Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

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

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.

Official Title
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A Single-center, Open-label Study on the Nutritional Adequacy, Tolerability, and Safety of a Tube Feeding Formula in Pediatric Participants

Conditions
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Enteral Feeding

Intervention / Treatment
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* Other: formulated liquid diet


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single arm, non-randomized, open-label, observational study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteral tube fed children<br>Children being fed an enteral formula with a feeding tube | Other: formulated liquid diet<br>* will be fed exclusively the pediatric enteral study formula with a feeding tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional efficacy - energy | Percent of daily calorie nutritional goals met | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional efficacy - protein | Percent of daily protein nutritional goals met | 14 days | 
| Frequency of nausea | Daily frequency of nausea for each participant | 14 days | 
| Frequency of vomiting | Daily frequency of vomiting for each participant | 14 days | 
| Bristol Stool Chart | Daily reporting of stool parameters using Bristol stool chart. Scale from 1-7. Type 1: Separate hard lumps (hard to pass) Type 2: Lumpy, hard, sausage-shaped Type 3: Sausage-shaped with cracks on the surface Type 4: Sausage-shaped or snake-like; smooth and soft Type 5: Soft blobs with clear-cut edges (easy to pass) Type 6: Fluffy pieces with ragged edges; mushy Type 7: Entirely liquid, watery, no solid pieces | 14 days | 
| Adverse events | Daily adverse event reporting | 14 days |