUG

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• weeks gestation
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead
• Stollery Children's Hospital Foundation: collaborator

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

• Larsen BM, Goonewardene LA, Joffe AR, Van Aerde JE, Field CJ, Olstad DL, Clandinin MT. Pre-treatment with an intravenous lipid emulsion containing fish oil (eicosapentaenoic and docosahexaenoic acid) decreases inflammatory markers after open-heart surgery in infants: a randomized, controlled trial. Clin Nutr. 2012 Jun;31(3):322-9. doi: 10.1016/j.clnu.2011.11.006. Epub 2011 Dec 3.

  PMID: 22136963 DERIVED

MeSH Terms

Conditions

Inflammation; Hyperphagia

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• John E Van Aerde, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 14, 2006
• Study Start: November 1, 2005
• Study Completion: November 1, 2007
• Last Updated: November 27, 2007

Record last verified: 2007-11

Locations

CA (1)