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Feeding Trial in Pediatric Patients

This study is currently recruiting participants.
Verified January 2012 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01469117
First received: November 8, 2011
Last updated: January 6, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Developmental Disabilities
 Other: enteral formula

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Time to feeding goal achievement [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gastrointestinal measures assessment [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Percentage of nutrition goal met [ Time Frame: daily up to 21 days ] [ Designated as safety issue: No ]
  • Serum biochemical markers assessment [ Time Frame: baseline and completion of study ] [ Designated as safety issue: No ]
  • Assessment of frequency and nature of adverse events [ Time Frame: daily up to 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   1 Year to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients with developmental disabilities

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469117

Contacts
Contact: Amy Kluge, APN (405) 440-6780 akluge@tccoke.org

Locations
United States, Oklahoma
The Children's Center Recruiting
Bethany, Oklahoma, United States, 73008
Contact: Amy Kluge, APN     405-440-6780     akluge@tccoke.org    
Principal Investigator: Darin Brannan, MD            
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Darin Brannan, MD The Children's Center
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01469117     History of Changes
Other Study ID Numbers: 11.03.US.HCN
Study First Received: November 8, 2011
Last Updated: January 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
Developmental disabilities
Enteral Nutrition
Tube feeding
Nutrition support

Additional relevant MeSH terms:
Developmental Disabilities
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013