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NCT05020756 Clinical Trial

Study in Children Who Have Switched to Isosource Junior Mix Formula

Cerebral Palsy Clinical Trial

Official title:
A Retrospective Study In Children Who Have Switched to Isosource Junior Mix Formula (RICIMIX Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05020756
Other study ID # Blend 002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 26, 2021
Est. completion date August 2, 2021

Study information
Verified date March 2021
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Description:

Retrospective data will be collected using questionnaire by the dietitians at the nutrition and dietetic department. All completed questionnaires will be sent back to Nestle Health Science/ CRO company. The primary objectives: 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) - Volume of formula consumed in a day The secondary objective is to collect restropective data on: - Any improved patient outcomes noted - Calculate the potential cost savings made when using ISJMIX to help manage the feeding intolerances - Calculate the potential costs benefit of using ISJMIX over other standard formulas

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date August 2, 2021
Est. primary completion date March 26, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Months to 14 Years
Eligibility Inclusion Criteria: - All children who are using Isosource Junior Mix as tube feed formula Exclusion Criteria: - All children who did not switch to Isosource Junior Mix feed formula

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Isosource Junior Mix
Single arm study, collecting data on those who have been on Isosourcr Junior mix tube feed formula for 30 days

Locations
Country Name City State
United Kingdom Nestle Health Science Gatwick

Sponsors (2)
Lead Sponsor Collaborator
Nestlé Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Volume consumed Average volume consumed over month period 30 days
Secondary Weight in Kg 1 month
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