Cerebral PalsyNCT05020756
Study in Children Who Have Switched to Isosource Junior Mix Formula
An observational study of Cerebral Palsy, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Isosource Junior Mix
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Mar 2021to 2 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 14 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- All children who are using Isosource Junior Mix as tube feed formula
Who cannot join
- All children who did not switch to Isosource Junior Mix feed formula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Cerebral Palsy
- Being tested
- Isosource Junior Mix
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosource Junior MixDietary supplement
Single arm study, collecting data on those who have been on Isosourcr Junior mix tube feed formula for 30 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding tolerance
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)
Measured: 30 days
Secondary outcomes (2)
Volume consumed
Average volume consumed over month period
Measured: 30 days
Weight in Kg
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start26 Mar 2021
- Primary completion26 Mar 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020756
- Sponsor's protocol ID
- Blend 002
- Status last verified
- Nov 2024
- First submitted
- 28 Apr 2021
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study in Children Who Have Switched to Isosource Junior Mix Formula (RICIMIX Study)
- ClinicalTrials.gov ID
- NCT05020756
- Acronym / sponsor ID
- Blend 002
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- All children who are using Isosource Junior Mix as tube feed formula
Key exclusion criteria (1 listed)
- All children who did not switch to Isosource Junior Mix feed formula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isosource Junior MixSingle arm study, collecting data on those who have been on Isosourcr Junior mix tube feed formula for 30 days | Dietary supplement | – |
Primary outcome
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)
2 secondary outcomes
Volume consumed
Time frame: 30 days
Weight in Kg
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding tolerance (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.