protocolSection identificationModule nctId: NCT06277869, orgStudyIdInfo id: PR-22146, briefTitle: Effectiveness Trial of Thermal Jacket, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-22, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: International Centre for Diarrhoeal Disease Research, Bangladesh, class: OTHER, collaborators name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, collaborators name: Directorate General of Health Services (DGHS), Bangladesh, collaborators name: Poeticgem International Ltd, descriptionModule briefSummary: Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.Maintaining continuous Kangaroo Mother Care (KMC) for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or low birthweight (LBW) neonates warm during transportation.The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings.Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh.Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh., conditionsModule conditions: Preterm Neonate, conditions: Low Birthweight Neonate, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Stepped wedge cluster randomised trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Thermal Jacket, interventions name: Kangaroo Mother Care, outcomesModule primaryOutcomes measure: Body temperature of preterm or low birthweight neonates maintain the euthermic range., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lakshmipur District Hospital, status: RECRUITING, city: Lakshmipur, state: Chattogram, zip: 3700, country: Bangladesh, contacts name: Ahmed Kabir, MBBS, role: CONTACT, phone: 01842587456, email: laxmipur@hospital.dghs.gov.bd, geoPoint lat: 22.9443, lon: 90.83005, locations facility: Kushtia 250 Bedded General Hospital, status: RECRUITING, city: Kushtia, state: Khulna, zip: 7000, country: Bangladesh, contacts name: Md. Rafiqul Islam, MBBS, role: CONTACT, phone: 01829699289, email: kushtia@hospi.dghs.gov.bd, geoPoint lat: 23.9028, lon: 89.11943, locations facility: Jamalpur 250 Beded General Hospital, status: NOT_YET_RECRUITING, city: Jamalpur, state: Mymensingh, zip: 2000, country: Bangladesh, contacts name: Muhammad Mahfuzur Rahman, MBBS, role: CONTACT, phone: 01716267689, email: jamalpur@hospital.dghs.gov.bd, geoPoint lat: 24.91965, lon: 89.94812, hasResults: False