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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05020756
Enrollment
43
Registered
2021-08-25
Start date
2021-03-26
Completion date
2021-08-02
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

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

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

Interventions

DIETARY_SUPPLEMENTIsosource Junior Mix

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

Sponsors

Great Ormond Street Hospital for Children NHS Foundation Trust
CollaboratorOTHER
Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Months to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feeding tolerance30 daysThe 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)

Secondary

MeasureTime frameDescription
Volume consumed30 daysAverage volume consumed over month period
Weight in Kg1 month

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026