Enteral Formula Tolerance in Pediatric Patients

Enteral Nutrition Clinical Trial

Official title:

Enteral Formula Tolerance in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779335
• Other study ID #: 15.09.US.HCN
• Status: Completed
• Phase: N/A
• First received: March 18, 2016
• Last updated: October 20, 2016
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2016
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 13 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

Other:
• Enteral Formula
pediatric subjects will be fed a standard pediatric enteral formula tube feeding

Locations

Country	Name	City	State
United States	Children's Center for GI and Nutrition	Hollywood	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily percentage of caloric nutritional goal met		9 days	No
Secondary	Daily percentage of protein goal met		9 days	No
Secondary	Daily assessment of gastrointestinal tolerance - stool consistency	Daily assessment of stool consistency (liquid, formed, soft)	9 days	No
Secondary	Daily assessment of gastrointestinal tolerance- Stool frequency	Daily assessment of number of stool	9 days	No
Secondary	Daily assessment of gastrointestinal tolerance- Vomit	Daily assessment of frequency of vomit	9 days	No
Secondary	Daily assessment of gastrointestinal tolerance - Flatulence	Daily assessment of presence of flatulence	9 days	No
Secondary	Daily assessment of gastrointestinal tolerance - Abdominal pain	Daily assessment of abdominal pain	9 days	No
Secondary	Frequency and nature of adverse events		9 days	Yes