Raw JSON
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{'pointOfContact': {'email': 'Anup.Katheria@sharp.com', 'phone': '858-939-4170', 'title': 'Dr. Anup Katheria', 'organization': 'Sharp Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'birth to 10 minutes of life', 'description': 'Research/clinical staff collected information about resuscitation interventions for each participant at the time of birth', 'eventGroups': [{'id': 'EG000', 'title': 'iRes Warmer With ResusView', 'description': 'iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer with ResusView: Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 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with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer with ResusView: Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}, {'id': 'OG001', 'title': 'iRes Warmer Without ResusView', 'description': 'An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '11', 'groupId': 'OG000'}, {'value': '50', 'spread': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Measure time from birth to heart rate displayed on monitor following lead placement', 'unitOfMeasure': 'seconds from time of birth', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All with available electrocardiogram data and prenatal consent'}, {'type': 'SECONDARY', 'title': 'Time to First Change in Fraction of Inspired Oxygen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iRes Warmer With ResusView', 'description': 'iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer with ResusView: Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}, {'id': 'OG001', 'title': 'iRes Warmer Without ResusView', 'description': 'An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'spread': '140', 'groupId': 'OG000'}, {'value': '175', 'spread': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Measure time from birth to first increase or decrease in fraction of inspired oxygen from ECG lead placement', 'unitOfMeasure': 'seconds from time of birth', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all subject with available electrocardiogram and fraction of inspired oxygen with consent prior to birth'}, {'type': 'SECONDARY', 'title': 'Time to First Change in Airway Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iRes Warmer With ResusView', 'description': 'iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer with ResusView: Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}, {'id': 'OG001', 'title': 'iRes Warmer Without ResusView', 'description': 'An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}], 'classes': [{'categories': [{'measurements': [{'value': '215', 'spread': '204', 'groupId': 'OG000'}, {'value': '100', 'spread': '69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Measure time from birth to first increase or decrease in airway pressure from ECG lead placement', 'unitOfMeasure': 'seconds from time of birth', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Initiation of Positive Pressure Ventilation (PPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iRes Warmer With ResusView', 'description': 'iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer with ResusView: Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}, {'id': 'OG001', 'title': 'iRes Warmer Without ResusView', 'description': 'An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '22', 'groupId': 'OG000'}, {'value': '139', 'spread': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Measure time from birth to start of PPV following first heart rate display', 'unitOfMeasure': 'seconds from time of birth', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all with available electrocardiogram data and resuscitation intervention details'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time of Electrode Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iRes Warmer With ResusView', 'description': 'iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer with ResusView: Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}, {'id': 'OG001', 'title': 'iRes Warmer Without ResusView', 'description': 'An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'spread': '24', 'groupId': 'OG000'}, {'value': '112', 'spread': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Measure time from birth to application of Electrocardiogram electrodes from time of birth', 'unitOfMeasure': 'seconds from time of birth', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all with electrocardiogram lead placement during resuscitation'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EKG Waveform Displayed by Rapid EKG Algorithm During Resuscitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iRes Warmer With ResusView', 'description': 'iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer with ResusView: Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}, {'id': 'OG001', 'title': 'iRes Warmer Without ResusView', 'description': 'An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Identify if a cardiac rhythm is recognized by Electrocardiogram monitor algorithm and displays a waveform during resuscitation (Yes/No)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all with electrocardiogram lead placement'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Rhythm Recognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iRes Warmer With ResusView', 'description': 'iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer with ResusView: Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}, {'id': 'OG001', 'title': 'iRes Warmer Without ResusView', 'description': 'An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'spread': '28', 'groupId': 'OG000'}, {'value': '161', 'spread': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth to 10 minutes of life', 'description': "Measure at what time the Warmer displays the baby's cardiac rhythm", 'unitOfMeasure': 'seconds from time of EKG lead placement', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all with electrocardiogram data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'iRes Warmer With ResusView', 'description': 'iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer with ResusView: Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}, {'id': 'FG001', 'title': 'iRes Warmer Without ResusView', 'description': 'An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Pregnant women who are dated by their earliest ultrasound scan or last menstrual period at 230/7 to 326/7 weeks of gestational age were identified, recruited, and consented from the labor and delivery floor or perinatal special care unit at Sharp Mary Birch Hospital Women \\& Newborns from February 2021 through June 2021.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'iRes Warmer With ResusView', 'description': 'iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer with ResusView: Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}, {'id': 'BG001', 'title': 'iRes Warmer Without ResusView', 'description': 'An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.\n\niRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'spread': '3', 'groupId': 'BG000'}, {'value': '28', 'spread': '3', 'groupId': 'BG001'}, {'value': '28', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks gestational age at birth', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex assigned at birth', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'all consented and enrolled in study'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2021-03-16', 'size': 227442, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-20T16:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2020-10-02', 'resultsFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2020-10-08', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-19', 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time of Electrode Placement', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Measure time from birth to application of Electrocardiogram electrodes from time of birth'}, {'measure': 'EKG Waveform Displayed by Rapid EKG Algorithm During Resuscitation', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Identify if a cardiac rhythm is recognized by Electrocardiogram monitor algorithm and displays a waveform during resuscitation (Yes/No)'}, {'measure': 'Time to Rhythm Recognition', 'timeFrame': 'Birth to 10 minutes of life', 'description': "Measure at what time the Warmer displays the baby's cardiac rhythm"}], 'primaryOutcomes': [{'measure': 'Time to Heart Rate Display in iRes Warmer With Resusview', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Measure time from birth to heart rate displayed on monitor following lead placement'}], 'secondaryOutcomes': [{'measure': 'Time to First Change in Fraction of Inspired Oxygen', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Measure time from birth to first increase or decrease in fraction of inspired oxygen from ECG lead placement'}, {'measure': 'Time to First Change in Airway Pressure', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Measure time from birth to first increase or decrease in airway pressure from ECG lead placement'}, {'measure': 'Time to Initiation of Positive Pressure Ventilation (PPV)', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Measure time from birth to start of PPV following first heart rate display'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['electrocardiogram', 'Neonatal Resuscitation', 'resuscitation of premature infants'], 'conditions': ['Premature Infant', 'Extremely Low Birth Weight', 'Extreme Prematurity']}, 'referencesModule': {'references': [{'pmid': '29099872', 'type': 'BACKGROUND', 'citation': 'Katheria A, Arnell K, Brown M, Hassen K, Maldonado M, Rich W, Finer N. A pilot randomized controlled trial of EKG for neonatal resuscitation. PLoS One. 2017 Nov 3;12(11):e0187730. doi: 10.1371/journal.pone.0187730. eCollection 2017.'}, {'pmid': '32102255', 'type': 'BACKGROUND', 'citation': 'Johnson PA, Schmolzer GM. Heart Rate Assessment during Neonatal Resuscitation. Healthcare (Basel). 2020 Feb 23;8(1):43. doi: 10.3390/healthcare8010043.'}, {'type': 'BACKGROUND', 'citation': 'Neonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of Pediatrics.'}, {'pmid': '34715091', 'type': 'DERIVED', 'citation': 'Katheria AC, Morales A, Shashank S, Rich WD, Finer NN. A Pilot Randomized Trial of Heart Rate Monitoring Using Conventional Versus a New Electrocardiogram Algorithm during Neonatal Resuscitation at Birth. J Pediatr. 2022 Mar;242:245-247.e1. doi: 10.1016/j.jpeds.2021.10.037. Epub 2021 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g. Cardiopulmonary resuscitation or breathing assistance) of premature newborns (23 to 32+6 weeks gestation).', 'detailedDescription': "This is a prospective interventional randomized control trial. Infants born between 23+0 and 32+6 estimated gestational age will be randomized using a computer generate allocation sequence stratified by gestational age. Randomization cards will be placed in opaque envelopes. For the intervention group, the care team will use the Panda iRes Warmer with ResusView Bed during resuscitation interventions in the first 10 minutes of life. During use of the iRes-warmer, standard nursing care of an infant on a radiant warmer will be followed. Participants assigned to the control group will receive interventions using the same model Panda bed without ResusView. There is no minimum time for monitoring, and the maximum time depends on clinical determination for use of heart rate feature for each resuscitation event. Data including the infant's gestational age, Electrocardiogram lead type and activities that occurred during resuscitation will be recorded for the first 10 minutes of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '23 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants who are delivered to mothers over the age of 16 years of age\n* Infants delivered at 23+0 to 32+6 weeks estimated gestational age based on the best obstetric estimate at the time of delivery.\n* Infants without known congenital malformations prior to delivery\n* Antenatal consent\n\nExclusion Criteria:\n\n* Infants who are delivered to mothers under the age of 16 years of age\n* Known congenital anomalies of newborn prior to delivery\n* Cardiac defects other than small Ventricular septum defect and Patent ductus arteriosus\n* Multiples\n* Declined consent\n* iRes Warmer with ResusView not available at time of delivery'}, 'identificationModule': {'nctId': 'NCT04587934', 'acronym': 'GE-EKG', 'briefTitle': 'Time to Accurate Heart Rate on Neonatal Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'Time to Accurate Heart Rate on Neonatal Outcomes', 'orgStudyIdInfo': {'id': 'GE-EKG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iRes Warmer with ResusView', 'description': 'iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.', 'interventionNames': ['Device: iRes Warmer with ResusView']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'iRes Warmer without ResusView', 'description': 'An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.', 'interventionNames': ['Other: iRes Warmer without ResusView']}], 'interventions': [{'name': 'iRes Warmer with ResusView', 'type': 'DEVICE', 'otherNames': ['Panda Bed with ECG Feature'], 'description': 'Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age', 'armGroupLabels': ['iRes Warmer with ResusView']}, {'name': 'iRes Warmer without ResusView', 'type': 'OTHER', 'otherNames': ['Standard of Care'], 'description': 'Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age', 'armGroupLabels': ['iRes Warmer without ResusView']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Mary Birch Hospital for Women and Newborns', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Anup Katheria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sharp HealthCare'}]}, 'ipdSharingStatementModule': {'url': 'https://pubmed.ncbi.nlm.nih.gov/34715091/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 6 months and ending 36 months following article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data, particularly data that underlie the results reported in this article after deidentification will be available with other researchers, including data dictionaries for meta-analysis.', 'accessCriteria': 'Data and publication are available at clinicaltrials.gov'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharp HealthCare', 'class': 'OTHER'}, 'collaborators': [{'name': 'GE Healthcare', 'class': 'INDUSTRY'}, {'name': 'Sharp Mary Birch Hospital for Women & Newborns', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}