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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

N02-20-01-T0004

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
1 to 13 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status

Recruiting