Feeding Trial in Pediatric Patients

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01469117
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Developmental Disabilities	Other: enteral formula

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 16 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Pediatric developmental disabilities Children aged 1-13 years old with development disabilities, requiring enteral tube feeding for at least 14 days	Other: enteral formula; Complete feeding of study enteral formula, route and regimen prescribed by the physician

Outcome Measures

Primary Outcome Measures

1. Time to feeding goal achievement [up to 14 days]

Secondary Outcome Measures

1. Gastrointestinal measures assessment [up to 21 days]

2. Percentage of nutrition goal met [daily up to 21 days]

3. Serum biochemical markers assessment [baseline and completion of study]

4. Assessment of frequency and nature of adverse events [daily up to 21 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 13 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Children's Center	Bethany	Oklahoma	United States	73008

Sponsors and Collaborators

• Nestlé

Investigators

• Principal Investigator: Darin Brannan, MD, The Children's Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT01469117
• Other Study ID Numbers: 11.03.US.HCN
• First Posted: Nov 10, 2011
• Last Update Posted: Aug 7, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by Nestlé: Developmental disabilities; Enteral Nutrition; Tube feeding; Nutrition support
• Additional relevant MeSH terms: Developmental Disabilities

Study Results

No Results Posted as of Aug 7, 2014