Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

Not Applicable

Completed

• Conditions: Enteral Feeding
• Interventions: Other: formulated liquid diet

• Registration Number: NCT05838495
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-01
• Study Start: 2023-06-01
• Primary Completion: 2024-07-05
• Study Completion: 2024-07-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enteral tube fed children	formulated liquid diet	Children being fed an enteral formula with a feeding tube

Primary Outcome Measures

Name	Time	Method
Nutritional efficacy - energy	14 days	Percent of daily calorie nutritional goals met

Secondary Outcome Measures

Name	Time	Method
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
Frequency of nausea	14 days	Daily frequency of nausea for each participant
Frequency of vomiting	14 days	Daily frequency of vomiting for each participant

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada