[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489107":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":42,"centralContacts":54,"locations":62,"responsibleParty":79,"collaborators":34,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":34,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":34,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":34,"overallStatus":64,"whyStopped":34,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Turku University Hospital","OTHER_GOV",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Term neonates","ACTIVE_COMPARATOR","Diagnostic Test: Brain ultrasound, brain contrast enhanced ultrasound, brain ultrasound elastography, cardiac ultrasound To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography Drug: Sulfur Hexafluoride To evaluate brain perfusion in infants with no suspected brain pathology using CEUS. Later, different patient groups could be compared to infants with no suspected brain pathology.\n\nOther Names:\n\n• SonoVue",[13,14],"Diagnostic Test: Brain contrast enhanced ultrasound, brain ultrasound elastography","Drug: Sulfur Hexafluoride",{"label":16,"type":17,"description":18,"interventionNames":19},"Neonatal asphyxia","EXPERIMENTAL","Diagnostic Test: Brain ultrasound, brain contrast enhanced ultrasound, brain ultrasound elastography To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography Drug: Sulfur Hexafluoride To evaluate brain perfusion in neonates after birth asphyxia\n\nOther Names:\n\n• SonoVue",[13,14],{"label":21,"type":17,"description":22,"interventionNames":23},"Neonatal stroke","Diagnostic Test: Brain contrast enhanced ultrasound, brain ultrasound elastography To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography Drug: Sulfur Hexafluoride To evaluate brain perfusion after neonatal stroke\n\nOther Names:\n\n• SonoVue",[13,14],{"label":25,"type":17,"description":26,"interventionNames":27},"Other neonatal brain pathologies","Diagnostic Test: Brain ultrasound, brain contrast enhanced ultrasound, brain ultrasound elastography To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography Drug: Sulfur Hexafluoride To evaluate brain perfusion in infants with other type (no asphyxia, stroke or preterm birth related) of brain pathology, like hydrocephalus, hemorrhage or central nervous system infection\n\nOther Names:\n\n• SonoVue",[13,14],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DIAGNOSTIC_TEST","Brain contrast enhanced ultrasound, brain ultrasound elastography","To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography",[16,21,25,9],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Sulfur Hexafluoride","To evaluate the differences in brain perfusion studied by CEUS, comparing different patient groups and babies with no suspected brain pathology",[16,21,25,9],[41],"SonoVue",[43,46,49,52],{"name":44,"affiliation":5,"role":45},"Tiina Laurikainen","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":5,"role":48},"Riitta Parkkola","STUDY_DIRECTOR",{"name":50,"affiliation":5,"role":51},"Vilhelmiina Parikka","STUDY_CHAIR",{"name":53,"affiliation":5,"role":51},"Jussi Hirvonen",[55,59],{"name":44,"role":56,"phone":57,"phoneExt":34,"email":58},"CONTACT","+35823135941","tiina.laurikainen@tyks.fi",{"name":47,"role":56,"phone":60,"phoneExt":34,"email":61},"+35823130148","riitta.parkkola@tyks.fi",[63],{"facility":5,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Turku","Southwestern Finland","20520","Finland","FI",{"type":71,"coordinates":72},"Point",[73,74],22.26869,60.45148,{"lat":74,"lon":73},[77],{"name":78,"role":56,"phone":34,"phoneExt":34,"email":34},"Tiina Laurikainen, MD",{"type":45,"investigatorFullName":44,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Principal Investigator","100489107","phase-3-neonatal-brain-ultrasound-with-ceus-and-elastography-100489107",false,"NCT05648812","Neonatal Brain Ultrasound With CEUS and Elastography","Contrast Enhanced Ultrasound and Elastography of the Neonatal Brain","Inclusion Criteria:\n\n* Babies less than 7 months treated at the neonatal units of Turku University hospital\n\nExclusion Criteria:\n\n* Pre-known genetic disease\n* Difficult congenital malformations that need surgical treatment\n* Central nervous system tumors\n* Weight less than 2,5 kg during examination\n* Medical history of SonoVue hypersensitivity\n* Uncontrolled systemic hypertension\n* Systolic pulmonary artery pressure \\> 90 mmHg\n* Unstable cardiovascular state","ALL","1 Minute","6 Months",{"count":92,"type":93},100,"ESTIMATED","INTERVENTIONAL",[96],"PHASE3","The aim of our study is to investigate changes of brain perfusion and elasticity in neonates during the time that a neonate is adapting to live outside the womb and during diseases that are suspected to affect neonatal brain perfusion. We use contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography to evaluate the state of brain perfusion. We will study neonates recruited from the Neonatal Units of Turku University Hospital.",[99,100,101],"Neonatal Hypoxic Ischemic Encephalopathy","Neonatal Stroke","Neonatal Encephalopathy, Unspecified","2026-01-13",{"date":104,"type":105},"2026-01-15","ACTUAL",{"date":107,"type":105},"2024-01-01",{"date":109,"type":93},"2029-12",{"name":5,"class":6},1]