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Feeding Trial in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT01469117
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : August 7, 2014
Information provided by (Responsible Party):

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
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 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 : November 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort 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

Primary Outcome Measures :
  1. Time to feeding goal achievement [ Time Frame: up to 14 days ]

Secondary Outcome Measures :
  1. Gastrointestinal measures assessment [ Time Frame: up to 21 days ]
  2. Percentage of nutrition goal met [ Time Frame: daily up to 21 days ]
  3. Serum biochemical markers assessment [ Time Frame: baseline and completion of study ]
  4. Assessment of frequency and nature of adverse events [ Time Frame: daily up to 21 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with developmental disabilities

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469117

United States, Oklahoma
The Children's Center
Bethany, Oklahoma, United States, 73008
Sponsors and Collaborators
Principal Investigator: Darin Brannan, MD The Children's Center

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01469117     History of Changes
Other Study ID Numbers: 11.03.US.HCN
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

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

Additional relevant MeSH terms:
Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders