Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT04154618
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2019-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Vital Sign Monitoring in Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-19', 'releaseDate': '2025-11-11'}], 'estimatedResultsFirstSubmitDate': '2025-11-11'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM).', 'timeFrame': 'Up to 3 days', 'description': 'TAM questionnaires will be distributed to the nurse taking care of each subject at the time of discharge of the infant. The questionnaire will include informed consent by the nurse for participation in the research. A similar questionnaire will also be distributed to the mother just prior to discharge.'}], 'secondaryOutcomes': [{'measure': 'Accuracy assessed by comparison to conventional vital sign measurements within a 2-minute window', 'timeFrame': 'Up to 3 days', 'description': 'The mean continuous measurements within a 2-minute window around each conventional vital sign assessment (routinely, several in the first 4 hours after birth, and then every 12 hours) will be compared to the routine measurement.'}, {'measure': 'Clinical Utility as measured by false alerts', 'timeFrame': 'Up to 3 days', 'description': 'Quantify false positive alerts and false negative alerts as a measure of potential adverse effect on nursing workflow and patient care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Newborn Complication']}, 'descriptionModule': {'briefSummary': 'This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.', 'detailedDescription': 'This study is conducted for the purposes of understanding the feasibility and acceptability of routine wireless continuous monitoring on healthy newborns as a standard practice \\& its effect on existing workflows and as a future tool for the early detection of undiagnosed problems. All infants will receive routine newborn nursing care .\n\nOnce alarm limits have been determined, the monitoring data will be analyzed in real time and out of range vital signs will alert the nurse to perform standard assessment of the newborn.\n\nNurse and parents will complete surveys regarding their experience with continuous vital sign monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Hours', 'minimumAge': '0 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy newborn infants \\< 12 hours of age admitted to the Well Baby Nursery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infants \\<12 hours of age\n* Expected to be admitted to the Well Baby Nursery\n* 36 or more weeks gestation at birth\n* Mother at least 18 years of age\n\nExclusion Criteria:\n\n* Infants requiring any non-routine medical care or observation\n* Neonatal Intensive Care Unit (NICU) or Special Care Nursery admission\n* Multiple birth'}, 'identificationModule': {'nctId': 'NCT04154618', 'briefTitle': 'Continuous Vital Sign Monitoring in Newborns', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Continuous Vital Sign Monitoring in Newborns', 'orgStudyIdInfo': {'id': '19-0653'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Continuous wireless vital sign monitoring', 'type': 'DEVICE', 'description': 'Infants will receive wireless vital sign monitoring throughout their birth hospitalization.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debra C Potak, RN', 'role': 'CONTACT', 'email': 'dpotak@northwell.edu', 'phone': '516-838-6436'}, {'name': 'Barry Weinberger, MD', 'role': 'CONTACT', 'email': 'bweinberger@northwell.edu', 'phone': '718 470-3440'}, {'name': 'Barry Weinberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Robert I Koppel, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Cohen Children's Medical Center of New York", 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10591', 'city': 'Sleepy Hollow', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mazen T Khalifeh, MD', 'role': 'CONTACT', 'email': 'mkhalifeh@northwell.edu', 'phone': '914-269-1914'}, {'name': 'Mazen T Khalifeh, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Phelps Hospital', 'geoPoint': {'lat': 41.08565, 'lon': -73.85847}}], 'centralContacts': [{'name': 'Barry Weinberger, MD', 'role': 'CONTACT', 'email': 'BWeinberger@northwell.edu', 'phone': '718-470-3440'}, {'name': 'Debra C Potak, RN', 'role': 'CONTACT', 'email': 'DPotak@northwell.edu', 'phone': '516-838-6434'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'Data will become available after enrollment is complete and all data have been collected', 'ipdSharing': 'YES', 'description': 'All individual participant data (IPD).', 'accessCriteria': 'Requests to the principal investigator (PI) to obtain data outlining the purpose of the study, the data elements to be accessed, preferred method of transmission, and preferred file type. For requests of identifiable information or information utilizing a limited data set a copy of valid institutional review board (IRB) approval and informed consent, as applicable. The PI will evaluate the request and ensure that appropriate regulatory approvals have been obtained. Once approved the investigator will be informed and relevant data transferred for analysis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York State Department of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Barry Weinberger', 'investigatorAffiliation': 'Northwell Health'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-11', 'type': 'RELEASE'}, {'date': '2025-11-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Barry Weinberger, Northwell Health, Northwell Health'}}}}