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Study in Children Who Have Switched to Isosource Junior Mix Formula

Sponsor
Nestlé (Industry)
Overall Status
Completed
CT.gov ID
NCT05020756
Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust (Other)
43
Enrollment
1
Location
4.2
Actual Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Isosource Junior Mix

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 Design

Study Type:
Observational
Actual Enrollment :
43 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
A Retrospective Study In Children Who Have Switched to Isosource Junior Mix Formula (RICIMIX Study)
Actual Study Start Date :
Mar 26, 2021
Actual Primary Completion Date :
Mar 26, 2021
Actual Study Completion Date :
Aug 2, 2021

Outcome Measures

Primary Outcome Measures

  1. Feeding tolerance [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)

Secondary Outcome Measures

  1. Volume consumed [30 days]

    Average volume consumed over month period

  2. Weight in Kg [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Months to 14 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nestle Health Science Gatwick United Kingdom RH6 0PA

Sponsors and Collaborators

  • Nestlé
  • Great Ormond Street Hospital for Children NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nestlé
ClinicalTrials.gov Identifier:
NCT05020756
Other Study ID Numbers:
  • Blend 002
First Posted:
Aug 25, 2021
Last Update Posted:
Aug 25, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cerebral Palsy

Study Results

No Results Posted as of Aug 25, 2021