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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammation Cardiac Surgical Procedures

Keywords

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Intensive Care,Neonatal Parenteral nutrition Fat emulsions,Intravenous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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a combination of MCT, LCT , and Fish Oil

Intervention Type DRUG

Eligibility Criteria

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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)

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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John E Van Aerde, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED

PMID: 22136963 (View on PubMed)

Other Identifiers

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UofA-JVA-2005-1

Identifier Type: -

Identifier Source: secondary_id

2030001 71860000074