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

• Sponsor: University of Alberta (Other)
• Overall Status: Completed
• CT.gov ID: NCT00336908
• Collaborator: Stollery Children's Hospital Foundation (Other)
• Enrollment: 32
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Cardiac Surgical Procedures	Drug: a combination of MCT, LCT , and Fish Oil	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Inflammatory Responses of Intravenous Fish Oil, Soybean Oil and Medium Chain Triglyceride Fat Emulsions in Young Children Before and After Open Heart Surgery
• Study Start Date: Nov 1, 2005
• Actual Study Completion Date: Nov 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 3 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stollery Children's Hospital	Edmonton	Alberta	Canada	T6G 2B7

Sponsors and Collaborators

• University of Alberta
• Stollery Children's Hospital Foundation

Investigators

• Principal Investigator: John E Van Aerde, MD, PhD, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00336908
• Other Study ID Numbers: 2030001 71860000074; UofA-JVA-2005-1
• First Posted: Jun 14, 2006
• Last Update Posted: Nov 27, 2007
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: Intensive Care,Neonatal; Parenteral nutrition; Fat emulsions,Intravenous
• Additional relevant MeSH terms: Inflammation

Study Results

No Results Posted as of Nov 27, 2007