[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-asphyxia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-asphyxia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100478774","phase-2-assess-safety-and-efficacy-of-sovateltide-in-hypoxic-ischemic-encephalopathy-100478774",false,"NCT05514340","Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy","A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase-II Trial to Assess Safety, and Efficacy of Sovateltide in the Treatment of Hypoxic-ischemic Encephalopathy in Neonates","Inclusion Criteria:\n\n1. Either sex with ≥ 36 weeks of gestational age\n2. Receiving supportive management for perinatal asphyxia\n3. Perinatal depression, based on at least one of the following:\n\n   * Apgar score of \\\u003C5 at 10 minutes\n   * Need for resuscitation (chest compressions or mechanical ventilation) at birth\n   * pH \\\u003C7.00 or base deficit ≥ 16 mmol\u002Fliter in the cord or arterial blood within 60 minutes of birth\n   * Moderate\u002Fsevere encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth.\n4. Informed consent by one of the parents or a legal representative\n\nExclusion Criteria:\n\n1. Gestational age \\\u003C36 weeks\n2. Admitted to hospital 12-hours after birth\n3. A genetic or congenital condition that affects neuronal development\n4. TORCH infection\n5. Neonatal sepsis\n6. Complex congenital heart disease\n7. Severe dysmorphic feature\n8. Microcephaly (head circumference \\\u003C 2 Standard Deviations below mean for gestational age)","ALL",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a \"Treatment for hypoxic-ischemic encephalopathy in neonates,\" which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.",[25,26,27],"Hypoxic-Ischemic Encephalopathy","Neonatal Asphyxia","Neonatal Encephalopathy",[25,29,27],"Cerebral Asphyxia","RECRUITING","2025-12-26",{"date":33,"type":34},"2025-12-31","ACTUAL",{"date":36,"type":34},"2023-09-06",{"date":38,"type":19},"2026-12",{"name":40,"class":41},"Pharmazz, Inc.","INDUSTRY",4,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100589259","face-mask-vs-laryngeal-mask-in-neonatal-resuscitation-100589259","NCT06952088","Face Mask vs Laryngeal Mask in Neonatal Resuscitation","Face Mask vs Laryngeal Mask in Neonatal Resuscitation: A Study on Manikins","ManiMask2025","Inclusion Criteria:\n\n* Healthcare Workers (physicians, nurses, and midwives) of the Neonatal Unit and Delivery Room of Fondazione Policlinico Gemelli Hospital IRCCS Rome\n* Signature of an informed consent\n\nExclusion Criteria:\n\n* Healthcare Workers (physicians, nurses, and midwives) NOT of the Neonatal Unit and Delivery Room of Fondazione Policlinico Gemelli Hospital IRCCS Rome\n* Failure to sign up for informed consent",true,{"count":53,"type":19},150,[55],"NA","The goal of this single-centre interventional study without medication neither device (for procedure) is to improve training of health care personnel (physicians, nurses, and midwives) on neonatal resuscitation through manikin simulation.\n\nThe main questions it aims to answer are:\n\n* Is it possible to compare the ease of use and speed of application of the laryngeal mask versus the face mask in ventilating the newborn during simulated manikin training?\n* What are the differences in the time required to achieve optimal skills in using the two masks?\n* What is health care personnel's level of confidence in using laryngeal mask versus face mask?",[58,26],"Neonatal Complication","NOT_YET_RECRUITING","2025-04-23",{"date":62,"type":34},"2025-04-30",{"date":64,"type":19},"2025-05-01",{"date":66,"type":19},"2025-08-31",{"name":68,"class":69},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",1]