Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

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

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-07-06

Brief Summary

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To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.

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Detailed Description

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The purpose of this study is to assess the efficacy (ability to meet prescribed calorie and protein needs), tolerance, and safety of a pediatric enteral formula (i.e., the study product) in participants aged 1-13 years for 14 days of use.

Conditions

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Enteral Feeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single arm, non-randomized, open-label, observational study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Enteral tube fed children

Children being fed an enteral formula with a feeding tube

Group Type EXPERIMENTAL

formulated liquid diet

Intervention Type OTHER

will be fed exclusively the pediatric enteral study formula with a feeding tube

Interventions

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formulated liquid diet

will be fed exclusively the pediatric enteral study formula with a feeding tube

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Medically stable, enterally tube-fed children
* Aged 1 to 13 years (inclusive) at the time of screening.
* Currently tolerating enteral feeding and should be appropriate for study formula
* Requires enteral tube feeding to provide 90% or more of their nutritional needs
* signed informed consent

Exclusion Criteria

* Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
* Currently using or has previously used the study product
* Any medical condition or contraindicated medications that would contraindicate use of the study product
* Any illness within \~5-7 days of screening and/or baseline lasting \>48 hours and assessed by the PI to have affected nutritional intake on a case-by-case basis.
* Participation in another interventional clinical study
* Any condition or abnormality that, in the opinion of the PI, would compromise the safety of the participant or the quality of the study data.

Minimum Eligible Age

1 Year

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No