Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 4:10 AM
Study NCT ID:
NCT05058534
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2021-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiperfusion Neonatal System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 640}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of infection', 'timeFrame': 'through study completion, an average of 60 days', 'description': 'Number of infections per 1000 catheter days, per patient during hospital stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': 'Infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. Administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. In critically ill, high risk neonates, use of these systems is associated with complications such as infections, interactions between drugs simultaneously infused on the same route (precipitates, catheter obstruction), less effective treatment due to modified amount of drug administered compared to expected or to compatibility issues between drugs. Sepsis and reduction of treatment efficacy can have an impact on survival or subsequent neurodevelopment. Late onset sepsis is one of the most frequent complications in very premature infants born before 33 weeks gestational age and most of those infections occur in infants requiring a perfusion system and an intravenous catheter.\n\nIn this context, a new multiperfusion device was developed (Multiline Néo®, Doran, France) to remove access to the infusion system from the incubator where high temperature and humidity favour bacterial growth. But also to allow the administration of several drug solutions simultaneously avoiding contact between drugs.\n\nOur hypothesis is that the new perfusion system helps to reduce the risk of infections, without increase in costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants born between November 30, 2018 and December 31, 2022, at a gestational age below 33 weeks, and hospitalized in the Neonatal unit of Croix-Rousse hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born between November 30, 2018 and December 31, 2022,\n* Gestational age below 33 weeks\n\nExclusion Criteria:\n\n* Severe malformation and / or disease requiring heavy surgical management in the neonatal period\n* Admitted at croix rousse hospital after the third day of life'}, 'identificationModule': {'nctId': 'NCT05058534', 'acronym': 'EDELWEISS', 'briefTitle': 'Multiperfusion Neonatal System', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Impact of a New Multiperfusion Neonatal System on Health and Cost of Care in Neonates', 'orgStudyIdInfo': {'id': 'CRC_GHN_2021_004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Very preterm infants born between November 30, 2018 and November 30, 2019', 'description': 'Infants born between November 30, 2018 - November 30, 2019, before implementation of the new multiperfusion neonatal system'}, {'label': 'Very preterm infants born between December 1st, 2019 and December 31st, 2022', 'description': 'Infants born between January 1rst, 2019 - December 31st, 2022, after implementation of the new multiperfusion neonatal system', 'interventionNames': ['Device: Multiline Neo®']}], 'interventions': [{'name': 'Multiline Neo®', 'type': 'DEVICE', 'description': 'Multiperfusion neonatal system', 'armGroupLabels': ['Very preterm infants born between December 1st, 2019 and December 31st, 2022']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Hospices Civil de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}