Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02189759
Status:
COMPLETED
Last Update Posted:
2017-06-19
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Kangaroo Mother Care to Prevent Hypothermia in Term Infants
Sponsor:
Organization:
Raw JSON
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In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Kangaroo Mother Care to One Hour After Birth', 'description': "Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Continuous Kangaroo Mother Care to Discharge', 'description': "Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\\>38 degrees Celsius), the", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Standard Kangaroo Mother Care to Discharge', 'description': "Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. 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If infant bec"}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time of birth to 1 hour', 'description': 'Temperature taken per axilla using digital thermometer', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Kangaroo Mother Care to Discharge', 'description': "Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. 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'39', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 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'classes': [{'title': 'Zambia', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '368', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 375}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2014-07-11', 'resultsFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-04', 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Infants With Axillary Temperature <36.0 Degrees Celsius', 'timeFrame': 'Time of birth to 1 hour', 'description': 'Temperature taken per axilla using digital thermometer'}, {'measure': 'Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge', 'timeFrame': 'At discharge or 24 hours after birth (whichever is first)', 'description': 'Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth'}], 'secondaryOutcomes': [{'measure': 'Number Infants Admitted to the Neonatal Intensive Care Unit', 'timeFrame': 'Duration of hospitalization-an average of 2 weeks', 'description': 'Any admission to the neonatal intensive care unit for higher level care'}, {'measure': 'Duration of Kangaroo Mother Care', 'timeFrame': 'Duration of hospitalization-an average of 2 weeks', 'description': 'Skin to skin contact between baby and mother'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypothermia', 'Hyperthermia', 'Kangaroo Mother Care', 'Newborn'], 'conditions': ['Hypothermia', 'Newborn']}, 'referencesModule': {'references': [{'pmid': '29472198', 'type': 'DERIVED', 'citation': 'Ramani M, Choe EA, Major M, Newton R, Mwenechanya M, Travers CP, Chomba E, Ambalavanan N, Carlo WA. Kangaroo mother care for the prevention of neonatal hypothermia: a randomised controlled trial in term neonates. Arch Dis Child. 2018 May;103(5):492-497. doi: 10.1136/archdischild-2017-313744. Epub 2018 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\\<32.0 degrees C) in term infants (greater than or equal to 37 weeks of gestational age) when compared with routine WHO thermoregulation alone.', 'detailedDescription': 'The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding, postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\\<32.0 degrees C) in term infants (greater than or equal to weeks of gestational age) when compared with routine WHO thermoregulation alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Weeks', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Estimated gestational age greater than or equal to 37 weeks\n* Delivery in the hospital\n\nExclusion Criteria:\n\n* Abdominal wall defect or myelomeningocele\n* Major congenital anomalies\n* Blistering skin disorder'}, 'identificationModule': {'nctId': 'NCT02189759', 'briefTitle': 'Kangaroo Mother Care to Prevent Hypothermia in Term Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Randomized Trial of Kangaroo Mother Care to Prent Neonatal Hypothermia - Trials 2A & 2 B', 'orgStudyIdInfo': {'id': 'UAB Neo 012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Kangaroo Mother Care to one hour after birth', 'description': 'In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from birth to one hour after birth.', 'interventionNames': ['Other: Continuous Kangaroo Mother Care to one hour after birth']}, {'type': 'SHAM_COMPARATOR', 'label': 'Standard Kangaroo Mother Care to one hour after birth', 'description': 'Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from birth to 1 hour after birth.', 'interventionNames': ['Other: Standard Kangaroo Mother Care to one hour after birth']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Kangaroo Mother Care to discharge', 'description': 'In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from one hour after birth to discharge.', 'interventionNames': ['Other: Continuous Kangaroo Mother Care to discharge']}, {'type': 'SHAM_COMPARATOR', 'label': 'Standard Kangaroo Mother Care to discharge', 'description': 'Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from 1 hour after birth to discharge.', 'interventionNames': ['Other: Standard Kangaroo Mother Care to discharge']}], 'interventions': [{'name': 'Continuous Kangaroo Mother Care to one hour after birth', 'type': 'OTHER', 'description': "Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\\>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.", 'armGroupLabels': ['Continuous Kangaroo Mother Care to one hour after birth']}, {'name': 'Standard Kangaroo Mother Care to one hour after birth', 'type': 'OTHER', 'description': "Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\\>38 degrees Celsius), the infant will receive standard care which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.", 'armGroupLabels': ['Standard Kangaroo Mother Care to one hour after birth']}, {'name': 'Continuous Kangaroo Mother Care to discharge', 'type': 'OTHER', 'description': "Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\\>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.", 'armGroupLabels': ['Continuous Kangaroo Mother Care to discharge']}, {'name': 'Standard Kangaroo Mother Care to discharge', 'type': 'OTHER', 'description': "Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\\>38 degrees Celsius), standard treatment will be given which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.", 'armGroupLabels': ['Standard Kangaroo Mother Care to discharge']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lusaka', 'country': 'Zambia', 'facility': 'University Teaching Hospital', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Waldemar A Carlo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Manimaran Ramani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Manimaran Ramani, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}