Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT05020756
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2021-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study in Children Who Have Switched to Isosource Junior Mix Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feeding tolerance', 'timeFrame': '30 days', 'description': 'The following measures will be collected retrospectively after 1 month use of ISJMIX\n\n• Feeding tolerance \\[no change, tolerance improved, tolerance worsened\\]: gastric residuals, gagging/retching, vomiting, abdominal distention/ gas, stool consistency issues (too hard, too loose)'}], 'secondaryOutcomes': [{'measure': 'Volume consumed', 'timeFrame': '30 days', 'description': 'Average volume consumed over month period'}, {'measure': 'Weight in Kg', 'timeFrame': '1 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': '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\n\n* The current usage of ISJMIX formula in children who require blended diets\n* Improved feeding intolerances\n* Improved patient outcomes/ experiences', 'detailedDescription': '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.\n\nThe primary objectives:\n\nThe following measures will be collected retrospectively after 1 month use of ISJMIX\n\n* Feeding tolerance \\[no change, tolerance improved, tolerance worsened\\]: gastric residuals, gagging/retching, vomiting, abdominal distention/ gas, stool consistency issues (too hard, too loose)\n* Volume of formula consumed in a day\n\nThe secondary objective is to collect restropective data on:\n\n* Any improved patient outcomes noted\n* Calculate the potential cost savings made when using ISJMIX to help manage the feeding intolerances\n* Calculate the potential costs benefit of using ISJMIX over other standard formulas'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children who are using Isosource Junior Mix as tube feed formula\n\nExclusion Criteria:\n\n* All children who did not switch to Isosource Junior Mix feed formula'}, 'identificationModule': {'nctId': 'NCT05020756', 'briefTitle': 'Study in Children Who Have Switched to Isosource Junior Mix Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'A Retrospective Study in Children Who Have Switched to Isosource Junior Mix Formula (RICIMIX Study)', 'orgStudyIdInfo': {'id': 'Blend 002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Isosource Junior Mix', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single arm study, collecting data on those who have been on Isosourcr Junior mix tube feed formula for 30 days'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RH6 0PA', 'city': 'Gatwick', 'country': 'United Kingdom', 'facility': 'Nestle Health Science', 'geoPoint': {'lat': 51.16667, 'lon': -0.18333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Great Ormond Street Hospital for Children NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}