Nutritional Tolerance and Safety of a Tube Feeding Formula in Children
Sponsored by Société des Produits Nestlé (SPN)
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 2 years ago
What is this trial about?
What are the participation requirements?
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.