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

NCT00336908 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2007-11-27

No results posted yet for this study

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

Interventions

DRUG

a combination of MCT, LCT , and Fish Oil

Sponsors & Collaborators

  • Stollery Children's Hospital Foundation

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • John E Van Aerde, MD, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Completion
2007-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00336908 on ClinicalTrials.gov