Critically Ill ChildrenNCT03017664
Improvement Project To Optimizing Nutrition With Higher Protein and Calorie Pediatric Tube Feeding
An observational study of Critically Ill Children, run by Société des Produits Nestlé (SPN) at 2 sites in United States.
Trial summary
This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients. Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Critically Ill Children
- What is being tested?
- Peptide-based enteral formula and Retrospective review of enteral tube feeding formula
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2018to 31 Dec 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 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1-13 years with enteral feeding access
Who may be able to join
- Children aged 1-18 years old with enteral feeding access and anticipated to be fed for 5 days
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Chicago, Comer Children's Hospital
Chicago, Illinois, 60637
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
About this study
Official title: An Improvement Project Towards Optimizing Nutrition Intervention With a Higher Protein and Calorie Pediatric Tube Feeding Formula
This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients.
Read the detailed description
This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients. The primary aim of this quality improvement project is to better meet protein needs of ICU critically ill children
- Conditions
- Critically Ill Children
- Being tested
- Peptide-based enteral formula, Retrospective review of enteral tube feeding formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide-based enteral formulaOther
Peptide-based, higher protein and higher calorie enteral formula
Retrospective review of enteral tube feeding formulaOther
Enteral formula tube feeding will be retrospectively reviewed
| Study group | Role | What they receive |
|---|---|---|
| RFG | Retrospective review of enteral feeding in pediatric ICU patients for up to 5 days Receives: Other: Retrospective review of enteral tube feeding formula | |
| PFG | Pediatric ICU population to be fed a peptide-based enteral formula with higher protein and higher calories for up to 5 days Receives: Other: Peptide-based enteral formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteral formula volume
Daily total formula volume (mL) delivered
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start15 Jan 2018
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill ChildrenStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krysmaru B AraujoTorres, MD, Study director, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017664
- Sponsor's protocol ID
- 16.04.US.HCN
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2017
- Last updated
- 27 Jan 2020
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Improvement Project Towards Optimizing Nutrition Intervention With a Higher Protein and Calorie Pediatric Tube Feeding Formula
- ClinicalTrials.gov ID
- NCT03017664
- Acronym / sponsor ID
- 16.04.US.HCN
- Conditions
- Critically Ill Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jan 2017 (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 quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients.
Detailed description
This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients. The primary aim of this quality improvement project is to better meet protein needs of ICU critically ill children
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFG | – | Other: Retrospective review of enteral tube feeding formulaRetrospective review of enteral feeding in pediatric ICU patients for up to 5 days |
| PFG | – | Other: Peptide-based enteral formulaPediatric ICU population to be fed a peptide-based enteral formula with higher protein and higher calories for up to 5 days |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1-13 years with enteral feeding access
Key inclusion criteria (1 listed)
- Children aged 1-18 years old with enteral feeding access and anticipated to be fed for 5 days
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Peptide-based enteral formulaPeptide-based, higher protein and higher calorie enteral formula | Other | PFG |
| Retrospective review of enteral tube feeding formulaEnteral formula tube feeding will be retrospectively reviewed | Other | RFG |
Primary outcome
Enteral formula volume
Time frame: 5 days
Daily total formula volume (mL) delivered
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 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Krysmaru B AraujoTorres, MD study director
Société des Produits Nestlé (SPN)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill Children, run by Société des Produits Nestlé (SPN) at 2 sites 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Enteral formula volume (time frame: 5 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 27 Jan 2020.