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Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

Sponsor
Société des Produits Nestlé (SPN) (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05838495
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
8
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: formulated liquid diet
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, single arm, non-randomized, open-label, observational studyProspective, single arm, non-randomized, open-label, observational study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Single-center, Open-label Study on the Nutritional Adequacy, Tolerability, and Safety of a Tube Feeding Formula in Pediatric Participants
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Enteral tube fed children

Children being fed an enteral formula with a feeding tube

Other: formulated liquid diet
will be fed exclusively the pediatric enteral study formula with a feeding tube

Outcome Measures

Primary Outcome Measures

  1. Nutritional efficacy - energy [14 days]

    Percent of daily calorie nutritional goals met

Secondary Outcome Measures

  1. Nutritional efficacy - protein [14 days]

    Percent of daily protein nutritional goals met

  2. Frequency of nausea [14 days]

    Daily frequency of nausea for each participant

  3. Frequency of vomiting [14 days]

    Daily frequency of vomiting for each participant

  4. Daily stool consistency and stool frequency - Bristol Stool Scale [14 days]

    Daily reporting of stool parameters using Bristol stool scale

  5. Adverse events [14 days]

    Daily adverse event reporting

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Jessie Hulst, MD, The Hospital for Sick Children
  • Study Chair: Cindy Steel, MSc, Nestle Health Science Canada
  • Study Director: Krys Araujo Torres, MD, Nestle Health Science USA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Société des Produits Nestlé (SPN)
ClinicalTrials.gov Identifier:
NCT05838495
Other Study ID Numbers:
  • N02-20-01-T0004
  • 22.01.CA.HCN
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 1, 2023