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Completed

NCT Number: NCT05838495

Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

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

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Key information

Conditions

Enteral Feeding

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

formulated liquid diet

Other

will be fed exclusively the pediatric enteral study formula with a feeding tube

Primary outcomes

  1. Nutritional efficacy - energy

    Time frame: 14 days

    Percent of daily calorie nutritional goals met

Secondary outcomes

  1. Nutritional efficacy - protein

    Time frame: 14 days

    Percent of daily protein nutritional goals met

  2. Frequency of nausea

    Time frame: 14 days

    Daily frequency of nausea for each participant

  3. Frequency of vomiting

    Time frame: 14 days

    Daily frequency of vomiting for each participant

  4. Bristol Stool Chart

    Time frame: 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

  5. Adverse events

    Time frame: 14 days

    Daily adverse event reporting

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

A Single-center, Open-label Study on the Nutritional Adequacy, Tolerability, and Safety of a Hypercaloric, Plant-based, Real Food Ingredient Formula for Tube Fed Pediatric Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 1, 2023
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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