Feeding Trial in Pediatric Patients

August 6, 2014 updated by: Nestlé

Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • The Children's Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with developmental disabilities

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to feeding goal achievement
Time Frame: up to 14 days
up to 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Gastrointestinal measures assessment
Time Frame: up to 21 days
up to 21 days
Percentage of nutrition goal met
Time Frame: daily up to 21 days
daily up to 21 days
Serum biochemical markers assessment
Time Frame: baseline and completion of study
baseline and completion of study
Assessment of frequency and nature of adverse events
Time Frame: daily up to 21 days
daily up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

November 8, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 10, 2011

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

August 6, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.03.US.HCN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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