Feeding Trial in Pediatric Patients
Completed
- Conditions
- Developmental Disabilities
- Registration Number
- NCT01469117
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- 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.
Exclusion Criteria
- Unable to access gastrointestinal tract for feeding via tube
- Other condition which contraindicates tube feeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to feeding goal achievement up to 14 days
- Secondary Outcome Measures
Name Time Method Gastrointestinal measures assessment up to 21 days Serum biochemical markers assessment baseline and completion of study Assessment of frequency and nature of adverse events daily up to 21 days Percentage of nutrition goal met daily up to 21 days
Trial Locations
- Locations (1)
The Children's Center
🇺🇸Bethany, Oklahoma, United States
The Children's Center🇺🇸Bethany, Oklahoma, United States