NCT05020756

Study in Children Who Have Switched to Isosource Junior Mix Formula

A Retrospective Study in Children Who Have Switched to Isosource Junior Mix Formula (RICIMIX Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 12 Months – 14 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-26
• Primary completion: 2021-03-26
• Completion: 2021-08-02
• First posted: 2021-08-25
• Last updated: 2024-11-06

Locations

1 site across 1 country: United Kingdom