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Study in Children Who Have Switched to Isosource Junior Mix Formula

N

Nestlé

Status

Completed

Conditions

Cerebral Palsy

Treatments

Dietary Supplement: Isosource Junior Mix

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05020756
Blend 002

Details and patient eligibility

About

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

Full 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

Enrollment

43 patients

Sex

All

Ages

12 months to 14 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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