Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

Nestlé

Status

Completed

Conditions

Enteral Feeding

Treatments

Other: formulated liquid diet

Study type

Interventional

Funder types

Industry

Identifiers

NCT05838495

N02-20-01-T0004

22.01.CA.HCN (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

27 patients

Sex

All

Ages

1 to 13 years old

Volunteers

No Healthy Volunteers

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.