Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
Study NCT ID:
NCT01981057
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2013-11-05
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Experience With Numeta in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nadja.haiden@meduniwien.ac.at', 'phone': '+4314040032320', 'title': 'Nadja Haiden M.D.', 'organization': 'Medical University of Vienna'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Numeta', 'description': 'parenteral receipt prescribed with Numeta\n\nNumeta: parenteral receipt prescribed with Numeta\n\nIndividual: parenteral receipt prescribed individually', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Individual', 'description': 'individually prescribed parenteral receipt\n\nNumeta: parenteral receipt prescribed with Numeta\n\nIndividual: parenteral receipt prescribed individually', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Numeta', 'description': 'parenteral receipt prescribed with Numeta\n\nNumeta: parenteral receipt prescribed with Numeta\n\nIndividual: parenteral receipt prescribed individually'}, {'id': 'OG001', 'title': 'Individual', 'description': 'individually prescribed parenteral receipt\n\nNumeta: parenteral receipt prescribed with Numeta\n\nIndividual: parenteral receipt prescribed individually'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '4.1'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Prescriptions for protein in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations.', 'unitOfMeasure': 'g/kg/d', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Energy', 'timeFrame': '6 weeks', 'description': 'Prescriptions for energy in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Carbohydrates', 'timeFrame': '6 weeks', 'description': 'Prescriptions for carbohydrates in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Fat', 'timeFrame': '6 weeks', 'description': 'Prescriptions for fat in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Sodium', 'timeFrame': '6 weeks', 'description': 'Prescriptions for sodium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Potassium', 'timeFrame': '6 weeks', 'description': 'Prescriptions for Potassium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Calcium', 'timeFrame': '6 weeks', 'description': 'Prescriptions for calcium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Magnesium', 'timeFrame': '6 weeks', 'description': 'Prescriptions for magnesium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Phosphorous', 'timeFrame': '6 weeks', 'description': 'Prescriptions for phosphorous in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Osmolarity', 'timeFrame': '6 weeks', 'description': 'Osmolarity in parenteral nutrition solutions will be calculated individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Numeta', 'description': 'parenteral receipt prescribed with Numeta\n\nNumeta: parenteral receipt prescribed with Numeta\n\nIndividual: parenteral receipt prescribed individually'}, {'id': 'FG001', 'title': 'Individual', 'description': 'individually prescribed parenteral receipt\n\nNumeta: parenteral receipt prescribed with Numeta\n\nIndividual: parenteral receipt prescribed individually'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Numeta', 'description': 'parenteral receipt prescribed with Numeta\n\nNumeta: parenteral receipt prescribed with Numeta\n\nIndividual: parenteral receipt prescribed individually'}, {'id': 'BG001', 'title': 'Individual', 'description': 'individually prescribed parenteral receipt\n\nNumeta: parenteral receipt prescribed with Numeta\n\nIndividual: parenteral receipt prescribed individually'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '233', 'groupId': 'BG000', 'lowerLimit': '189', 'upperLimit': '283'}, {'value': '233', 'groupId': 'BG001', 'lowerLimit': '189', 'upperLimit': '283'}, {'value': '233', 'groupId': 'BG002', 'lowerLimit': '189', 'upperLimit': '283'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days of gestation', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '6 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-25', 'studyFirstSubmitDate': '2013-11-05', 'resultsFirstSubmitDate': '2014-05-10', 'studyFirstSubmitQcDate': '2013-11-05', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-10', 'studyFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protein', 'timeFrame': '6 weeks', 'description': 'Prescriptions for protein in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations.'}], 'secondaryOutcomes': [{'measure': 'Energy', 'timeFrame': '6 weeks', 'description': 'Prescriptions for energy in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations'}, {'measure': 'Carbohydrates', 'timeFrame': '6 weeks', 'description': 'Prescriptions for carbohydrates in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations'}, {'measure': 'Fat', 'timeFrame': '6 weeks', 'description': 'Prescriptions for fat in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations'}, {'measure': 'Sodium', 'timeFrame': '6 weeks', 'description': 'Prescriptions for sodium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations'}, {'measure': 'Potassium', 'timeFrame': '6 weeks', 'description': 'Prescriptions for Potassium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations'}, {'measure': 'Calcium', 'timeFrame': '6 weeks', 'description': 'Prescriptions for calcium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations'}, {'measure': 'Magnesium', 'timeFrame': '6 weeks', 'description': 'Prescriptions for magnesium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations'}, {'measure': 'Phosphorous', 'timeFrame': '6 weeks', 'description': 'Prescriptions for phosphorous in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations'}, {'measure': 'Osmolarity', 'timeFrame': '6 weeks', 'description': 'Osmolarity in parenteral nutrition solutions will be calculated individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['parenteral nutrition', 'Numeta', 'prescription software Cato Pan'], 'conditions': ['Premature Infants']}, 'referencesModule': {'references': [{'pmid': '25655621', 'type': 'DERIVED', 'citation': 'Kreissl A, Repa A, Binder C, Thanhaeuser M, Jilma B, Berger A, Haiden N. Clinical Experience With Numeta in Preterm Infants: Impact on Nutrient Intake and Costs. JPEN J Parenter Enteral Nutr. 2016 May;40(4):536-42. doi: 10.1177/0148607115569733. Epub 2015 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective noninterventional study is to evaluate the clinical application of Numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition. With the prescription software Cato-PAN® (by Cato software solutions) exact valid prescriptions for ordering parenteral nutrition solutions for premature infants are compared. Each PN solution is prescribed individually as well as with Numeta. Prescriptions were mirrored with respect to weight, venous approach, total volume and amount of enteral feeding, 24h medication and flipped vice versa. The key nutrient for calculating Numeta prescriptions was protein. The results of PN prescriptions were compared with each other/ESPGHAN recommendations. The investigators hypothesize that nutrimental content of Numeta prescriptions is equal to individually prescribed .parenteral nutrition solutions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Hour', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'preterm infants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants \\<37 weeks gestational age\n* parenteral nutrition therapy\n\nExclusion Criteria:\n\n* hypersensitivity to egg, soy or peanut proteins or to any of the active substances\n* congenital abnormality of the amino acid metabolism\n* pathogenically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorous\n* severe hyperglycemia\n* severe hyperlipidemia\n* severe disorders of lipid metabolism characterized by hypertriglyceridemia'}, 'identificationModule': {'nctId': 'NCT01981057', 'acronym': 'Numeta', 'briefTitle': 'Clinical Experience With Numeta in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Clinical Experience With Numeta- Impact on Intake of Nutrients and Costs', 'orgStudyIdInfo': {'id': 'MUV-Numeta'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Numeta', 'description': 'parenteral receipt prescribed with Numeta', 'interventionNames': ['Other: Numeta', 'Other: Individual']}, {'label': 'Individual', 'description': 'individually prescribed parenteral receipt', 'interventionNames': ['Other: Numeta', 'Other: Individual']}], 'interventions': [{'name': 'Numeta', 'type': 'OTHER', 'description': 'parenteral receipt prescribed with Numeta', 'armGroupLabels': ['Individual', 'Numeta']}, {'name': 'Individual', 'type': 'OTHER', 'description': 'parenteral receipt prescribed individually', 'armGroupLabels': ['Individual', 'Numeta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Nadja Haiden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.MD', 'investigatorFullName': 'Nadja Haiden,MD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}