Developmental Disabilities
Conditions
Keywords
Developmental disabilities, Enteral Nutrition, Tube feeding, Nutrition support
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.
Interventions
OTHERenteral formula
Complete feeding of study enteral formula, route and regimen prescribed by the physician
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to feeding goal achievement | up to 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal measures assessment | up to 21 days |
| Percentage of nutrition goal met | daily 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 |
Countries
United States
Outcome results
None listed