InflammationPhase 2/3NCT00336908
Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery
A Phase 2/3 study testing a combination of MCT, LCT , and Fish Oil in people with Inflammation and Cardiac Surgical Procedures, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Inflammation, Cardiac Surgical Procedures
- What is being tested?
- a combination of MCT, LCT , and Fish Oil
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2005to Nov 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- a combination of MCT, LCT , and Fish Oil
- Keywords
- Intensive Care,Neonatal, Parenteral nutrition, Fat emulsions,Intravenous
- Medical subject headings
- Inflammation, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a combination of MCT, LCT , and Fish OilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
- Study startNov 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Stollery Children's Hospital Foundation
- Investigators
- John E Van Aerde, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336908
- Sponsor's protocol ID
- 2030001 71860000074
- Other IDs
- UofA-JVA-2005-1
- Status last verified
- Nov 2007
- First submitted
- 13 Jun 2006
- Last updated
- 27 Nov 2007
- Results posted
- No
Publications
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.
PubMed 22136963
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00336908
- Acronym / sponsor ID
- 2030001 71860000074
- Conditions
- Inflammation, Cardiac Surgical Procedures
- Keywords
- Intensive Care,Neonatal, Parenteral nutrition, Fat emulsions,Intravenous
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Stollery Children's Hospital Foundation
- Study start
- Nov 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 14 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a combination of MCT, LCT , and Fish Oil | Drug | – |
Primary outcome
To determine whether incidence of sepsis and degree of inflammatory response is altered
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2007.
- Derived from this study: PubMed 22136963Larsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E Van Aerde, MD, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing a combination of MCT, LCT , and Fish Oil in people with Inflammation and Cardiac Surgical Procedures, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether incidence of sepsis and degree of inflammatory response is altered. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00336908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2007; AzTrials last refreshed its copy on 7 Nov 2026.