Nutritional Tolerance and Safety of a Tube Feeding Formul... | NCT05838495

Studies
Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

NCT05838495

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Nov 6, 2024Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Enteral Feeding

Interventions

formulated liquid diet

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
22.01.CA.HCN	Other Identifier	Sponsor

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Jul 5, 2024Actual

Completion Date

Jul 6, 2024Actual

First Submitted Date

Apr 5, 2023

First Submission Date that Met QC Criteria

Apr 28, 2023

First Posted Date

May 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2024

Last Update Posted Date

Nov 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enteral tube fed children	Experimental	Children being fed an enteral formula with a feeding tube	Other: formulated liquid diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
formulated liquid diet	Other	will be fed exclusively the pediatric enteral study formula with a feeding tube	Enteral tube fed children

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nutritional efficacy - energy	Percent of daily calorie nutritional goals met	14 days

Secondary Outcomes

Measure	Description	Time Frame
Nutritional efficacy - protein	Percent of daily protein nutritional goals met	14 days
Frequency of nausea	Daily frequency of nausea for each participant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided