protocolSection identificationModule nctId: NCT06275932, orgStudyIdInfo id: TermoNeo/2023, briefTitle: Management of Healthy Newborn's Body Temperature at Birth, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: At birth, the newborn begins a process of adaptation to extrauterine life. One of the phases of this stabilization process is the maintenance of body temperature; indeed, the newborn passes from a warm environment (mother's womb) of around 37°C to an environment with a temperature lower (delivery room) and, therefore, must implement a series of physiological processes to be able to maintain body temperature constant and within ideal ranges through a balance between production and heat loss.Hypothermia at birth could cause risks or comorbidities such as an increased risk of infant mortality, hypoglycemia, sepsis, metabolic acidosis, respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH).One of the factors that affects heat loss in the delivery room is the relationship between surface area, volume and body mass of the newborn. The decrease in body temperature is directly related to gestational age and weight at birth; indeed, this problem is much more present in premature and/or low weight newborns at birth. Even if a full-term newborn has a more developed thermoregulation center than a preterm newborn, this does not mean that this type of newborns is not at risk heat dispersion.To date, the strategies that are implemented for the physiological newborn are documented in the literature are, in addition to the heat chain described by the World Health Organization (WHO), the implementation of skin-to-skin contact (skin to skin) mother-newborn.Some studies demonstrating the beneficial effect of this procedure on maintenance of the newborn's body temperature.The aim of this study is to evaluate two healthcare interventions to prevent heat loss of healthy newborns at birth., conditionsModule conditions: Newborn, Infant, conditions: Body Temperature, conditions: Delivery Room, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 776, type: ESTIMATED, armsInterventionsModule interventions name: Interventional group, interventions name: Standard of care group, outcomesModule primaryOutcomes measure: Newborn's body temperature at the end of skin-to-skin contact, secondaryOutcomes measure: Newborns' proportion with a body temperature < 36.5°C when arriving at the nursery, secondaryOutcomes measure: Newborns' proportion with temperature below 36.0°C at the end of skin-to-skin contact and at arrival in the nursery, secondaryOutcomes measure: Newborns' proportion with moderate hypothermia (temperature 36.0 - 36.4°C) at the end of skin-to-skin contact and at arrival in the nursery, secondaryOutcomes measure: Newborns' proportion with hyperthermia (temperature > 37.5°C) at the end of skin-to-skin contact and at arrival in the nursery, secondaryOutcomes measure: Newborns' average temperature one hour after arriving at the nursery, secondaryOutcomes measure: Duration of nursery stay, secondaryOutcomes measure: Duration of skin-to-skin contact, secondaryOutcomes measure: Newborns' proportion exclusively breastfed at discharge, secondaryOutcomes measure: Type of breastfeeding at discharge, secondaryOutcomes measure: Newborns' proportion with hypoglycemia during hospitalization, secondaryOutcomes measure: Newborns' proportion affected by respiratory distress syndrome, secondaryOutcomes measure: Newborns' proportion transferred to the Neonatal Intensive Care Unit (NICU), secondaryOutcomes measure: Newborns' weight loss at discharge, secondaryOutcomes measure: Mortality before discharge from hospital, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, city: Milan, zip: 20122, country: Italy, contacts name: Gabriele Sorrentino, pedRN, role: CONTACT, phone: +393496060149, email: gabriele.sorrentino@policlinico.mi.it, contacts name: Gabriele Sorrentino, pedRN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False