Feeding Trial in Pediatric Patients

Developmental Disabilities Clinical Trial

Official title:

Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469117
• Other study ID #: 11.03.US.HCN
• Status: Completed
• Phase: N/A
• First received: November 8, 2011
• Last updated: August 6, 2014
• Start date: November 2011
• Est. completion date: January 2013

Study information

• Verified date: August 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 13 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Developmental Disabilities

Intervention

Other:
• enteral formula
Complete feeding of study enteral formula, route and regimen prescribed by the physician

Locations

Country	Name	City	State
United States	The Children's Center	Bethany	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to feeding goal achievement		up to 14 days	No
Secondary	Gastrointestinal measures assessment		up to 21 days	No
Secondary	Percentage of nutrition goal met		daily up to 21 days	No
Secondary	Serum biochemical markers assessment		baseline and completion of study	No
Secondary	Assessment of frequency and nature of adverse events		daily up to 21 days	No