Enteral FeedingNCT02806427
Tolerance of a Calorically Dense Enteral Nutrition Formula
An observational study of Enteral Feeding, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
This prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding
- What is being tested?
- Enteral Formula
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2016to 11 Mar 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with established enteral access receiving standard tube feeding formula in the ICU
Who may be able to join
- Adult aged > 18 years
- Admitted to Medical ICU with expected admission of ≥ 3 days
- Established enteral access
- Having obtained his/her or legal representative's informed consent.
Who cannot join
- Pregnant or lactating
- Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
- Lack of enteral access
- Parenteral nutrition
- Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, etc.)
- Subject who in the Investigator's assessment cannot be expected to comply with study protocol
- Currently participating in another conflicting clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
This prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.
- Conditions
- Enteral Feeding
- Being tested
- Enteral Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral FormulaOther
| Study group | Role | What they receive |
|---|---|---|
| enterally fed adults | Adults subjects with a condition for which a calorically dense enteral formula is appropriate, with established enteral access, anticipated to require enteral tube feeding for at least 3 days. Receives: Other: Enteral Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily percentage of caloric nutritional goal met
Measured: First 3 days in the ICU
Secondary outcomes (2)
Daily percentage of protein goal met
Measured: First 5 days in the ICU
Adverse events and serious adverse events
Measured: First 5 days in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start30 Jun 2016
- Primary completion11 Mar 2017
- Study completion11 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral FeedingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Allen, MD, Principal investigator, Oklahoma University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806427
- Sponsor's protocol ID
- 15.08.US.HCN
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2016
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of a Calorically Dense Enteral Nutrition Formula
- ClinicalTrials.gov ID
- NCT02806427
- Acronym / sponsor ID
- 15.08.US.HCN
- Conditions
- Enteral Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 11 Mar 2017 (actual)
- Study completion
- 11 Mar 2017 (actual)
- First posted
- 20 Jun 2016 (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 prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enterally fed adults | – | Other: Enteral FormulaAdults subjects with a condition for which a calorically dense enteral formula is appropriate, with established enteral access, anticipated to require enteral tube feeding for at least 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with established enteral access receiving standard tube feeding formula in the ICU
Key inclusion criteria (4 listed)
- Adult aged > 18 years
- Admitted to Medical ICU with expected admission of ≥ 3 days
- Established enteral access
- Having obtained his/her or legal representative's informed consent.
Key exclusion criteria (7 listed)
- Pregnant or lactating
- Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
- Lack of enteral access
- Parenteral nutrition
- Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, etc.)
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 |
|---|---|---|
| Enteral Formula | Other | enterally fed adults |
Primary outcome
Daily percentage of caloric nutritional goal met
Time frame: First 3 days in the ICU
2 secondary outcomes
Daily percentage of protein goal met
Time frame: First 5 days in the ICU
Adverse events and serious adverse events
Time frame: First 5 days in the ICU
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 2 Jul 2017.
- Individual participant dataSharing planned: No
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Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
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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.
Karen Allen, MD principal investigator
Oklahoma University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteral 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 7 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 2 Jul 2017. 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 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?
Daily percentage of caloric nutritional goal met (time frame: First 3 days in the ICU). 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 2 Jul 2017.