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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cerebral Palsy

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