Feeding Trial in Pediatric Patients

NCT ID: NCT01469117

Last Updated: 2014-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Developmental Disabilities

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric developmental disabilities

Children aged 1-13 years old with development disabilities, requiring enteral tube feeding for at least 14 days

enteral formula

Intervention Type OTHER

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

Interventions

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enteral formula

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darin Brannan, MD

Role: PRINCIPAL_INVESTIGATOR

The Children's Center

Locations

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The Children's Center

Bethany, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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11.03.US.HCN

Identifier Type: -

Identifier Source: org_study_id

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