Study in Children Who Have Switched to Isosource Junior Mix Formula

NCT ID: NCT05020756

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-26

Study Completion Date

2021-08-02

Brief Summary

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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

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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

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Cerebral Palsy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Isosource Junior Mix

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nestle Health Science

Gatwick, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Blend 002

Identifier Type: -

Identifier Source: org_study_id

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