Feeding Trial in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01469117
First received: November 8, 2011
Last updated: August 6, 2014
Last verified: August 2014
  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:


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 ]

Enrollment: 16
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Oklahoma
The Children's Center
Bethany, Oklahoma, United States, 73008
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: August 6, 2014
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
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on October 29, 2014