Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT00307333
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2006-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Heart Rate Characteristics Monitoring in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rm3h@virginia.edu', 'phone': '434-982-3367', 'title': 'Joseph R. Moorman, MD', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '120 days follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.', 'otherNumAtRisk': 1500, 'otherNumAffected': 0, 'seriousNumAtRisk': 1500, 'seriousNumAffected': 122}, {'id': 'EG001', 'title': 'Control', 'description': 'Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.', 'otherNumAtRisk': 1489, 'otherNumAffected': 0, 'seriousNumAtRisk': 1489, 'seriousNumAffected': 152}], 'seriousEvents': [{'term': 'Mortality [120 days]', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 122, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 1489, 'numEvents': 152, 'numAffected': 152}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Ventilator-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1500', 'groupId': 'OG000'}, {'value': '1489', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.9', 'spread': '35.1', 'groupId': 'OG000'}, {'value': '93.6', 'spread': '37.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '120 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1511', 'groupId': 'OG000'}, {'value': '1492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '58.7', 'spread': '34.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '120 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days on Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1500', 'groupId': 'OG000'}, {'value': '1489', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '120 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1500', 'groupId': 'OG000'}, {'value': '1489', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.99', 'estimateComment': 'HR = hazard for intervention / hazard for control', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '120 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1511'}, {'groupId': 'FG001', 'numSubjects': '1492'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1500'}, {'groupId': 'FG001', 'numSubjects': '1489'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1511', 'groupId': 'BG000'}, {'value': '1492', 'groupId': 'BG001'}, {'value': '3003', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1511', 'groupId': 'BG000'}, {'value': '1492', 'groupId': 'BG001'}, {'value': '3003', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'spread': '0.054', 'groupId': 'BG000'}, {'value': '0.54', 'spread': '0.054', 'groupId': 'BG001'}, {'value': '0.54', 'spread': '0.054', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'correct as reported', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '791', 'groupId': 'BG000'}, {'value': '767', 'groupId': 'BG001'}, {'value': '1558', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '720', 'groupId': 'BG000'}, {'value': '725', 'groupId': 'BG001'}, {'value': '1445', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1511', 'groupId': 'BG000'}, {'value': '1492', 'groupId': 'BG001'}, {'value': '3003', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3003}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-16', 'studyFirstSubmitDate': '2006-03-24', 'resultsFirstSubmitDate': '2012-04-03', 'studyFirstSubmitQcDate': '2006-03-24', 'lastUpdatePostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-01', 'studyFirstPostDateStruct': {'date': '2006-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Ventilator-free Days', 'timeFrame': '120 days'}], 'secondaryOutcomes': [{'measure': 'Duration of Hospital Stay', 'timeFrame': '120 days'}, {'measure': 'Days on Antibiotics', 'timeFrame': '120 days'}, {'measure': 'Mortality', 'timeFrame': '120 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['very low birth weight infants', 'heart rate characteristics'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '34798080', 'type': 'DERIVED', 'citation': "King WE, Carlo WA, O'Shea TM, Schelonka RL; HRC neurodevelopmental follow-up investigators. Multivariable Predictive Models of Death or Neurodevelopmental Impairment Among Extremely Low Birth Weight Infants Using Heart Rate Characteristics. J Pediatr. 2022 Mar;242:137-144.e4. doi: 10.1016/j.jpeds.2021.11.026. Epub 2021 Nov 17."}, {'pmid': '34247026', 'type': 'DERIVED', 'citation': "King WE, Carlo WA, O'Shea TM, Schelonka RL; HRC neurodevelopmental follow-up investigators. Heart rate characteristics monitoring and reduction in mortality or neurodevelopmental impairment in extremely low birthweight infants with sepsis. Early Hum Dev. 2021 Aug;159:105419. doi: 10.1016/j.earlhumdev.2021.105419. Epub 2021 Jul 4."}, {'pmid': '29703576', 'type': 'DERIVED', 'citation': "Swanson JR, King WE, Sinkin RA, Lake DE, Carlo WA, Schelonka RL, Porcelli PJ, Navarrete CT, Bancalari E, Aschner JL, Perez JA, O'Shea TM, Walker MW. Neonatal Intensive Care Unit Length of Stay Reduction by Heart Rate Characteristics Monitoring. J Pediatr. 2018 Jul;198:162-167. doi: 10.1016/j.jpeds.2018.02.045. Epub 2018 Apr 24."}, {'pmid': '24412138', 'type': 'DERIVED', 'citation': 'Sullivan BA, Grice SM, Lake DE, Moorman JR, Fairchild KD. Infection and other clinical correlates of abnormal heart rate characteristics in preterm infants. J Pediatr. 2014 Apr;164(4):775-80. doi: 10.1016/j.jpeds.2013.11.038. Epub 2014 Jan 10.'}, {'pmid': '21864846', 'type': 'DERIVED', 'citation': "Moorman JR, Carlo WA, Kattwinkel J, Schelonka RL, Porcelli PJ, Navarrete CT, Bancalari E, Aschner JL, Whit Walker M, Perez JA, Palmer C, Stukenborg GJ, Lake DE, Michael O'Shea T. Mortality reduction by heart rate characteristic monitoring in very low birth weight neonates: a randomized trial. J Pediatr. 2011 Dec;159(6):900-6.e1. doi: 10.1016/j.jpeds.2011.06.044. Epub 2011 Aug 24."}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC) will require intubation and mechanical ventilation as a result of sepsis and sepsis-like illness.\n\nInfants will be randomly assigned to one of two groups. One group of infants will have the HRC index known to the physicians caring for them, and physicians will use the HRC index as they desire to aid in clinical management.\n\nInfants in the other group will have the HRC index recorded, but this information will not be displayed to the physicians caring for the infants.', 'detailedDescription': 'Following randomization, infants will be managed as usual practice. The treating physicians of the HRC-display group will be able to utilize the HRC score to assist in the care of the infant. The physicians of the no-display group will provide care as per standard.\n\nClinical symptoms will be treated according to the medical discretion of each physician. Cultures will be obtained and antibiotics administered as per the medical discretion of the physicians.\n\nClinical, culture results, antibiotic administration, ventilator use, and outcome at 120 days data will be collected on the infants as well as their HRC score calculated by the HeRO heart rate characteristics monitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants admitted to NICU\n* Birth weight \\< 1500 grams\n* Gestational age \\< or = 32 weeks\n* Informed consent obtained from parent\n\nExclusion Criteria:\n\n* Evidence of sustained cardiac arrhythmia\n* Use of an electronic pacemaker'}, 'identificationModule': {'nctId': 'NCT00307333', 'acronym': 'HeRO', 'briefTitle': 'Impact of Heart Rate Characteristics Monitoring in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Impact of Heart Rate Characteristics Monitoring in Neonates', 'orgStudyIdInfo': {'id': '10845'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.', 'interventionNames': ['Device: HeRO heart rate characteristics monitor']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.'}], 'interventions': [{'name': 'HeRO heart rate characteristics monitor', 'type': 'DEVICE', 'description': '24 hour continuous HRC monitoring with display', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '33101', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Winnie Plamer Hospital for Women and Babies', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '29617', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': "Vanderbilt Children's Hospital", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Joseph R Moorman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Medical Predictive Science Corporation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}