NCT01469117
Completed
N/A
Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities
Société des Produits Nestlé (SPN)1 site in 1 country16 target enrollmentNovember 2011
ConditionsDevelopmental Disabilities
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Developmental Disabilities
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Time to feeding goal achievement
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time to feeding goal achievement
Time Frame: up to 14 days
Secondary Outcomes
- Percentage of nutrition goal met(daily up to 21 days)
- 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)
Study Sites (1)
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