Enteral Feeding
Conditions
Brief summary
To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.
Detailed description
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.
Interventions
OTHERformulated liquid diet
will be fed exclusively the pediatric enteral study formula with a feeding tube
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective, single arm, non-randomized, open-label, observational study
Eligibility
Sex/Gender
ALL
Age
1 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional efficacy - energy | 14 days | Percent of daily calorie nutritional goals met |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of vomiting | 14 days | Daily frequency of vomiting for each participant |
| Frequency of nausea | 14 days | Daily frequency of nausea for each participant |
| Nutritional efficacy - protein | 14 days | Percent of daily protein nutritional goals met |
| Bristol Stool Chart | 14 days | 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 |
| Adverse events | 14 days | Daily adverse event reporting |
Countries
Canada
Outcome results
None listed