Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT04827394
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2021-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neonatal Warming to Prevent Hypothermia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'birju-shah@ouhsc.edu', 'phone': '405-271-5215', 'title': 'Birju Shah, MD', 'phoneExt': '42167', 'organization': 'University of Oklahoma Health Sciences Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Through discharge, assessed up to 3 months per participant', 'description': 'Adverse events were collected for participants throughout their participation in the study, up to their hospital or NICU discharge.', 'eventGroups': [{'id': 'EG000', 'title': 'Warming Mattress and Sterile Polyethylene Wrap Group-Mothers', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care Group-Mothers', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Warming Mattress and Sterile Polyethylene Wrap Group-Infants', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Standard of Care Group-Infants', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Elevated temperature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Temperature at Arrival to Warmer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'groupId': 'OG000', 'lowerLimit': '36.5', 'upperLimit': '37.3'}, {'value': '37.0', 'groupId': 'OG001', 'lowerLimit': '36.8', 'upperLimit': '37.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 minutes', 'description': 'Temperature at arrival to the Warmer', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Temperature at Exit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '36.4', 'upperLimit': '37.0'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '37.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 minutes', 'description': 'The temperature at exit is only available for n=21 in treatment groups and n=19 in control group.', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Temperature at NICU/Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '36.4', 'upperLimit': '36.8'}, {'value': '36.5', 'groupId': 'OG001', 'lowerLimit': '36.3', 'upperLimit': '36.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Temperature at admission to NICU/Recovery', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '10.0'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '11.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Highest bilirubin level of infant based on blood test', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Respiratory Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '114.3', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '189.9'}, {'value': '31.2', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '169.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Duration of respiratory support in the form of intubation or continuous positive airway pressure (if applicable)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Delayed Cord Clamp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '66.0'}, {'value': '62.0', 'groupId': 'OG001', 'lowerLimit': '33.0', 'upperLimit': '65.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 60 seconds after birth', 'description': 'Length of delayed cord clamp in seconds', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '20.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '14.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Length of hospital stay in days', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Age to Wean to Crib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Age to wean to crib in days', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypothermia at Warmer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately after cord clamping (up to 60 seconds after birth)', 'description': 'Number of infants with hypothermia at time of arrival to warmer', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypothermia at Completion of Resuscitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Hypothermia at the Completion of Resuscitation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypothermia at NICU/Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Hypothermia at NICU admission /Recovery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hyperthermia (>37.5C) at Warmer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Hyperthermia (\\>37.5C) at arrival to Warmer', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Hypoglycemia (less than 30mg/dL in the first 24 hours)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for NICU Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Whether or not infant was admitted to NICU', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Composite neonatal morbidity (if applicable)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Warming Mattress and Sterile Polyethylene Wrap Group', 'description': 'In the intervention group, the infant was placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'FG001', 'title': 'Standard of Care Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'The values reported reflect the total number of unique participants (mothers) assigned to each Arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.\n\nNeonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.\n\nSterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Due to the nature of the study, only females (mothers) were enrolled. The sex of the newborns was not collected.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'American Indian/Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/Not Reported', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Ethnicity Unknown or Not Reported', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Age', 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '28.7', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '30.3', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational age', 'classes': [{'categories': [{'measurements': [{'value': '241.0', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '242.1', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '241.6', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of prenatal visits', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '3.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'visits', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'groupId': 'BG000', 'lowerLimit': '30.2', 'upperLimit': '39.2'}, {'value': '32.5', 'groupId': 'BG001', 'lowerLimit': '27.9', 'upperLimit': '40.7'}, {'value': '33.35', 'groupId': 'BG002', 'lowerLimit': '27.9', 'upperLimit': '40.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Payor Status', 'classes': [{'title': 'Private', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Government/Self', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Recevied Prenatal Care', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Maternal Labor', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Rupture of Membranes', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Meconium Stain', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Maternal Complications', 'classes': [{'title': 'Chronic Hypertension', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Gestational Hypertension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Preeclampsia Without Severe Features', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Preeclampsia With Severe Features', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Eclampsia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'HELLP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Thyroid Disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'NICU Admission', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fetal Complications', 'classes': [{'title': 'Twins', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Fetal Growth Restriction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Oligohydramnios', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Polyhydramnios', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Sepsis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-18', 'size': 381874, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-05T10:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 using a block randomization scheme stratified by gestational age'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2021-03-04', 'resultsFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-30', 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temperature at Arrival to Warmer', 'timeFrame': '3 minutes', 'description': 'Temperature at arrival to the Warmer'}], 'secondaryOutcomes': [{'measure': 'Temperature at Exit', 'timeFrame': '3 minutes', 'description': 'The temperature at exit is only available for n=21 in treatment groups and n=19 in control group.'}, {'measure': 'Temperature at NICU/Recovery', 'timeFrame': '24 hours', 'description': 'Temperature at admission to NICU/Recovery'}, {'measure': 'Peak Bilirubin', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Highest bilirubin level of infant based on blood test'}, {'measure': 'Duration of Respiratory Support', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Duration of respiratory support in the form of intubation or continuous positive airway pressure (if applicable)'}, {'measure': 'Length of Delayed Cord Clamp', 'timeFrame': 'Up to 60 seconds after birth', 'description': 'Length of delayed cord clamp in seconds'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Length of hospital stay in days'}, {'measure': 'Age to Wean to Crib', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Age to wean to crib in days'}, {'measure': 'Hypothermia at Warmer', 'timeFrame': 'Immediately after cord clamping (up to 60 seconds after birth)', 'description': 'Number of infants with hypothermia at time of arrival to warmer'}, {'measure': 'Hypothermia at Completion of Resuscitation', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Hypothermia at the Completion of Resuscitation'}, {'measure': 'Hypothermia at NICU/Recovery', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Hypothermia at NICU admission /Recovery'}, {'measure': 'Hyperthermia (>37.5C) at Warmer', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Hyperthermia (\\>37.5C) at arrival to Warmer'}, {'measure': 'Hypoglycemia', 'timeFrame': '24 hours', 'description': 'Hypoglycemia (less than 30mg/dL in the first 24 hours)'}, {'measure': 'Need for NICU Admission', 'timeFrame': '24 hours', 'description': 'Whether or not infant was admitted to NICU'}, {'measure': 'Composite', 'timeFrame': 'Through hospital discharge up to 3 months', 'description': 'Composite neonatal morbidity (if applicable)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hypothermia']}, 'descriptionModule': {'briefSummary': 'Researchers are proposing a pilot randomized controlled trial evaluating the benefit of immediately warming preterm babies using a warming mattress and a plastic wrap, while delaying clamping the umbilical cord at the time of c-section in babies born between 32 and 36 weeks to determine if it reduces the risk of hypothermia.', 'detailedDescription': "The trial will be advertised and introduced to patients admitted to the OU Children's Hospital labor and delivery or antepartum units by research nurses. Interested participants will be consented. Researchers are choosing to only include patients undergoing non-emergent cesarean in order to improve their ability to control parameters such as room temperature and labor-related clinical or subclinical maternal infection, which are known confounders. Further, they are limiting their investigation to fetuses 32-36 weeks gestation, since this population represents the largest preterm delivery population. Recruitment and randomization will be stratified by gestational age with an aim to enroll at least 44 pregnancies at 32-34 weeks and 6 days and 20 pregnancies between 35-36 weeks and 6 days. Last, it is impossible to recruit patients outside of the inpatient setting for a study investigating preterm delivery, as such deliveries are rarely predictable in the outpatient setting. There will only be one site for this study, the OU Children's Hospital labor and delivery and antepartum units.\n\nThe proposed study is a pragmatic randomized controlled pilot trial of neonatal warming techniques with participants allocated in a 1:1 ratio using a random block allocation table using blocks of size 4 and 6 that are stratified by gestational age ranges of 35-36 weeks and 6 days and 32-34 weeks and 6 days. Since there cannot be a placebo intervention, neither the patient nor the neonatal team will be blinded to the group assignment. The group assignments will be made and coded by a third party at the time of randomization. Patients will be randomized to their respective groups immediately prior to surgery.\n\nThe surgical technician will be provided with the necessary neonatal wraps and mattresses in a sterile fashion, and they will ensure these are available on the surgical field once the cesarean has begun. In the intervention group, the thermal mattress will be activated immediately prior to hysterotomy and placed on the sterile field with delivery of the infant directly onto the mattress. The infant will be dried, stimulated and bulb suctioned as deemed necessary per standard of care followed by wrapping. In the non-intervention group, the infant will be delivered onto the sterile field, dried and suctioned as deemed necessary per OU standard. Cord clamping will be delayed for 60 seconds in all infants under the supervision of both the obstetrician and the neonatal resuscitation team. If either team believes delayed cord clamping is no longer considered safe, as is usual protocol, the cord will be clamped and cut and the baby will be handed off to the neonatology team. After the infant is handed to the neonatology team along with all group assignment specific materials (neonatal wrap and thermal mattress, if in the intervention group), neonatal temperature will be assessed immediately upon arrival to the resuscitation warmer using a digital thermometer placed in the axillary space. Infant temperature will be recorded at 1) arrival to the warmer, 2) after the neonatologist deems that in-room resuscitation is complete and 3) at admission to the Neonatal Intensive Care Unit (NICU), Mother Baby Unit (MBU) or Post-Anesthesia Care Unit (PACU) depending on the baby's needs; determined by the resuscitating physicians. These measurements will be recorded by research nurses in a data collection sheet. Further, the research nurse will record the time from delivery to the time it takes for the infant to arrive at the warmer. Upon arrival at the warmer, the mattress and wrap will be removed as neonatal evaluation takes place.\n\nAs immediate neonatal temperature is not generally discussed with patients unless there is an issue such as concern for infection, neonatal temperature will not be routinely discussed with all participants. Only if there is concern for neonatal infection or if there is hyperthermia (\\>37.5 degrees C) will the study results be discussed with the patient."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have non-emergent cesarean deliveries (defined as at least 2 hours prior to planned cesarean)\n* Gestational age between 32 weeks and 0 days and 36 weeks and 6 days determined per usual clinical parameters\n\nExclusion Criteria:\n\n* Fetal anomalies or death\n* Maternal diabetes\n* Neonates with blistering skin conditions\n* Reversed end diastolic umbilical artery flow\n* Placental abruption\n* Chorioamnionitis\n* Monochorionic multifetal pregnancies\n* Inability to provide consent\n* Provider perception that patient is in significant pain and provider perceived contraindications to delayed cord clamping.'}, 'identificationModule': {'nctId': 'NCT04827394', 'briefTitle': 'Neonatal Warming to Prevent Hypothermia', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Preventing Hypothermia in Moderate and Late Preterm Neonates - a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '12752'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'In the intervention group, the infant will be placed on the thermal mattress, then wrapped.', 'interventionNames': ['Device: Neonatal warming mattress', 'Device: Sterile polyethylene wrap']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.'}], 'interventions': [{'name': 'Neonatal warming mattress', 'type': 'DEVICE', 'description': 'Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.', 'armGroupLabels': ['Intervention group']}, {'name': 'Sterile polyethylene wrap', 'type': 'DEVICE', 'description': 'Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Birju Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma HSC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plans to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}