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OpenTrials
Completed

NCT Number: NCT01469117

Feeding Trial in Pediatric Patients

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.

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Key information

Conditions

Developmental Disabilities Mental Disorders Neurodevelopmental Disorders

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Center

Bethany, Oklahoma, 73008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral Formula

Other

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

Primary outcomes

  1. Time to feeding goal achievement

    Time frame: up to 14 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 10, 2011
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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