TraumaNCT00421941
Enteral Feeding Study of Formula Containing Fish Oil in Critical Care Setting
A study testing Tube feeding in people with Trauma and Tube Feeding, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical applicability of an enteral tube feeding formula containing fish oil and prebiotics in a critical care population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Trauma, Tube Feeding
- What is being tested?
- Tube feeding
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2008
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 70 years old
- New ICU admit
- Enteral tube feeding anticipated for at least 7 days
- Informed consent
Who cannot join
- Enteral tube feeding immediately prior to admit
- Parenteral feeding
- Medical condition that preclude receiving tube feeding or formula
- Determined by PI to be inappropriate
- Participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Use of a High-protein Enteral Formula Containing Prebiotics and Fish Oil in Critical Care
The purpose of this study is to evaluate the clinical applicability of an enteral tube feeding formula containing fish oil and prebiotics in a critical care population.
Read the detailed description
In terms of nutrition support in the acute care setting, it is generally accepted that
- earlier is better
- enteral is superior to parenteral
- the quality of nutrients appears more important than quantity
- select populations will show additional benefit from specific nutrient supplementation.
The current study is designed to evaluate the tolerance of an enteral formula in trauma and surgery patients, as demonstrated by achieving and maintaining enteral feeding goal, gastrointestinal tolerance and inflammatory markers.
- Conditions
- Trauma, Tube Feeding
- Being tested
- Tube feeding
- Keywords
- enteral feeding, critical care, fish oil, surgical
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tube feedingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical applicability as measured by the length of time between start of feeding to the first achievement of 800ml/day
Secondary outcomes (4)
Gastrointestinal tolerance
Time to advance to full feed
Inflammatory markers
Infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Unable to meet enrollment goal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Martindale, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421941
- Sponsor's protocol ID
- 06.06.US.HCN
- Status last verified
- Oct 2013
- First submitted
- 12 Jan 2007
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a High-protein Enteral Formula Containing Prebiotics and Fish Oil in Critical Care
- ClinicalTrials.gov ID
- NCT00421941
- Acronym / sponsor ID
- 06.06.US.HCN
- Conditions
- Trauma, Tube Feeding
- Keywords
- enteral feeding, critical care, fish oil, surgical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet enrollment goal
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Jan 2007 (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.
The purpose of this study is to evaluate the clinical applicability of an enteral tube feeding formula containing fish oil and prebiotics in a critical care population.
Detailed description
In terms of nutrition support in the acute care setting, it is generally accepted that
- earlier is better
- enteral is superior to parenteral
- the quality of nutrients appears more important than quantity
- select populations will show additional benefit from specific nutrient supplementation.
The current study is designed to evaluate the tolerance of an enteral formula in trauma and surgery patients, as demonstrated by achieving and maintaining enteral feeding goal, gastrointestinal tolerance and inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 70 years old
- New ICU admit
- Enteral tube feeding anticipated for at least 7 days
- Informed consent
Key exclusion criteria (5 listed)
- Enteral tube feeding immediately prior to admit
- Parenteral feeding
- Medical condition that preclude receiving tube feeding or formula
- Determined by PI to be inappropriate
- Participating in another clinical trial
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 |
|---|---|---|
| Tube feeding | Procedure or surgery | – |
Primary outcome
Clinical applicability as measured by the length of time between start of feeding to the first achievement of 800ml/day
4 secondary outcomes
Gastrointestinal tolerance
Time to advance to full feed
Inflammatory markers
Infection
Results and safety
The study was stopped early (reason given: Unable to meet enrollment goal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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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.
Robert Martindale, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tube feeding in people with Trauma and Tube Feeding, run by Société des Produits Nestlé (SPN) at 1 site in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Nov 2013. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Unable to meet enrollment goal). Results are not available in the source record.
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?
Clinical applicability as measured by the length of time between start of feeding to the first achievement of 800ml/day. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2013.