To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
27
will be fed exclusively the pediatric enteral study formula with a feeding tube
Hospital for Sick Children
Toronto, Ontario, Canada
Nutritional efficacy - energy
Percent of daily calorie nutritional goals met
Time frame: 14 days
Nutritional efficacy - protein
Percent of daily protein nutritional goals met
Time frame: 14 days
Frequency of nausea
Daily frequency of nausea for each participant
Time frame: 14 days
Frequency of vomiting
Daily frequency of vomiting for each participant
Time frame: 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
Time frame: 14 days
Adverse events
Daily adverse event reporting
Time frame: 14 days
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