[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565751":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":45,"locations":55,"responsibleParty":90,"collaborators":92,"id":94,"slug":10,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":10,"studyType":108,"phases":10,"briefSummary":109,"conditions":110,"keywords":118,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"St. Olavs Hospital","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Feasibility study - Healthy neonates",null,"Neonates born with gestational week \\\u003C 32 weeks, gestational week 32-37 and at term. Will will include 20-30 of each sex in each group.",[13],"Device: NeoDoppler - CE certified",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients with patent ductus arteriosus (premature infants)","Preterm neonates with patent ductus arteriosus (n=20)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Different groups of sick neonates","Neonates with different medical conditions such as perinatal asphyxia, stroke, pulmonary hypertension and congenital heart disease will be conducted. We will include 5-30 neonates in each group.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Neonates\u002Finfants undergoing procedures","Neonates\u002Finfants undergoing procedures such as intubation, anesthesia, spinal puncture, peripheral and central arterial and venous catheter. We will include 20-30 neonates.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Neonates with infection\u002Fsepsis","Infants with infection\u002Fsepsis and\u002For meningitis (n=40).",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"DEVICE","NeoDoppler - CE certified","The NeoDoppler is small and light weighed constructed as a single element transducer, that can be gently fixed over the fontanelle. The system is fully compatible for cooccurring use with other intensive care equipment for neonates as well as caregiving from the parents. It is capable of measuring cerebral blood flow at different depths of the brain simultaneously. The Doppler velocity measurements arise from a cylindrical volume of tissue. It is therefore less sensitive to the exact position and angle of the probe over the fontanel to target the vessels of interest than standard hand-held Doppler. This means that the NeoDoppler system may be placed by healthcare professionals who do not have specialized training performing diagnostic ultrasound exams of the cerebral vasculature in neonates.",[19,9,27,23,15],[37,41],{"name":38,"affiliation":39,"role":40},"Siri Ann Nyrnes, MD, PhD","Childrens Clinic, St. Olavs University Hospital and NTNU","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":44},"Øyvind Rognmo, PhD","Norwegian University of Science and Technology","STUDY_DIRECTOR",[46,50],{"name":38,"role":47,"phone":48,"phoneExt":10,"email":49},"CONTACT","004793062121","siri.a.nyrnes@ntnu.no",{"name":51,"role":47,"phone":52,"phoneExt":53,"email":54},"Siv Steinsmo Ødegård, MD, PhD","97772989","0047","siv.steinsmo@gmail.com",[56],{"facility":57,"status":58,"city":59,"state":10,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Children's clinic, St. Olavs University Hospital","RECRUITING","Trondheim","7030","Norway","NO",{"type":64,"coordinates":65},"Point",[66,67],10.39506,63.43049,{"lat":67,"lon":66},[70,73,77,78,81,82,84,86,88],{"name":38,"role":47,"phone":71,"phoneExt":10,"email":72},"+4793062121","siri.ann.nyrnes@stolav.no",{"name":74,"role":47,"phone":75,"phoneExt":10,"email":76},"Ragnhild Støen, MD, PhD","+4799565665","Ragnhild.Stoen@stolav.no",{"name":38,"role":40,"phone":10,"phoneExt":10,"email":10},{"name":79,"role":80,"phone":10,"phoneExt":10,"email":10},"Hester Berger, MD, PhD","SUB_INVESTIGATOR",{"name":74,"role":80,"phone":10,"phoneExt":10,"email":10},{"name":83,"role":80,"phone":10,"phoneExt":10,"email":10},"Sigrid Vik, MD",{"name":85,"role":80,"phone":10,"phoneExt":10,"email":10},"Martin Leth-Olsen, MD",{"name":87,"role":80,"phone":10,"phoneExt":10,"email":10},"Siv Ødegård, MD, PhD",{"name":89,"role":80,"phone":10,"phoneExt":10,"email":10},"Lina Ytrehus, MD",{"type":91,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[93],{"name":43,"class":6},"100565751",false,"NCT06646250","NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot","NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants","CE-NeoDoppler","Inclusion Criteria:\n\n* Open fontanelle\n* Healthy preterm or term born neonates\n* Neonates with a medical condition of interest according to the different cohort studies: patent ductus arteriosus, perinatal asphyxia, stroke, pulmonary hypertension, congenital heart condition or infection\u002Fsepsis\u002Fmeningitis\n* Neonates in need of procedures\n\nExclusion Criteria:\n\n* Caregivers not understanding\u002Fspeaking Norwegian or English\n* Caregivers not giving their consent",true,"ALL","0 Minutes","12 Months",{"count":106,"type":107},180,"ESTIMATED","OBSERVATIONAL","Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term\u002Fpremature infants and sick neonates. For many years, the ultrasound group in Trondheim has been at the forefront in the development of new ultrasound technology for the diagnosis and monitoring of disease. Several methods previously developed in this research group are today widely used in hospitals around the world. In this project the investigators aim to test a new ultrasound technology that allows continuous monitoring of cerebral blood flow in sick neonates and pre-term children. This technology was CE-certified in October 2022, and in this project the investigators will test the CE-certified version with the newest available approved software.",[111,112,113,114,115,116,117],"Preterm","Patent Ductus Arteriosus","Sepsis","Asphyxia","Stroke","Pulmonary Hypertension","Congenital Heart Disease",[119,120,121,122],"Cerebral Doppler","Monitoring","Continuous","Neonate","2026-04-22",{"date":125,"type":126},"2026-04-23","ACTUAL",{"date":128,"type":126},"2024-10-20",{"date":130,"type":107},"2029-12-31",{"name":5,"class":6},1]