Children Requiring Amino Acid-based Formula Tube FeedingNCT03497091
Retrospective Review of Amino Acid Formula Use at a Children's Center
An observational study of Children Requiring Amino Acid-based Formula Tube Feeding and Enteral Feeding Intolerance, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
This is a retrospective review of 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
- Children Requiring Amino Acid-based Formula Tube Feeding, Enteral Feeding Intolerance
- What is being tested?
- Enteral Formula
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 31 Jan 2019
- 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: The population studied retrospectively will be children in a pediatric feeding center consuming an amino acid-based enteral fomula and meeting the inclusion/ exclusion criteria.
Who may be able to join
- Consuming or with a history of consuming an amino acid-based formula
Who cannot join
- Medical records lacking information on consumption of an amino acid-based formula
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Center for Rehabilitation Hospital
Oklahoma City, Oklahoma, 73008
About this study
This is a retrospective review of data documented in medical records.
Read the detailed description
This is a retrospective review of data documented in medical records of patients consuming an amino-acid based enteral formula at a pediatric care facility in the United States.
- 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
Enteral Feeding with an amino acid-based formula
| Study group | Role | What they receive |
|---|---|---|
| Enteral Tube fed children | Enteral Formula Receives: Other: Enteral Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented indication for formula use
Medical diagnosis
Measured: Up to 12 months before formula switch
Secondary outcomes (6)
Body weight
Body weight in kilograms
Measured: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Length/height
Length or height (based on age) in centimeters
Measured: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Formula volume consumption
Average of 7 days
Measured: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Stool frequency
Average of 7 days
Measured: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Stool consistency
Average of 7 days
Measured: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Vomiting
Average of 7 days
Measured: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start15 Jun 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Requiring Amino Acid-based Formula Tube 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23 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
- NCT03497091
- Sponsor's protocol ID
- 17.10.US.HCN
- Status last verified
- Nov 2019
- First submitted
- 5 Apr 2018
- Last updated
- 19 Nov 2019
- 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 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Amino Acid Formula Use at a Children's Center
- ClinicalTrials.gov ID
- NCT03497091
- Acronym / sponsor ID
- 17.10.US.HCN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 13 Apr 2018 (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.
This is a retrospective review of data documented in medical records.
Detailed description
This is a retrospective review of data documented in medical records of patients consuming an amino-acid based enteral formula at a pediatric care facility in the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteral Tube fed children | – | Other: Enteral FormulaEnteral Formula |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The population studied retrospectively will be children in a pediatric feeding center consuming an amino acid-based enteral fomula and meeting the inclusion/ exclusion criteria.
Key inclusion criteria (1 listed)
- Consuming or with a history of consuming an amino acid-based formula
Key exclusion criteria (1 listed)
- Medical records lacking information on consumption of an amino acid-based formula
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 FormulaEnteral Feeding with an amino acid-based formula | Other | Enteral Tube fed children |
Primary outcome
Documented indication for formula use
Time frame: Up to 12 months before formula switch
Medical diagnosis
6 secondary outcomes
Body weight
Time frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Length/height
Time frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Formula volume consumption
Time frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Stool frequency
Time frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Stool consistency
Time frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Vomiting
Time frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
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 19 Nov 2019.
- Individual participant dataSharing planned: No
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 Children Requiring Amino Acid-based Formula Tube Feeding and Enteral Feeding Intolerance, 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 1 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: finished, as of the sponsor's last update on 19 Nov 2019. 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?
Documented indication for formula use (time frame: Up to 12 months before formula switch). 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 19 Nov 2019.