Study in Children Who Have Switched to Isosource Junior Mix Formula

NCT05020756 | Completed

• 1 other identifier: Blend 002
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

A Retrospective study In Children who have switched to Isosource Junior Mix formula (RICIMIX study) will review paediatric children \> 12 months of age who require Isosource Junior Mix as an enteral tube feeding formula and have consumed the formula for at least 1 month. The purpose of this study is to understand If there has been an improvement in outcomes/ experiences

• The current usage of ISJMIX formula in children who require blended diets
• Improved feeding intolerances
• Improved patient outcomes/ experiences

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Feeding tolerance

  The following measures will be collected retrospectively after 1 month use of ISJMIX • Feeding tolerance \[no change, tolerance improved, tolerance worsened\]: gastric residuals, gagging/retching, vomiting, abdominal distention/ gas, stool consistency issues (too hard, too loose)

  30 days

Secondary Outcomes (2)

• Volume consumed

  30 days

• Weight in Kg

  1 month

Interventions

Isosource Junior Mix DIETARY_SUPPLEMENT

Single arm study, collecting data on those who have been on Isosourcr Junior mix tube feed formula for 30 days

Eligibility Criteria

• Age: 12 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Paediatric children \> 12 months of age who require Isosource Junior Mix as an enteral tube feeding formula and have consumed the formula for at least 1 month

You may qualify if:

• All children who are using Isosource Junior Mix as tube feed formula

You may not qualify if:

• All children who did not switch to Isosource Junior Mix feed formula

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator

Study Sites (1)

Nestle Health Science

Gatwick, RH6 0PA, United Kingdom

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: August 25, 2021
• Study Start: March 26, 2021
• Primary Completion: March 26, 2021
• Study Completion: August 2, 2021
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)