[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"asphyxia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:asphyxia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100503542","phase-4-hydrocortisone-therapy-optimization-during-hypothermia-treatment-in-asphyxiated-neonates-100503542",false,"NCT05836610","Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates","Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates - a Pharmacokinetic Study","UniCort","Inclusion Criteria:\n\n* gestational age ≥ 36 weeks\n* provision of whole-body hypothermia treatment (as described by Azzopardi et al.)\n* presence of systemic hypotension (defined as a mean arterial pressure less than the gestational age in weeks)\n* indication for hydrocortisone treatment during hypothermia by the attending physician\n* indwelling arterial catheter to take blood samples without additional painful punctures: umbilical arterial catheter or peripheral arterial catheter\n* written informed parental consent\n\nExclusion Criteria:\n\n* infants who are expected to be \\> 6 hours of age (not suitable for cooling)\n* critical congenital abnormalities\n* genetic disease\n* signed informed consent is unavailable","ALL","72 Hours",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to hydrocortisone supplementation while receiving conventional inotropic therapy as needed.\n\nThe hypothesis is that a detailed study of hydrocortisone pharmacokinetics during therapeutic hypothermia would help to personalize steroid supplementation in asphyxiated neonates. As the overall metabolic rate decreases with lower body temperature, drug metabolism is likely to be reduced as well, and lower doses, or less frequent dosing will be sufficient to achieve the targeted steroid range and biological effects in asphyxiated neonates with relative adrenal insufficiency. Thus, the investigators are planning to measure initial, baseline serum cortisol levels and serial serum cortisol levels after hydrocortisone supplementation in cooled asphyxiated neonates.",[27,28,29,30],"Hypoxic-Ischemic Encephalopathy","Asphyxia","Hypotension","Circulatory Failure Neonatal",[32,33,34,35,27,28],"Hypothermia treatment","Relative adrenal insufficiency","Hydrocortisone supplementation","Hydrocortisone pharmacokinetics","RECRUITING","2026-04-23",{"date":39,"type":40},"2026-04-28","ACTUAL",{"date":42,"type":40},"2021-09-21",{"date":44,"type":21},"2027-09",{"name":46,"class":47},"Semmelweis University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":71,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":48},"100565751","neodoppler-new-ultrasound-technology-for-continuous-monitoring-of-cerebral-circulation-pilot-100565751","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,"0 Minutes","12 Months",{"count":61,"type":21},180,"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.",[65,66,67,28,68,69,70],"Preterm","Patent Ductus Arteriosus","Sepsis","Stroke","Pulmonary Hypertension","Congenital Heart Disease",[72,73,74,75],"Cerebral Doppler","Monitoring","Continuous","Neonate","2026-04-22",{"date":37,"type":40},{"date":79,"type":40},"2024-10-20",{"date":81,"type":21},"2029-12-31",{"name":83,"class":47},"St. Olavs Hospital"]