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OpenTrials
Completed

NCT Number: NCT02779335

Enteral Formula Tolerance in Pediatric Patients

The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.

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Key information

Conditions

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Center for GI and Nutrition

Hollywood, Florida, 33021, United States

About this study

In this prospective study, a population of stable, tube-fed children will consume a standard polymetric tube feeding formula to assess ability to achieve enteral feeding goals and tolerance outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1 - 13 years of age
  • Currently tolerating enteral feeding
  • Has enteral access
  • Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 9 days
  • Having obtained his/her and/or his/her legal representative's informed consent

Exclusion criteria

  • Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
  • Lack of enteral access
  • Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
  • Judged to be at risk for poor compliance to the study protocol
  • Lack of informed consent
  • Currently participating in another conflicting clinical trial

Treatment and study plan

Enteral Formula

Other

pediatric subjects will be fed a standard pediatric enteral formula tube feeding

Primary outcomes

  1. Daily percentage of caloric nutritional goal met

    Time frame: 9 days

Secondary outcomes

  1. Daily percentage of protein goal met

    Time frame: 9 days

  2. Daily assessment of gastrointestinal tolerance - stool consistency

    Time frame: 9 days

    Daily assessment of stool consistency (liquid, formed, soft)

  3. Daily assessment of gastrointestinal tolerance- Stool frequency

    Time frame: 9 days

    Daily assessment of number of stool

  4. Daily assessment of gastrointestinal tolerance- Vomit

    Time frame: 9 days

    Daily assessment of frequency of vomit

  5. Daily assessment of gastrointestinal tolerance - Flatulence

    Time frame: 9 days

    Daily assessment of presence of flatulence

  6. Daily assessment of gastrointestinal tolerance - Abdominal pain

    Time frame: 9 days

    Daily assessment of abdominal pain

  7. Frequency and nature of adverse events

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 20, 2016
Registry last updated
Oct 21, 2016

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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