Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

NCT05838495 | Completed

• 2 other identifiers: N02-20-01-T000422.01.CA.HCN
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Enteral Feeding

Outcome Measures

Primary Outcomes (1)

• Nutritional efficacy - energy

  Percent of daily calorie nutritional goals met

  14 days

Secondary Outcomes (5)

• Nutritional efficacy - protein

  14 days

• Frequency of nausea

  14 days

• Frequency of vomiting

  14 days

• Bristol Stool Chart

  14 days

• Adverse events

  14 days

Study Arms (1)

Enteral tube fed children

EXPERIMENTAL

Children being fed an enteral formula with a feeding tube

Other: formulated liquid diet

Interventions

formulated liquid diet OTHER

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

Enteral tube fed children

Eligibility Criteria

• Age: 1 Year - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single arm, non-randomized, open-label, observational study

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 1, 2023
• Study Start: June 1, 2023
• Primary Completion: July 5, 2024
• Study Completion: July 6, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)