Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05910320
Status:
TERMINATED
Last Update Posted:
2025-07-10
First Post:
2023-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Closed at site. Investigator no longer at site.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signal morphology of wearable monitoring device', 'timeFrame': 'From device placement to removal, up to 1 hour', 'description': 'Feasibility of a wearable monitoring device as determined by signal morphology of wearable monitoring device'}, {'measure': 'Signal-to-noise ratio of wearable monitoring device', 'timeFrame': 'From device placement to removal, up to 1 hour', 'description': 'Feasibility of a wearable monitoring device as determined by signal-to-noise ratio'}, {'measure': 'Signal-to-noise ratio of reusable electrodes', 'timeFrame': 'From electrode placement to removal, up to 15 minutes', 'description': 'Feasibility of reusable electrodes as determined by the signal-to-noise ratio'}, {'measure': 'Percent error of wearable monitoring device compared to clinical bedside monitors', 'timeFrame': 'From device placement to removal, up to 1 hour', 'description': 'Feasibility of a wearable monitoring device as determined by percent error compared to clinical bedside monitors'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease in Children']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants.', 'detailedDescription': 'Vital sign monitoring of infants outside of a traditional healthcare setting has already been shown to significantly decrease mortality for children with single ventricle congenital heart disease (1V CHD), a fragile group of patients with congenital heart disease (CHD). Therefore, there is a critical need to develop an accurate, at-home vital sign monitoring system for infants to expand the benefits of remote monitoring to further patient populations. The investigators believe that allowing for continuous monitoring at a clinical standard with interpretations and alerts built into the technology will result in an even greater decline in mortality for infants with 1V CHD, improved clinical outcomes for all infants with CHD, and increased well-being for healthy infants.\n\nTo achieve this goal, the investigators are developing a health monitoring system that collects numerical data and physiological waveforms describing heart rate (HR), respiratory rate (RR), pulse oximetry (SpO2), regional oxygen saturation, temperature, and infant motion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (PCICU), or pediatric care unit (PCU)\n* Parent provided written informed consent\n\nExclusion Criteria:\n\n* Foster or ward of the state'}, 'identificationModule': {'nctId': 'NCT05910320', 'briefTitle': 'Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants', 'orgStudyIdInfo': {'id': 'IRB00361015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wearable Vital Signs Monitoring Device', 'interventionNames': ['Device: Wearable Vital Signs Monitoring Device']}], 'interventions': [{'name': 'Wearable Vital Signs Monitoring Device', 'type': 'DEVICE', 'description': 'The prototype will be used to non-invasively measure vital signs. This prototype (preliminary version) is composed of a sensor module, a rechargeable battery, and electrodes. The device is housed in a waterproof, silicone casing.', 'armGroupLabels': ['Wearable Vital Signs Monitoring Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': "Johns Hopkins Children's Center", 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Danielle Gottlieb Sen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}