Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT05020756
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2021-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study in Children Who Have Switched to Isosource Junior Mix Formula
Sponsor:
Société des Produits Nestlé (SPN)
Organization:
Study Overview
Official Title:
A Retrospective Study in Children Who Have Switched to Isosource Junior Mix Formula (RICIMIX Study)
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: