Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT05250102
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2022-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Neonatal Pulse Oximetry Sensor Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jjfinley@medline.com', 'phone': '(800) 633-5463', 'title': 'Julie J. Finley', 'organization': 'Medline Industries, LP'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Neonates enrolled in the study were monitored until discharge from the hospital, on average for 2 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Pulse Oximeter Sensor Readings', 'description': "Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate.\n\nPulse oximeter sensors: Pulse oximeter reading will be compared to CO-oximeter reading.", 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bland-Altman Analysis for Nellcor Pulse Oximeter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensor Massimo or Nellcor', 'description': 'Each participant wore massimo and nellcor sensors at the same time. Readings were taken from each sensor.'}], 'classes': [{'title': 'Bias Massimo', 'categories': [{'measurements': [{'value': '.151', 'groupId': 'OG000', 'lowerLimit': '-.361', 'upperLimit': '.662'}]}]}, {'title': 'Bias Nellcor', 'categories': [{'measurements': [{'value': '.434', 'groupId': 'OG000', 'lowerLimit': '-.149', 'upperLimit': '1.017'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 episodic minutes', 'description': 'BIAS Measurement and 95% confidence interval calculated using a Bland-Altman plot (mean vs. difference of SaO2 and SpO2) and an error plot (SaO2 vs. difference of SaO2 and SpO2) were generated. The B\\&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot. We ran a percentage mean difference plot.', 'unitOfMeasure': 'percentage of difference in mean', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'all neonates participating in the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pulse Oximeter Sensor Readings', 'description': "Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate.\n\nPulse oximeter sensors: Pulse oximeter reading will be compared to CO-oximeter reading."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'a total of 23 neonates were recruited for the study, with 1-3 measurement pairs taken for each subject and each pulse oximetry sensor, for a total of 2, 4, or 6 measurement pairs per subject.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pulse Oximeter Sensor Readings', 'description': "Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate.\n\nPulse oximeter sensors: Pulse oximeter reading will be compared to CO-oximeter reading."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'spread': '1.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'White - Non Hispanic or Latino', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '23 to 29 weeks'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-09', 'size': 3042204, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-02T10:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2022-02-10', 'resultsFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-29', 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bland-Altman Analysis for Nellcor Pulse Oximeter', 'timeFrame': '15 episodic minutes', 'description': 'BIAS Measurement and 95% confidence interval calculated using a Bland-Altman plot (mean vs. difference of SaO2 and SpO2) and an error plot (SaO2 vs. difference of SaO2 and SpO2) were generated. The B\\&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot. We ran a percentage mean difference plot.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Premature Birth']}, 'referencesModule': {'references': [{'pmid': '29771822', 'type': 'BACKGROUND', 'citation': 'Ascha M, Bhattacharyya A, Ramos JA, Tonelli AR. Pulse Oximetry and Arterial Oxygen Saturation during Cardiopulmonary Exercise Testing. Med Sci Sports Exerc. 2018 Oct;50(10):1992-1997. doi: 10.1249/MSS.0000000000001658.'}, {'pmid': '17185428', 'type': 'BACKGROUND', 'citation': "Dawson JA, Davis PG, O'Donnell CP, Kamlin CO, Morley CJ. Pulse oximetry for monitoring infants in the delivery room: a review. Arch Dis Child Fetal Neonatal Ed. 2007 Jan;92(1):F4-7. doi: 10.1136/adc.2006.102749. No abstract available."}, {'pmid': '17613642', 'type': 'BACKGROUND', 'citation': 'Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat. 2007;17(4):571-82. doi: 10.1080/10543400701329422.'}]}, 'descriptionModule': {'briefSummary': "To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.", 'detailedDescription': 'Pulse oximetry helps in measuring peripheral capillary oxygen saturation (SpO2) continuously and non-invasively, and provides an indirect measurement of arterial oxygenation (SaO2) based on the red and infrared light-absorption characteristics of oxygenated and deoxygenated hemoglobin. Uses of pulse oximetry include detection of hypoxia, avoidance of hyperoxia, titration of fractional inspired oxygen, and enabling weaning from mechanical ventilation. Arterial blood gas (ABG) analysis, such as by the use of CO-oximeter, provides a direct measurement of SaO2. However, ABG analysis requires time, expense, and arterial access. Therefore, this study aims to validate the SpO2 accuracy of pulse oximetry sensors (manufactured by Nellcor and Masimo, and reprocessed by Medline Industries, LP) in neonates as compared to ABG measurements as part of their clinical standard of care (SOC), as assessed by CO-oximetry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are postnatal 28 days or younger (neonates)\n* Subjects who are likely to receive one or more ABG measurements as part of their clinical SOC\n* Subjects who weigh less than 5 Kg (weight range for thesensors)\n\nExclusion Criteria:\n\n* Subjects with current signs and symptoms of a clinically significant Patent Ductus Arteriosus (PDA) combined with a current or planned arterial line placement which will affect the validity of the co-oximetry measurement\n* Subjects with physical malformation of hands, fingers, feet, or toes that would limit the ability to place sensors for this study\n* Subjects judged by the Principal Investigator (PI) to be inappropriate for participation in this study\n* Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g. allergic to foam rubber or adhesive tape)'}, 'identificationModule': {'nctId': 'NCT05250102', 'briefTitle': 'Neonatal Pulse Oximetry Sensor Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medline Industries'}, 'officialTitle': 'Accuracy and Precision of Peripheral Capillary Oxygen Saturation of Reprocessed Pulse Oximetry Sensors Compared to Oxygen Saturation in Arterial Blood Samples Assessed by CO-oximetry in Neonates', 'orgStudyIdInfo': {'id': 'MED-2020-DIV65-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pulse oximeter sensor readings', 'description': "Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate.", 'interventionNames': ['Device: Pulse oximeter sensors']}], 'interventions': [{'name': 'Pulse oximeter sensors', 'type': 'DEVICE', 'description': 'Pulse oximeter reading will be compared to CO-oximeter reading.', 'armGroupLabels': ['Pulse oximeter sensor readings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Eastern Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medline Industries', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}