Developmental DisabilitiesNCT01469117
Feeding Trial in Pediatric Patients
An observational study of Developmental Disabilities, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
This is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities. Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Developmental Disabilities
- What is being tested?
- enteral formula
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2013
- 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: Pediatric patients with developmental disabilities
Who may be able to join
- Child aged 1-13 years old with development disabilities
- Currently tolerating enteral feeding
- Requiring nutritional management to meet 50-90th% weight for age on the Kennedy Kreiger Growth Charts
- Requires enteral tube feeding for at least 14 days.
Who cannot join
- Unable to access gastrointestinal tract for feeding via tube
- Other condition which contraindicates tube feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities
This is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities.
Read the detailed description
This prospective observational study seeks to assess ability to achieve enteral feeding goals with a new tube feeding product in pediatric patients with developmental disabilities.
- Conditions
- Developmental Disabilities
- Being tested
- enteral formula
- Keywords
- Developmental disabilities, Enteral Nutrition, Tube feeding, Nutrition support
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral formulaOther
Complete feeding of study enteral formula, route and regimen prescribed by the physician
| Study group | Role | What they receive |
|---|---|---|
| Pediatric developmental disabilities | Children aged 1-13 years old with development disabilities, requiring enteral tube feeding for at least 14 days Receives: Other: enteral formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to feeding goal achievement
Measured: up to 14 days
Secondary outcomes (4)
Gastrointestinal measures assessment
Measured: up to 21 days
Percentage of nutrition goal met
Measured: daily up to 21 days
Serum biochemical markers assessment
Measured: baseline and completion of study
Assessment of frequency and nature of adverse events
Measured: daily up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilitiesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darin Brannan, MD, Principal investigator, The Children's Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469117
- Sponsor's protocol ID
- 11.03.US.HCN
- Status last verified
- Aug 2014
- First submitted
- 8 Nov 2011
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities
- ClinicalTrials.gov ID
- NCT01469117
- Acronym / sponsor ID
- 11.03.US.HCN
- Conditions
- Developmental Disabilities
- Keywords
- Developmental disabilities, Enteral Nutrition, Tube feeding, Nutrition support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Nov 2011 (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 is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities.
Detailed description
This prospective observational study seeks to assess ability to achieve enteral feeding goals with a new tube feeding product in pediatric patients with developmental disabilities.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric developmental disabilities | – | Other: enteral formulaChildren aged 1-13 years old with development disabilities, requiring enteral tube feeding for at least 14 days |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with developmental disabilities
Key inclusion criteria (4 listed)
- Child aged 1-13 years old with development disabilities
- Currently tolerating enteral feeding
- Requiring nutritional management to meet 50-90th% weight for age on the Kennedy Kreiger Growth Charts
- Requires enteral tube feeding for at least 14 days.
Key exclusion criteria (2 listed)
- Unable to access gastrointestinal tract for feeding via tube
- Other condition which contraindicates tube feeding
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 formulaComplete feeding of study enteral formula, route and regimen prescribed by the physician | Other | Pediatric developmental disabilities |
Primary outcome
Time to feeding goal achievement
Time frame: up to 14 days
4 secondary outcomes
Gastrointestinal measures assessment
Time frame: up to 21 days
Percentage of nutrition goal met
Time frame: daily up to 21 days
Serum biochemical markers assessment
Time frame: baseline and completion of study
Assessment of frequency and nature of adverse events
Time frame: daily up to 21 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 7 Aug 2014.
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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.
Darin Brannan, MD principal investigator
The Children's 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 Developmental Disabilities, 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 2 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 7 Aug 2014. 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?
Time to feeding goal achievement (time frame: up to 14 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 7 Aug 2014.