Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-04-23 @ 9:02 AM
Study NCT ID:
NCT03120702
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2018-05-31', 'completionDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2017-04-14', 'dispFirstSubmitQcDate': '2018-05-31', 'studyFirstSubmitQcDate': '2017-04-18', 'dispFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants', 'timeFrame': 'duration of surgery', 'description': 'To study the SpHb sensor in neonatal population.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female newborn infants of any gestational age requiring at least one (1) blood draw as part of their routine care.\n* Ages: Newborn infants less than 16 weeks postnatal age.\n* Weight: Range from 500 g to 10 kg.\n* Able to obtain written informed consent from parents or legal guardians\n\nExclusion Criteria:\n\n* Neonatal patients with abnormalities at the planned application sites that would interfere with transilluminating the foot or hand like unusual deformities of limbs, absence of feet, severe edema, localized infections, and other.'}, 'identificationModule': {'nctId': 'NCT03120702', 'briefTitle': 'Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'officialTitle': 'Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population', 'orgStudyIdInfo': {'id': 'CHOC0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neonatal Test Subjects', 'description': 'All test subjects in this group are neonatal patients who will receive a investigational Rainbow SpHb sensor.', 'interventionNames': ['Device: Investigational Rainbow SpHb sensor']}], 'interventions': [{'name': 'Investigational Rainbow SpHb sensor', 'type': 'DEVICE', 'description': 'Investigational Rainbow SpHb sensor', 'armGroupLabels': ['Neonatal Test Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}