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Completed

NCT Number: NCT05020756

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) 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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

12 month–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nestle Health Science

Gatwick, RH6 0PA, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isosource Junior Mix

Dietary Supplement

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Volume consumed

    Time frame: 30 days

    Average volume consumed over month period

  2. Weight in Kg

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2021
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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