Enteral Feeding IntoleranceNCT04247269
Review of Enteral Formulas in Children
An observational study of Enteral Feeding Intolerance and Tube Feeding, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
Retrospective review of nutrition enteral formula data documented in medical records. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Enteral Feeding Intolerance, Tube Feeding, Nutrition Disorder, Child
- What is being tested?
- Enteral Tube Feeding
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to 2 Jun 2022
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Population studied retrospectively will be children with a history of enteral tube feeding in a home setting and meeting inclusion/exclusion criteria
Who may be able to join
- Minimum 12 months enteral feeding
- History of enteral feeding with intact or semi-elemental formula
Who cannot join
- Medical records lacking enteral nutrition feeding use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Review of Enteral Formulas in Medically Complex Children
Retrospective review of nutrition enteral formula data documented in medical records.
Read the detailed description
This is a retrospective review to assess nutrition (calorie and protein) intake of enteral formula data documented in medical records of patients that consumed enteral tube feeding formulas at home.
- Being tested
- Enteral Tube Feeding
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral Tube FeedingOther
Enteral tube feeding
| Study group | Role | What they receive |
|---|---|---|
| Enteral formula standard | Children fed an intact protein formula Receives: Other: Enteral Tube Feeding | |
| Enteral formula semi-elemental | Children fed a semi-elemental protein formula Receives: Other: Enteral Tube Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition Intake
Assessment of enteral formula calorie and protein intake compared to nutrition prescription
Measured: 12 months
Secondary outcomes (5)
Body weight
Weight in kilograms
Measured: 12 months
Length/height
Length/height (based on age) in centimeters
Measured: 12 months
Formula volume consumption
Assessment of enteral formula volume compared to nutrition prescription
Measured: 12 months
Stool frequency
Number of stools reported in medical record
Measured: 12 months
Ventilator status
Assessment of ventilator change; extubated or continued
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start21 Aug 2020
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Why it stopped: Site closure due to Covid Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Feeding IntoleranceStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krysmaru AraujoTorres, MD, Study director, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247269
- Sponsor's protocol ID
- 19.02.US.HCN
- Status last verified
- Apr 2021
- First submitted
- 23 Jan 2020
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Enteral Formulas in Medically Complex Children
- ClinicalTrials.gov ID
- NCT04247269
- Acronym / sponsor ID
- 19.02.US.HCN
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Site closure due to Covid Pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 30 Jan 2020 (actual)
- 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.
Retrospective review of nutrition enteral formula data documented in medical records.
Detailed description
This is a retrospective review to assess nutrition (calorie and protein) intake of enteral formula data documented in medical records of patients that consumed enteral tube feeding formulas at home.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral formula standard | – | Other: Enteral Tube FeedingChildren fed an intact protein formula |
| Enteral formula semi-elemental | – | Other: Enteral Tube FeedingChildren fed a semi-elemental protein formula |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Population studied retrospectively will be children with a history of enteral tube feeding in a home setting and meeting inclusion/exclusion criteria
Key inclusion criteria (2 listed)
- Minimum 12 months enteral feeding
- History of enteral feeding with intact or semi-elemental formula
Key exclusion criteria (1 listed)
- Medical records lacking enteral nutrition feeding use
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 Tube FeedingEnteral tube feeding | Other | Enteral formula semi-elemental, Enteral formula standard |
Primary outcome
Nutrition Intake
Time frame: 12 months
Assessment of enteral formula calorie and protein intake compared to nutrition prescription
5 secondary outcomes
Body weight
Time frame: 12 months
Length/height
Time frame: 12 months
Formula volume consumption
Time frame: 12 months
Stool frequency
Time frame: 12 months
Ventilator status
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Enteral Feeding Intolerance
Not yet recruitingObservational study
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
Recruiting
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Enteral Feeding Intolerance
Recruiting
Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
Enteral Feeding Intolerance, Critical Illness
Not yet recruitingObservational study
Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
Refractory Enteral Feeding Intolerance, Gut Microbiota
Not yet recruiting
Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance
Enteral Feeding Intolerance, ICU
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.
Krysmaru AraujoTorres, MD study director
Société des Produits Nestlé (SPN)
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 Intolerance 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 Jun 2022. 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 withdrawn before enrolling participants, so there are no results.
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?
Nutrition Intake (time frame: 12 months). 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 9 Jun 2022.