Study in Children Who Have Switched to Isosource Junior Mix Formula

November 4, 2024 updated by: Société des Produits Nestlé (SPN)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Gatwick, United Kingdom, RH6 0PA
        • Nestle Health Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding tolerance
Time Frame: 30 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume consumed
Time Frame: 30 days
Average volume consumed over month period
30 days
Weight in Kg
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Collaborators

Great Ormond Street Hospital for Children NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Actual)

March 26, 2021

Study Completion (Actual)

August 2, 2021

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Blend 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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