Clinical Trial: Feeding Trial in Pediatric Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities
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 Summary: 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.
Sponsor: Nestlé
Current Primary Outcome: Time to feeding goal achievement [ Time Frame: up to 14 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Nestlé
Dates:
Date Received: November 8, 2011
Date Started: November 2011
Date Completion:
Last Updated: August 6, 2014
Last Verified: August 2014
