[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559404":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":35,"responsibleParty":78,"collaborators":24,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":24,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":24,"maxAge":90,"enrollmentInfo":91,"targetDuration":24,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":57,"whyStopped":24,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Campania Luigi Vanvitelli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Unblinded CGM","EXPERIMENTAL","CGM data will be \"unblinded\", with alarms on for hypo and hyperglycemia. CGM data will be used to support clinical management including blood glucose measurements and decision making. Changes in glucose and insulin infusion will be based primarily on the real-time CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM data or before any treatment.",[13],"Device: Dexcom ONE+",{"label":15,"type":6,"description":16,"interventionNames":17},"Blinded CGM","CGM data will be blinded. Alarms for Hypo and hyperglycemia will be off. Glucose control will be monitored and managed according to standard clinical practice using intermittently sampled blood glucose concentrations.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Dexcom ONE+","In all the neonates recruited CGM sensor and transmitter will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for all the duration of therapeutic hypothermia.",[15,9],null,[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Paolo Montaldo, PhD","CONTACT","0815664023","+39","paolo.montaldo@unicampania.it",{"name":33,"role":28,"phone":24,"phoneExt":24,"email":34},"Simona Puzone, MD","simona.puzone@unicampania.it",[36,56,65],{"facility":37,"status":38,"city":39,"state":24,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"A.O.S.G. Moscati","NOT_YET_RECRUITING","Avellino","83100","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],14.79103,40.91494,{"lat":47,"lon":46},[50,53],{"name":51,"role":28,"phone":24,"phoneExt":24,"email":52},"Sabino Moschella, MD","sabino.moschella@aornmoscati.it",{"name":54,"role":28,"phone":24,"phoneExt":24,"email":55},"Mario Diplomatico, MD","mario.diplomatico@aornmoscati.it",{"facility":5,"status":57,"city":58,"state":24,"zip":59,"country":41,"countryCode":42,"cosmosGeoPoint":60,"geoPoint":64,"contacts":24},"RECRUITING","Naples","80100",{"type":44,"coordinates":61},[62,63],14.26811,40.85216,{"lat":63,"lon":62},{"facility":66,"status":38,"city":58,"state":24,"zip":67,"country":41,"countryCode":42,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Monaldi | | AORN - Ospedali dei ColliAORN - Ospedali dei Colli","80131",{"type":44,"coordinates":69},[62,63],{"lat":63,"lon":62},[72,75],{"name":73,"role":28,"phone":24,"phoneExt":24,"email":74},"Giovanni Chello, MD","giovanni.chello@ospedalideicolli.it",{"name":76,"role":28,"phone":24,"phoneExt":24,"email":77},"Massimiliano De Vivo, MD","massimiliano.devivo@ospedalideicolli.it",{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Paolo Montaldo","Principal Investigator","100559404","continuous-glucose-monitoring-in-hie-100559404",false,"NCT06563687","Continuous Glucose Monitoring in HIE","Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy: a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Birth weight \\>1.8kg\n* Gestation \\>35 weeks\n* Aged \\\u003C6hours\n* Moderate or severe HIE following perinatal asphyxia\n\nExclusion Criteria:\n\n* Major congenital malformations\n* Inborn errors of metabolism,\n* Congenital infections\n* Imminent death","ALL","6 Hours",{"count":92,"type":93},70,"ESTIMATED","INTERVENTIONAL",[96],"NA","The aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration. To further examine the efficacy of using CGM the following secondary outcomes in the two groups were assessed: mean glucose values, glucose variability within individuals, percentage of time that glucose values are in hyperglycaemic or hypoglycaemic ranges.\n\nRandomized controlled trial recruiting neonates (Birth weight \\>1.8kg, Gestation\\>36 weeks) with moderate or severe hypoxic ischemic encephalopathy (HIE) following perinatal asphyxia . Neonates will be randomly assigned (1:1) within 6 hours of birth to receive either the intervention with real-time CGM or standard care for 72 hours.",[99,100,101],"Hypoxic Ischemic Encephalopathy of Newborn","Hyperglycemia","Hypoglycemia",[103,104,105],"Continuous glucose monitoring","Neonatal hypoglycemia","Neonatal hyperglycemia","2024-08-20",{"date":108,"type":109},"2024-08-21","ACTUAL",{"date":111,"type":109},"2024-08-01",{"date":113,"type":93},"2026-12-01",{"name":5,"class":6},3]