Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-30 @ 8:25 PM
Study NCT ID:
NCT04364204
Status:
UNKNOWN
Last Update Posted:
2021-10-05
First Post:
2020-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypothermia Prevention in Low Birthweight and Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D060127', 'term': 'Kangaroo-Mother Care Method'}], 'ancestors': [{'id': 'D056888', 'term': 'Patient Positioning'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007224', 'term': 'Infant Care'}, {'id': 'D002654', 'term': 'Child Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypothermia', 'timeFrame': 'up to 28 days', 'description': 'Axilliary temperature \\<36.5 degrees Celsius assessed at 7 days'}], 'secondaryOutcomes': [{'measure': 'Weight gain', 'timeFrame': '7 days and 28 days', 'description': 'Change in weight in grams assessed at 7 days and 28 days'}, {'measure': 'Kangaroo Mother Care', 'timeFrame': '7 days and 28 days', 'description': 'Proportion of babies who received KMC for at least 8 hours in the last 24 hours assessed at 7 days and 28 days'}, {'measure': 'All cause mortality', 'timeFrame': '28 days', 'description': 'Number of neonatal deaths'}, {'measure': 'Exclusive breastfeeding', 'timeFrame': '7 days and 28 days', 'description': 'Proportion of babies who were exclusively breastfed in the last 24 hours assessed at 7 days and 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['newborn', 'low birthweight', 'kangaroo mother care'], 'conditions': ['Neonatal Hypothermia']}, 'descriptionModule': {'briefSummary': 'Preterm birth complications are the leading cause of neonatal mortality and account for over one million neonatal deaths annually. About 12% of babies are born before 37 weeks of gestation, and are at risk for hypothermia, hypoglycemia, infections, and mortality during the first 28 days of life. Kangaroo Mother Care (KMC) has been shown to reduce hypothermia, neonatal infections and neonatal mortality, while improving weight gain and mother-infant attachment; however, implementation to scale has been slow. The BEMPU® bracelet offers the opportunity to monitor the body temperature of newborns for the early detection of hypothermia and to increase the uptake of KMC. Further research is needed to evaluate the impact of the BEMPU® bracelet on KMC practices and neonatal health outcomes and facilitate its adoption in low-resource settings. The goal of this research is to evaluate its effect on KMC practices and neonatal health outcomes in Ghana. Evidence of a significant impact on outcomes will provide critical evidence to facilitate prompt identification of hypothermia, maximize the benefits of KMC, decrease the risk of neonatal death, and impact the leading cause of neonatal mortality in Ghana and other settings.', 'detailedDescription': "This study will evaluate the effect of the bracelet on KMC practices and neonatal health outcomes in LBW infants using a randomized controlled trial. Infants currently being treated in the KMC or neonatal wards of the participating hospitals will be screened for eligibility by study nurses. After obtaining parental consent, infants will be randomly assigned with a 1:1 ratio to KMC with and without the BEMPU® bracelet.\n\nA standardized questionnaire will be administered to each mother to collect information on socio-demographic characteristics and contact information. As is the standard of care, all mothers regardless of study arm will be taught how to provide KMC, how to monitor the infant's condition and recognize dangerous clinical signs during KMC and will be supported by a nurse during initial attempts at practicing KMC.\n\nMothers of infants randomly allocated to the intervention arm will be taught to use the bracelet. The meaning of the audiovisual alarm will be explained as well as the measures to be taken if the device indicates any sign of hypothermia. There will not be any additional training beyond that pertaining to the BEMPU® bracelet. The study nurse will then place the BEMPU® bracelet on the wrist of the infant. Infants in the intervention arm will wear the bracelet for up to 28 days post-discharge.\n\nAfter discharge, participants in both the intervention and control arms will receive two study visits; one at 7 days post discharge and one at 28 days post-discharge. During each visit, infants will receive a physical examination to collect weight, length, head circumference and axillary temperature, and additional data will be collected on history of illnesses, care-seeking and treatment, KMC and feeding practices, and frequency of use of the bracelet (if applicable)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently being treated in the KMC or neonatal ward at one of the participating hospitals\n* Age\\<28 days\n* Weight \\<2,500 grams at birth\n* Clinically stable\n* Mother is available, willing and able to provide consent\n\nExclusion Criteria:\n\n* Clinically unstable\n* Twin or multiple birth\n* Ineligible to initiate KMC\n* Mother \\<18 years of age\n* Residence outside health facility catchment area or intention to relocate during the four weeks following discharge'}, 'identificationModule': {'nctId': 'NCT04364204', 'briefTitle': 'Hypothermia Prevention in Low Birthweight and Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Hypothermia Prevention in Low Birthweight and Preterm Infants', 'orgStudyIdInfo': {'id': 'Pro00095600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kangaroo mother care with bracelet', 'interventionNames': ['Other: Kangaroo Mother Care and BEMPU bracelet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Kangaroo mother care', 'interventionNames': ['Other: Kangaroo Mother Care']}], 'interventions': [{'name': 'Kangaroo Mother Care and BEMPU bracelet', 'type': 'OTHER', 'description': 'Kangaroo mother care involves early, continuous and prolonged skin-to-skin contact between a mother and her newborn, frequent and exclusive breastfeeding and early discharge from hospital. The BEMPU bracelet, also known as the BEMPU Tempwatch, is a silicone band with a thermistor metal cup that emits an audio alarm and flashes an orange light when the body temperature drops below 36.5⁰C, signaling hypothermia and prompting caregiver to provide thermal care.', 'armGroupLabels': ['Kangaroo mother care with bracelet']}, {'name': 'Kangaroo Mother Care', 'type': 'OTHER', 'description': 'Kangaroo mother care involves early, continuous and prolonged skin-to-skin contact between a mother and her newborn, frequent and exclusive breastfeeding and early discharge from hospital. This is the current standard of care for low birthweight/preterm infants.', 'armGroupLabels': ['Kangaroo mother care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Accra', 'country': 'Ghana', 'contacts': [{'name': 'Prince Owusu', 'role': 'CONTACT'}], 'facility': 'Achimota General Hospital', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}, {'city': 'Accra', 'country': 'Ghana', 'contacts': [{'name': 'Prince Owusu', 'role': 'CONTACT'}], 'facility': 'Greater Accra Regional Hospital', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}, {'city': 'Accra', 'country': 'Ghana', 'contacts': [{'name': 'Prince Owusu', 'role': 'CONTACT'}], 'facility': 'Korle-Bu Teaching Hospital', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}, {'city': 'Accra', 'country': 'Ghana', 'contacts': [{'name': 'Prince Owusu', 'role': 'CONTACT'}], 'facility': "Princess Marie Luis Children's Hospital", 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}, {'city': 'Cape Coast', 'country': 'Ghana', 'contacts': [{'name': 'Prince Owusu', 'role': 'CONTACT'}], 'facility': 'Central Regional Hospital', 'geoPoint': {'lat': 5.10535, 'lon': -1.2466}}, {'city': 'Koforidua', 'country': 'Ghana', 'contacts': [{'name': 'Prince Owusu', 'role': 'CONTACT'}], 'facility': 'Eastern Regional Hospital', 'geoPoint': {'lat': 6.09408, 'lon': -0.25913}}], 'centralContacts': [{'name': 'Mufaro Kanyangarara', 'role': 'CONTACT', 'email': 'mufaro@mailbox.sc.edu', 'phone': '8037777562'}], 'overallOfficials': [{'name': 'Mufaro Kanyangarara', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}, {'name': 'Prince Owusu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Learning and Childhood Development - Ghana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre for Learning and Childhood Development - Ghana', 'class': 'UNKNOWN'}, {'name': 'Ghana Health Services', 'class': 'OTHER_GOV'}, {'name': 'Korle-Bu Teaching Hospital, Accra, Ghana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mufaro Kanyangarara', 'investigatorAffiliation': 'University of South Carolina'}}}}