Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-01 @ 10:33 PM
Study NCT ID:
NCT03798093
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001238', 'term': 'Asphyxia Neonatorum'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000087526', 'term': 'Umbilical Cord Clamping'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Anup.Katheria@sharp.com', 'phone': '8589394170', 'title': 'Dr. Anup Katheria', 'organization': 'Sharp Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Assessed from neonate's birth to discharge home up to 180 days of life", 'description': 'Adverse events were assessed for all neonate participants enrolled in the study and were collected from delivery to discharge home or up to 180 days of life.\n\nAll known adverse events are reported in the All-Cause Mortality, serious adverse events, and other adverse events tables.', 'eventGroups': [{'id': 'EG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. Both participating hospitals were randomized to perform umbilical cord milking as the first intervention in the primary trial.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 0, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery. Both participating hospitals were randomized to perform early cord clamping as the second intervention in the primary trial.', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 0, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Left Ventricular Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. Both participating hospitals were randomized to perform umbilical cord milking as the first intervention in the primary trial.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery. Both participating hospitals were randomized to perform early cord clamping as the second intervention in the primary trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '225', 'spread': '64', 'groupId': 'OG000'}, {'value': '187', 'spread': '52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'least squares', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.112', 'ciLowerLimit': '-29.3', 'ciUpperLimit': '1.7', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 ± 6 hours of life', 'description': 'Left ventricular output measurements taken by cardiac ultrasound.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Right Ventricular Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '284', 'spread': '88', 'groupId': 'OG000'}, {'value': '222', 'spread': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 ± 6 hours of life', 'description': 'Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Superior Vena Cava Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'spread': '36', 'groupId': 'OG000'}, {'value': '86', 'spread': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 ± 6 hours of life', 'description': 'superior vena cava (SVC) flow (Diameter obtained from the infraclavicular view (hybrid view) and doppler assessment from the subcostal view of the neonatal echocardiogram exam performed at 12 hours of life ± 6 hours.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Peak Systolic Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17', 'spread': '3', 'groupId': 'OG000'}, {'value': '-22', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 ± 6 hours of life', 'description': 'This measurement reflects the deformation (strain) of the heart muscle during systole (the phase of the heartbeat when the heart contracts) relative to its original length. More negative values indicate better myocardial function while values closer to 0 suggest impaired myocardial function.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Peak Systolic Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '.06', 'spread': '.02', 'groupId': 'OG000'}, {'value': '.07', 'spread': '.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 ± 6 hours of life', 'description': 'Measure of left and right ventricular peak systolic tissue doppler velocity on neonatal echocardiogram performed at 12 hours of life ± 6 hours.', 'unitOfMeasure': 'meters/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tricuspid Annular Plane Systolic Excursion Measurement in Neonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.04', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '9.65', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 ± 6 hours of life', 'description': 'Assessment of tricuspid annular plane systolic excursion in the neonate by echocardiogram performed at 12 hours of life ± 6 hours', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Neonates With a Patent Ductus Arteriosus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 ± 6 hours of life', 'description': 'Diagnosis of patent ductus arteriosus in neonate by echocardiogram with diameter measurement and direction of flow.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neonatal Direction of Ductal Shunt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'title': 'All left to right', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'All right to left', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bidirectional', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 ± 6 hours of life', 'description': 'Direction of ductal shunt in neonate assessed by echocardiogram which was performed at 12 hours of life ± 6 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Direction of shunt assessed only for neonates with a patent ductus arteriosus present.'}, {'type': 'POST_HOC', 'title': 'Diameter of Neonatal Ductus Arteriosus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 ± 6 hours of life', 'description': 'Diameter of neonatal ductus arteriosus assessed by echocardiogram which was performed at 12 hours of life ± 6 hours', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Neonatal Peak Pulmonary Artery Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '15', 'groupId': 'OG000'}, {'value': '27', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 ± 6 hours of life', 'description': 'Neonatal peak pulmonary artery pressure as measured by echocardiogram at 12 hours of life ± 6 hours.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Mean Neonatal Blood Pressure at Time of Echocardiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '7', 'groupId': 'OG000'}, {'value': '46', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 ± 6 hours of life', 'description': 'blood pressure measurement obtained at the time of cardiac ultrasound examination', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Median Neonatal Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.'}, {'id': 'OG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 to 48 hours of life', 'description': 'Single neonatal hemoglobin measurement obtained between 12 and 48 hours of life either as part of standard care or obtained with parental written consent', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Umbilical Cord Milking Then Early Cord Clamping Site Randomization - Neonate', 'description': 'In the first study period infants assessed as non-vigorous at delivery had the umbilical cord is grasped by the obstetric provider, and blood was pushed toward the infant 4 times before the cord is clamped.\n\nIn the second study period infants assessed as non-vigorous at delivery had the umbilical cord clamped by 60 seconds of life.'}, {'id': 'FG001', 'title': 'Early Cord Clamping Then Umbilical Cord Milking - Neonate', 'description': 'In the first study period infants assessed as non-vigorous at delivery had the umbilical cord clamped as soon as possible and within 60 seconds of delivery. In the second study period umbilical cord was grasped by the obstetric provider, and blood was pushed toward the infant 4 times before the cord is clamped.'}], 'periods': [{'title': 'Initial Randomized Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '106'}, {'comment': 'None of the hospital sites randomized to perform early cord clamping then umbilical cord milking recruited participants for this substudy.', 'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '106'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Crossover Randomized Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': "In this study design the participants recruited in the initial study period with treatment of umbilical cord milking did not continue on to the crossover period. In the cross over period hospital sites recruited new participants with a target enrollment equivalent to the site's recruitment in the initial study period and performed early cord clamping in the second study period.", 'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '121'}, {'comment': 'None of the hospital sites randomized to perform early cord clamping then umbilical cord milking recruited participants for this substudy.', 'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '121'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Hospital', 'recruitmentDetails': 'Recruitment took place at two maternity hospitals involved in a cluster crossover randomization trial of non-vigorous infants at birth randomized to perform umbilical cord milking in the initial period (January 2019-January 2020) and early cord clamping in the crossover period (February 2020- March 2021). Participants were enrolled in this study upon parental consent for a neonatal echocardiogram in the first 12 hours of life. Participants enrolled in periods 1 \\& 2 are unique participants.', 'preAssignmentDetails': 'The two hospitals who participated in the echocardiography sub-study and were both randomized to implement umbilical cord milking in the initial period (Period 1) and randomized to implement early cord clamping in the cross over period (Period 2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Umbilical Cord Milking - Neonate', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. Both participating hospitals were randomized to perform umbilical cord milking as the first intervention in the primary trial. Maternal data is presented for all participating mothers. Only unique participants are presented.'}, {'id': 'BG001', 'title': 'Early Cord Clamping - Neonate', 'description': 'The umbilical cord is clamped as early as possible and within 60 seconds of delivery. Both participating hospitals were randomized to perform early cord clamping as the second intervention in the primary trial. Maternal data is presented for all participating mothers. Only unique participants are presented.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Neonatal Birth Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '40'}, {'value': '39', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '40'}, {'value': '39', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Maternal Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '33'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '36'}, {'value': '31', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Neonatal Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Neonatal Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Maternal Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Neonatal Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Maternal Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of neonates delivered by a mother with diabetes during pregnancy.', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Hypertension or Pre-eclampsia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of neonates delivered by a mother who experienced hypertension or pre-eclampsia during pregnancy.', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Intrauterine Inflammation/Infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of neonates delivered by a mother diagnosed with intrauterine inflammation or intrauterine infection.', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Group B Streptococcus Positive', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number on infants born to a mother with positive group B streptococcus culture prior to delivery', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal General Anesthesia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of neonates delivered by a mother who was administered general anesthesia at the time of delivery.', 'unitOfMeasure': 'Participants'}, {'title': 'Multiple Gestation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of neonates delivered by a mother with a multiple gestation pregnancy', 'unitOfMeasure': 'Participants'}, {'title': 'Delivery of the Neonate via Cesarean Section', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of hours Membranes were Ruptured Before Delivery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '17'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '6', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hours', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Neonatal Weight at Birth', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3443', 'spread': '543', 'groupId': 'BG000'}, {'value': '3386', 'spread': '584', 'groupId': 'BG001'}, {'value': '3413', 'spread': '564', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Neonates with Poor Color at Birth', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "In the first 15 seconds of life the infant's skin color was assessed by the obstetric provider and assessment of poor color (pale, dusky, cyanotic) was reported on the study specific case report form.", 'unitOfMeasure': 'Participants'}, {'title': 'Neonates with Poor Tone at Birth', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "In the first 15 seconds of life the infant's tone was assessed by the obstetric provider and assessment of poor infant tone was reported on the study specific case report form.", 'unitOfMeasure': 'Participants'}, {'title': 'Neonates with Poor Respiratory Effort at Birth', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'In the first 15 seconds of life the infant is assessed for respiratory effort by the obstetric provider and assessment of poor respiratory effort it reported on the study specific case report form.', 'unitOfMeasure': 'Participants'}, {'title': 'Neonates Treated with Therapeutic Hypothermia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of neonates treated with therapeutic hypothermia (cooling to 33.5 degrees Celsius) for 72 hours and initiated in the first 6 hours of life.', 'unitOfMeasure': 'Participants'}, {'title': 'Neonates Treated with Cardiac Inotropes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Neonates Treated with Volume Expanders', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Time of Echocardiogram Exam from Neonate's Time of Birth", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '17'}, {'value': '15', 'groupId': 'BG001', 'lowerLimit': '11', 'upperLimit': '17'}, {'value': '15', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hours', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Venous Cord Blood Gas pH', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.266', 'spread': '.095', 'groupId': 'BG000'}, {'value': '7.234', 'spread': '.122', 'groupId': 'BG001'}, {'value': '7.249', 'spread': '.111', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'no units', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Venous cord gas values reported for all neonates with results available for venous cord blood pH results.'}, {'title': 'Venous Cord Blood Gas Base Excess', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-6.60', 'spread': '3.12', 'groupId': 'BG000'}, {'value': '-7.31', 'spread': '4.22', 'groupId': 'BG001'}, {'value': '-6.98', 'spread': '3.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Venous cord gas values reported for all neonates with results available for venous cord blood base excess results.'}, {'title': 'Arterial Cord Blood Gas pH', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.173', 'spread': '.104', 'groupId': 'BG000'}, {'value': '7.125', 'spread': '.140', 'groupId': 'BG001'}, {'value': '7.148', 'spread': '.127', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'no units', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Arterial cord gas values reported for all neonates with results available arterial cord blood pH results.'}, {'title': 'Arterial Cord Blood Gas Base Excess', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-8.74', 'spread': '3.96', 'groupId': 'BG000'}, {'value': '-9.77', 'spread': '5.11', 'groupId': 'BG001'}, {'value': '-9.29', 'spread': '4.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Venous cord gas values reported for all neonates with results available for arterial cord blood base excess results.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-16', 'size': 1139757, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-06T14:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Cardiac research sonographers that obtained study measurements were blinded to the study intervention'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Cluster Randomized Crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2019-01-07', 'resultsFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-05', 'studyFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tricuspid Annular Plane Systolic Excursion Measurement in Neonate', 'timeFrame': '12 ± 6 hours of life', 'description': 'Assessment of tricuspid annular plane systolic excursion in the neonate by echocardiogram performed at 12 hours of life ± 6 hours'}, {'measure': 'Number of Neonates With a Patent Ductus Arteriosus', 'timeFrame': '12 ± 6 hours of life', 'description': 'Diagnosis of patent ductus arteriosus in neonate by echocardiogram with diameter measurement and direction of flow.'}, {'measure': 'Neonatal Direction of Ductal Shunt', 'timeFrame': '12 ± 6 hours of life', 'description': 'Direction of ductal shunt in neonate assessed by echocardiogram which was performed at 12 hours of life ± 6 hours.'}], 'primaryOutcomes': [{'measure': 'Left Ventricular Output', 'timeFrame': '12 ± 6 hours of life', 'description': 'Left ventricular output measurements taken by cardiac ultrasound.'}], 'secondaryOutcomes': [{'measure': 'Neonatal Right Ventricular Output', 'timeFrame': '12 ± 6 hours of life', 'description': 'Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours.'}, {'measure': 'Neonatal Superior Vena Cava Flow', 'timeFrame': '12 ± 6 hours of life', 'description': 'superior vena cava (SVC) flow (Diameter obtained from the infraclavicular view (hybrid view) and doppler assessment from the subcostal view of the neonatal echocardiogram exam performed at 12 hours of life ± 6 hours.'}, {'measure': 'Neonatal Peak Systolic Strain', 'timeFrame': '12 ± 6 hours of life', 'description': 'This measurement reflects the deformation (strain) of the heart muscle during systole (the phase of the heartbeat when the heart contracts) relative to its original length. More negative values indicate better myocardial function while values closer to 0 suggest impaired myocardial function.'}, {'measure': 'Neonatal Peak Systolic Velocity', 'timeFrame': '12 ± 6 hours of life', 'description': 'Measure of left and right ventricular peak systolic tissue doppler velocity on neonatal echocardiogram performed at 12 hours of life ± 6 hours.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Umbilical Cord Milking', 'Immediate Cord Clamping', 'Resuscitation'], 'conditions': ['Birth Asphyxia']}, 'referencesModule': {'references': [{'pmid': '36914049', 'type': 'DERIVED', 'citation': 'Katheria A, Mercer J, Poeltler D, Morales A, Torres N, Lakshminrusimha S, Singh Y. Hemodynamic Changes with Umbilical Cord Milking in Nonvigorous Newborns: A Randomized Cluster Cross-over Trial. J Pediatr. 2023 Jun;257:113383. doi: 10.1016/j.jpeds.2023.03.001. Epub 2023 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents.', 'detailedDescription': 'Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents. The consent will have a check box to indicate if they consent to the additional test.\n\nEchocardiographic measurements will be performed on all infants at 12 hours +/- 6 hours of age by our research sonographers who are blinded to infant randomization. Measurements will be taken according to a standard operating procedure to assess systemic blood flow, by superior vena cava (SVC) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular output (LVO) (ml/kg/min), measures of left and right ventricular tissue Doppler and strain imaging. These measurements will be performed offline at a later time. Data will be entered into REDCap.\n\nIf any structural abnormalities are found, the attending pediatrician will be notified of the abnormal echocardiogram. The consent will clearly state that this echo is not for diagnostic purposes. Any additional studies including an official complete echocardiogram and or cardiology consultation will be left to the discretion of the attending pediatrician, as he/she deems necessary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '35 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Non-vigorous newborns born between 35-42 weeks gestation.\n\nExclusion Criteria:\n\n* Known major congenital or chromosomal anomalies of newborn.\n* Known cardiac defects other than small atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (PDA).\n* Complete placental abruption/cutting through the placenta at time of delivery.\n* Monochorionic multiples\n* Cord anomaly (i.e. cord avulsion or true knot)\n* Presence of non-reducible nuchal cord\n* Perinatal providers unaware of the protocol\n* Incomplete delivery data\n* Infants born in extremis, for whom additional treatment will not be offered.'}, 'identificationModule': {'nctId': 'NCT03798093', 'briefTitle': 'Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI)', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'Hemodynamic Changes With Umbilical Cord Milking in Nonvigorous Newborns', 'orgStudyIdInfo': {'id': 'MINVI Echo Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Umbilical Cord Milking', 'description': "The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for Early Cord Clamping as we have demonstrated in our previous trials.", 'interventionNames': ['Procedure: Umbilical Cord Milking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early Cord Clamping', 'description': 'This will occur by clamping the umbilical cord as soon as possible. Since both Early Cord Clamping and Umbilical Cord Milking will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.', 'interventionNames': ['Procedure: Early Cord Clamping']}], 'interventions': [{'name': 'Umbilical Cord Milking', 'type': 'PROCEDURE', 'description': 'At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.', 'armGroupLabels': ['Umbilical Cord Milking']}, {'name': 'Early Cord Clamping', 'type': 'PROCEDURE', 'description': 'The umbilical cord is clamped within 60 seconds of delivery.', 'armGroupLabels': ['Early Cord Clamping']}]}, '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 Mary Birch Hospital for Women & Newborns'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharp HealthCare', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sharp Mary Birch Hospital for Women & Newborns', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Neonatal Research Institute', 'investigatorFullName': 'Anup Katheria, M.D.', 'investigatorAffiliation': 'Sharp HealthCare'}}}}