[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563060":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":27,"locations":34,"responsibleParty":55,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":10,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University of Erlangen-Nürnberg Medical School","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neonates with perinatal asphyxia and indication for hypothermia treatment",null,"Included will be neonates with perinatal asphyxia that get an indication for hypothermia treatment (severe azidosis and signs of encephalopathy and under 6h of age and \\>36 gest. weeks). They will be monitored with CEUS\u002FULM at three different time points (T1: within first 6h of life\u002Fbefore hypothermia treatment, T2 = during hypothermia treatment\u002F6-78h of life, T3 = after hypothermia treatment\u002Fwithin first week of life.",[13],"Device: Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM","CEUS is a contrast based ultrasound technique and ULM (Ultrasound Localization Microscopy) is a post-processing bioinformatical method to quantify microvascular architecture and perfusion dynamics.",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Ferdinand Knieling, MD","FAU Erlangen-Nuernberg","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":23,"role":24},"Gregor Hanslik, MD",[28,32],{"name":22,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","0049 9131 85 33118","ferdinand.knieling@uk-erlangen.de",{"name":26,"role":29,"phone":30,"phoneExt":10,"email":33},"gregor.hanslik@uk-erlangen.de",[35],{"facility":23,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Erlangen","Bavaria","91054","Germany","DE",{"type":43,"coordinates":44},"Point",[45,46],11.00783,49.59099,{"lat":46,"lon":45},[49,50,51,52],{"name":22,"role":29,"phone":30,"phoneExt":10,"email":31},{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":26,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":53,"role":54,"phone":10,"phoneExt":10,"email":10},"Henriette Mandelbaum","SUB_INVESTIGATOR",{"type":24,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ferdinand Knieling","Principal Investigator, Pediatric Translational Imaging Laboratory","100563060","quantification-of-brain-and-kidney-perfusion-before-during-and-after-hypothermia-treatment-in-neonates-with-perinatal-asphyxia-using-contrast-enhanced-ultrasound-100563060",false,"NCT06611254","Quantification of Brain and Kidney Perfusion Before, During, and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound","Inclusion Criteria:\n\n* Fulfillment of the inclusion criteria for hypothermia treatment according to the AWMF guideline\n* Severe acidosis (pH ≤7.0 or a base deficit ≥16 mmol\u002Fl) in umbilical cord blood or a blood sample from the first hour of life, and\n* clinical signs of moderate or severe encephalopathy (severity grade 2 or 3 according to Sarnat \\& Sarnat), and\n* postnatal age ≤6h, and\n* gestational age ≥36 weeks' gestation\n* Consent of the parents\u002Flegal guardians\n* Time 1 (before the start of hypothermia treatment)\n\n  * Informing the parents\u002Flegal guardians present on site despite an emotionally stressful situation with high individual benefit for the patient\n  * If only one parent is present and able to provide information, their consent is sufficient - the second parent is informed repeatedly when they regain the ability to provide information\n  * Information adapted to the emergency situation, addressing the personal situation and comprehensible presentation of the plan\n* Time 2 (during hypothermia treatment)\n\n  --\\>Offer of a further informative discussion\u002Frepeated explanation with the parents\u002Flegal representatives before the second measurement in order to answer any questions that may have arisen\n* Suitable acoustic window\n* Availability of the qualified examiner\n\nExclusion Criteria:\n\n* Lack of consent of at least one parent\n* Pre-existing brain malformations\n* Absence of the competent examiner","ALL",{"count":66,"type":67},20,"ESTIMATED","OBSERVATIONAL","In this clinical study vascular dynamics in the neonatal brain and kidney will be monitored by CUES and ULM before, during and after hypothermia treatment in neonates with asphyxia.",[71,72,73],"Perinatal Asphyxia","Hypothermia Treatment","Gestational Age Min. 36SSW","2024-09-20",{"date":76,"type":77},"2024-09-24","ACTUAL",{"date":79,"type":77},"2024-06-24",{"date":81,"type":67},"2027-12-01",{"name":5,"class":6},1]