Developmental DisabilitiesNCT02912065
Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay
An observational study of Developmental Disabilities and Feeding Disorder, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
A retrospective chart review to assess feeding tolerance in children who had been switched from an intact protein formula to a Peptide based formula due to feeding intolerance in a pediatric facility for the developmentally delayed. Read more about this study
- Who is it for?
- Ages 13 months to 17 years
- Conditions the study is for
- Developmental Disabilities, Feeding Disorder
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Mar 2015
- 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 13 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The population studied retrospectively will be pediatric patients with developmental delays dependent on enteral nutrition for 90% or more of their nutritional needs and meeting the inclusion/ exclusion criteria.
Who may be able to join
- 13 months to < 18 years of age on admission to facility
- Required enteral nutrition to meet 90% or more of their energy needs prior to switch to a Peptide based formula
- Received enteral nutrition with an intact protein formula for a minimum of two weeks prior to a switch to a Peptide based formula
- Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a Peptide based formula
- Have documentation of an assessment of feeding tolerance following the switch to a Peptide based formula
- Formulas received must be indicated for use in children or adults (not infant formulas).
Who cannot join
- Recent abdominal surgery, change in tube position/placement (within past 30 days)
- Cow's milk protein allergy
- Any current infections including upper respiratory, viral, gastroenteritis, wound infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Center for Gastroenterology
Hollywood, Florida, 33021
About this study
Official title: Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay: A Retrospective Assessment
A retrospective chart review to assess feeding tolerance in children who had been switched from an intact protein formula to a Peptide based formula due to feeding intolerance in a pediatric facility for the developmentally delayed.
Read the detailed description
Medical records of pediatric patients with enteral feeding intolerance on standard polymeric formulas that were switched to a peptide based formula will be retrospectively analyzed. Data will be collected on caloric intake, ability to meet enteral nutrition goals, incidence of intolerance, and the use of medications to control gastrointestinal symptoms.
- Conditions
- Developmental Disabilities, Feeding Disorder
- Medical subject headings
- Developmental Disabilities, Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding tolerance after switching to Peptide based formula
Categorized as no change, tolerance improved, tolerance worsened.
Measured: up to 30 days post formula switch
Secondary outcomes (2)
Intake of target feeding volume
Documentation of feeding volume after switch as "less than," "about the same as," or "more than" feeding volume achieved before switch.
Measured: up to 30 days post formula switch
Feeding intolerance parameter(s) identified before switch to Peptide based formula and feeding tolerance parameter(s) improved by switch.
Intolerance Parameter's: Gagging/retching, vomiting, high residuals, abdominal distention/ gas, stool consistency issues (too hard, too loose).
Measured: up to 30 days post formula switch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMar 2015
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.
- 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
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Minor, PA-C, Principal investigator, Childrens Center for Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912065
- Sponsor's protocol ID
- 14.08.US.HCN
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: All data will be presented in manuscript
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay: A Retrospective Assessment
- ClinicalTrials.gov ID
- NCT02912065
- Acronym / sponsor ID
- 14.08.US.HCN
- Conditions
- Developmental Disabilities, Feeding Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Sep 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.
A retrospective chart review to assess feeding tolerance in children who had been switched from an intact protein formula to a Peptide based formula due to feeding intolerance in a pediatric facility for the developmentally delayed.
Detailed description
Medical records of pediatric patients with enteral feeding intolerance on standard polymeric formulas that were switched to a peptide based formula will be retrospectively analyzed. Data will be collected on caloric intake, ability to meet enteral nutrition goals, incidence of intolerance, and the use of medications to control gastrointestinal symptoms.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The population studied retrospectively will be pediatric patients with developmental delays dependent on enteral nutrition for 90% or more of their nutritional needs and meeting the inclusion/ exclusion criteria.
Key inclusion criteria (6 listed)
- 13 months to < 18 years of age on admission to facility
- Required enteral nutrition to meet 90% or more of their energy needs prior to switch to a Peptide based formula
- Received enteral nutrition with an intact protein formula for a minimum of two weeks prior to a switch to a Peptide based formula
- Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a Peptide based formula
- Have documentation of an assessment of feeding tolerance following the switch to a Peptide based formula
Key exclusion criteria (3 listed)
- Recent abdominal surgery, change in tube position/placement (within past 30 days)
- Cow's milk protein allergy
- Any current infections including upper respiratory, viral, gastroenteritis, wound infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feeding tolerance after switching to Peptide based formula
Time frame: up to 30 days post formula switch
Categorized as no change, tolerance improved, tolerance worsened.
2 secondary outcomes
Intake of target feeding volume
Time frame: up to 30 days post formula switch
Feeding intolerance parameter(s) identified before switch to Peptide based formula and feeding tolerance parameter(s) improved by switch.
Time frame: up to 30 days post formula 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 5 Oct 2016.
- Individual participant dataSharing planned: No. All data will be presented in manuscript
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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, PA-C principal investigator
Childrens Center for Gastroenterology
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 and Feeding Disorder, 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 6 inclusion and 3 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 5 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?
Feeding tolerance after switching to Peptide based formula (time frame: up to 30 days post 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 5 Oct 2016.