Enteral NutritionNCT02779335
Enteral Formula Tolerance in Pediatric Patients
A study testing Enteral Formula in people with Enteral Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population. Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- Enteral Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Oct 2016
- 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 1 year to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 - 13 years of age
- Currently tolerating enteral feeding
- Has enteral access
- Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 9 days
- Having obtained his/her and/or his/her legal representative's informed consent
Who cannot join
- Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
- Lack of enteral access
- Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
- Judged to be at risk for poor compliance to the study protocol
- Lack of informed consent
- Currently participating in another conflicting clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Center for GI and Nutrition
Hollywood, Florida, 33021
About this study
The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.
Read the detailed description
In this prospective study, a population of stable, tube-fed children will consume a standard polymetric tube feeding formula to assess ability to achieve enteral feeding goals and tolerance outcomes.
- Conditions
- Enteral Nutrition
- Being tested
- Enteral Formula
- Keywords
- tube-fed, Formula Tolerance, Pediatric Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral FormulaOther
pediatric subjects will be fed a standard pediatric enteral formula tube feeding
| Study group | Role | What they receive |
|---|---|---|
| Enteral formula tube feeding | Other | Enteral fed children, ages 1-13, with establish enteral feeding access 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: 9 days
Secondary outcomes (7)
Daily percentage of protein goal met
Measured: 9 days
Daily assessment of gastrointestinal tolerance - stool consistency
Daily assessment of stool consistency (liquid, formed, soft)
Measured: 9 days
Daily assessment of gastrointestinal tolerance- Stool frequency
Daily assessment of number of stool
Measured: 9 days
Daily assessment of gastrointestinal tolerance- Vomit
Daily assessment of frequency of vomit
Measured: 9 days
Daily assessment of gastrointestinal tolerance - Flatulence
Daily assessment of presence of flatulence
Measured: 9 days
Daily assessment of gastrointestinal tolerance - Abdominal pain
Daily assessment of abdominal pain
Measured: 9 days
Frequency and nature of adverse events
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Minor, MMS, PA-C, Principal investigator, Children's Center for GI and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779335
- Sponsor's protocol ID
- 15.09.US.HCN
- Status last verified
- Mar 2016
- First submitted
- 18 Mar 2016
- Last updated
- 21 Oct 2016
- 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 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Formula Tolerance in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02779335
- Acronym / sponsor ID
- 15.09.US.HCN
- Conditions
- Enteral Nutrition
- Keywords
- tube-fed, Formula Tolerance, Pediatric Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 May 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.
The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.
Detailed description
In this prospective study, a population of stable, tube-fed children will consume a standard polymetric tube feeding formula to assess ability to achieve enteral feeding goals and tolerance outcomes.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteral formula tube feeding | Other | Other: Enteral FormulaEnteral fed children, ages 1-13, with establish enteral feeding access |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1 - 13 years of age
- Currently tolerating enteral feeding
- Has enteral access
- Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 9 days
- Having obtained his/her and/or his/her legal representative's informed consent
Key exclusion criteria (6 listed)
- Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
- Lack of enteral access
- Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
- Judged to be at risk for poor compliance to the study protocol
- Lack of informed consent
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 Formulapediatric subjects will be fed a standard pediatric enteral formula tube feeding | Other | Enteral formula tube feeding |
Primary outcome
Daily percentage of caloric nutritional goal met
Time frame: 9 days
7 secondary outcomes
Daily percentage of protein goal met
Time frame: 9 days
Daily assessment of gastrointestinal tolerance - stool consistency
Time frame: 9 days
Daily assessment of gastrointestinal tolerance- Stool frequency
Time frame: 9 days
Daily assessment of gastrointestinal tolerance- Vomit
Time frame: 9 days
Daily assessment of gastrointestinal tolerance - Flatulence
Time frame: 9 days
Daily assessment of gastrointestinal tolerance - Abdominal pain
Time frame: 9 days
Frequency and nature of adverse events
Time frame: 9 days
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 21 Oct 2016.
- Individual participant dataSharing planned: No
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FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
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Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
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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.
Gerard Minor, MMS, PA-C principal investigator
Children's Center for GI and Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral Formula in people with Enteral Nutrition, 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 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 21 Oct 2016. 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: 9 days). 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 21 Oct 2016.