Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-03-15 @ 12:35 PM
Study NCT ID:
NCT03621956
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2018-08-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cardiac and Cerebral Hemodynamics With Umbilical Cord Milking Compared With Early Cord Clamping
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, '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': '858-939-4170', 'title': 'Anup Katheria, M.D.', 'organization': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The first 10 minutes of life.', 'eventGroups': [{'id': 'EG000', 'title': 'Umbilical Cord Milking', '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.\n\nUmbilical Cord Milking: 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.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Early Cord Clamping', 'description': 'The umbilical cord is clamped within 30 seconds of delivery.\n\nEarly Cord Clamping: The umbilical cord is clamped within 30 seconds of delivery.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'StO2 in the First 10 Minutes of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking', '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.'}, {'id': 'OG001', 'title': 'Early Cord Clamping', 'description': 'The umbilical cord is clamped within 30 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '7.15', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'birth to 10 minutes of life', 'description': 'Cerebral oxygenation derived from skeletal muscle oxygen saturation (StO2) measured by near-infrared spectroscopy (NIRS). Once the newborn is delivered, receives the intervention (UCM or ECC), and is stabilized during resuscitation, a NIRS sensor (Fore-Sight, CAS Medical, Branford, CT) will be placed on the right forehead within 10 minutes of the newborn being placed on the resuscitation bed.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate at 10 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Milking', '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.\n\nUmbilical Cord Milking: 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.'}, {'id': 'OG001', 'title': 'Early Cord Clamping', 'description': 'The umbilical cord is clamped within 30 seconds of delivery.\n\nEarly Cord Clamping: The umbilical cord is clamped within 30 seconds of delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '152', 'spread': '12.76', 'groupId': 'OG000'}, {'value': '160', 'spread': '12.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Heart rate was recorded from the electrocardiogram monitor.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Umbilical Cord Milking', '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.\n\nUmbilical Cord Milking: 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.'}, {'id': 'FG001', 'title': 'Early Cord Clamping', 'description': 'The umbilical cord is clamped within 30 seconds of delivery.\n\nEarly Cord Clamping: The umbilical cord is clamped within 30 seconds of delivery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Umbilical Cord Milking', '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.\n\nUmbilical Cord Milking: 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.'}, {'id': 'BG001', 'title': 'Early Cord Clamping', 'description': 'The umbilical cord is clamped within 30 seconds of delivery.\n\nEarly Cord Clamping: The umbilical cord is clamped within 30 seconds of delivery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.13', 'spread': '1.56', 'groupId': 'BG000'}, {'value': '38.95', 'spread': '1.72', 'groupId': 'BG001'}, {'value': '38.54', 'spread': '0.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Gestational Age in weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-11-16', 'size': 852127, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-02T15:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2018-08-06', 'resultsFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-02', 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'StO2 in the First 10 Minutes of Life', 'timeFrame': 'birth to 10 minutes of life', 'description': 'Cerebral oxygenation derived from skeletal muscle oxygen saturation (StO2) measured by near-infrared spectroscopy (NIRS). Once the newborn is delivered, receives the intervention (UCM or ECC), and is stabilized during resuscitation, a NIRS sensor (Fore-Sight, CAS Medical, Branford, CT) will be placed on the right forehead within 10 minutes of the newborn being placed on the resuscitation bed.'}], 'secondaryOutcomes': [{'measure': 'Heart Rate at 10 Minutes', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Heart rate was recorded from the electrocardiogram monitor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Near-Infrared Spectroscopy'], 'conditions': ['Birth Asphyxia With Neurologic Involvement']}, 'referencesModule': {'references': [{'pmid': '36827750', 'type': 'DERIVED', 'citation': 'Katheria AC, Law BHY, Poeltler D, Rich W, Ines F, Schmolzer GM, Lakshminrusimha S. Cardiac and cerebral hemodynamics with umbilical cord milking compared with early cord clamping: A randomized cluster crossover trial. Early Hum Dev. 2023 Mar;177-178:105728. doi: 10.1016/j.earlhumdev.2023.105728. Epub 2023 Feb 14.'}]}, 'descriptionModule': {'briefSummary': '3 clinical sites enrolling in the primary MINVI trial (NCT03631940) will collect Near Infrared Spectroscopy (NIRS) data in the first 10 minutes of life on a subset of 200 non-vigorous term and near-term infants enrolled in the trial.', 'detailedDescription': "Rationale: Caregivers and researchers raised theoretical concerns that the UCM technique may deliver blood rapidly toward a non-vigorous newborn predisposing them to higher rates of brain injury or dislodging cellular debris into the brain. However, of the 13 studies on term infants comparing UCM to ECC, none have reported adverse outcomes. Even in more fragile preterm infants, no harm has been reported. All demonstrated improvements similar to DCC with increased red cell mass (measured by hematocrit or hemoglobin) improved blood pressure, increased pulmonary blood flow and improved ferritin at 6 weeks to 6 months of age with UCM. Nevertheless, careful assessment of safety is essential. Immediate physiological measurements on a subset (n=200) of infants of the two sub-study sites where the use of NIRS is standard of care, University of Alberta and SMBHWN, to establish the safety and efficacy of UCM. This aim will further test our hypotheses that infants in the UCM group will have improved early cardiac and cerebral hemodynamics within the first 10 minutes.\n\nThe Near-infrared spectroscopy (NIRS) is a technology that allows non-invasive continuous real-time measurement of the regional tissue oxygen saturation (StO2) of organs such as the brain. There are well-established reference cerebral StO2 values for uncomplicated term and preterm deliveries; however, there are no completed RCTs using NIRS in the delivery room. Our group is currently leading the first multicenter trial (1R01HD088646-01A1) comparing DCC and UCM measuring NIRS at birth in premature infants. If cerebral oxygenation is improved, it will provide one plausible explanation for the long-term benefits expected with UCM. While published data exists on cerebral oxygenation directly comparing UCM with DCC, some studies demonstrated increases in cerebral oxygenation at 4 hours of age with DCC, and a decrease in cerebral oxygenation at birth with DCC compared to immediate cord clamping. To our knowledge, no studies using cerebral oxygenation in non-vigorous term/near-term infants have ever been performed. This sub-study (n=200) will yield the largest available sample of specific measurements of cerebral oximetry in non-vigorous term newborns.\n\nSubstudy Sites: Three sites experienced with NIRS (University of Alberta, Sharp Grossmont Hospital and SMBHWN) will obtain and report the physiological changes with UCM and ECC at 10 minutes of life. Data from the non-invasive monitoring devices are recorded using a continuous real-time data acquisition system that provides a second-by-second record of the resuscitation that is also time-linked to the video recordings. Both sites have 24/7 research team coverage that attend all high-risk deliveries. The research team will ensure accurate sensor placement and data collection. These two exceptional settings will allow us to collect significant data regarding resuscitation outcomes linked to cerebral oxygenation.\n\nProtocol for NIRS Sub-Study: At the two sub-study sites, the use of NIRS is standard of care.\n\nAs part of the NIRS sub-study, sites will collect physiological and resuscitation data from birth (mean airway pressure, fractional oxygen) in addition to cerebral oxygenation. Once the newborn is delivered, receives the intervention (UCM or ECC), and is stabilized during resuscitation, a NIRS sensor (Fore-Sight, CAS Medical, Branford, CT) will be placed on the right forehead within 10 minutes of the newborn being placed on the warmer. While arterial saturation and heart rate data will be available to the clinical team, data from NIRS will be blinded. Data on all study infants will be recorded for the first 10 minutes in the delivery room at the two sites. Heart rate, oxygen saturations, and cerebral oxygenation will be downloaded as per both site's practice for neonatal resuscitation."}, '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* Born at NIRS Sub-study site\n\nExclusion Criteria:\n\n* Known major congenital or chromosomal anomalies of newborn\n* Known cardiac defects other than small ASD, VSD and PDA\n* Complete placental abruption/cutting through the placenta at time of delivery\n* Monochorionic multiples\n* Cord Avulsion\n* Presence of non-reducible nuchal cord\n* Perinatal providers unaware of the protocol\n* Incomplete delivery data Infants born in extremis, for whom additional treatment will not be offered'}, 'identificationModule': {'nctId': 'NCT03621956', 'acronym': 'MINVINIRS', 'briefTitle': 'Cardiac and Cerebral Hemodynamics With Umbilical Cord Milking Compared With Early Cord Clamping', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'Cardiac and Cerebral Hemodynamics With Umbilical Cord Milking Compared With Early Cord Clamping: A Randomized Cluster Crossover Trial', 'orgStudyIdInfo': {'id': 'MINVI_NIRS Sub-study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Umbilical Cord Milking', '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.', 'interventionNames': ['Procedure: Umbilical Cord Milking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early Cord Clamping', 'description': 'The umbilical cord is clamped within 30 seconds of delivery.', '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 30 seconds of delivery.', 'armGroupLabels': ['Early Cord Clamping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91942', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Grossmont Hospial', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'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}}, {'zip': 'T6G 2R3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Governors of University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Anup Katheria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sharp Mary Birch Hospital for Women & Newborns'}]}, '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'}}}}