Nutritional Tolerance and Safety of a Tube Feeding Formula in Children (NCT05838495) | Clinical Trial Compass
CompletedNot Applicable
Nutritional Tolerance and Safety of a Tube Feeding Formula in Children
Canada27 participantsStarted 2023-06-01
Plain-language summary
To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.
Who can participate
Age range1 Year – 13 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.