[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"erythropoietin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:erythropoietin":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100469621","phase-3-erythropoietin-for-neonatal-encephalopathy-in-lmic-embrace-trial-100469621",false,"NCT05395195","Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)","Erythropoietin Monotherapy for Brain Regeneration in Neonatal Encephalopathy in Low and Middle-Income Countries","EMBRACE","Inclusion Criteria (all of below should be met)\n\n* Inborn babies born at a gestational age greater than or equal to 36 weeks, with a birth weight \\>=1.8 kg\n* At least one of the following: need for continued resuscitation at 5 minutes of age; 5-minute Apgar score \\\u003C 6; metabolic acidosis (pH \\\u003C 7.0; base deficit \\> 16 mmol\u002FL) in cord or blood gas within the first hour of birth.\n* Moderate or severe neonatal encephalopathy on modified Sarnat staging performed between 1 to 6 hours after birth.\n\nExclusion Criteria:\n\n* Imminent death at the time of recruitment\n* Babies born at home or those admitted after 6 hours of birth.\n* Major life-threatening congenital malformations\n* Head circumference \\\u003C30 cm at birth\n* Babies undergoing induced hypothermia\n* Migrant family or parents unable\u002Funlikely to come back for follow-up at 18 months\n* Sentinel event and encephalopathy occurred only after birth\n* Unable to consent in primary language of parent(s)","ALL","1 Hour","6 Hours",{"count":21,"type":22},504,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year. Cooling therapy in the context of modern tertiary intensive care improves outcome after NE in high-income countries. However, the uptake and applicability of cooling therapy in LMICs is poor, due to the lack of intensive care and transport facilities to initiate and administer the treatment within the six-hours window after birth as well as the absence of safety and efficacy data on hypothermia for moderate or severe NE.\n\nErythropoietin (Epo) is a promising neuroprotectant with both acute effects (anti-inflammatory, anti-excitotoxic, antioxidant, and antiapoptotic) and regenerative effects (neurogenesis, angiogenesis, and oligodendrogenesis),which are essential for the repair of injury and normal neurodevelopment when used as a mono therapy in pre-clinical models (i.e without adjunct hypothermia).\n\nThe preclinical data on combined use of Eythropoeitin and hypothermia is less convincing as the mechanisms overlap. Thus, the HEAL (High dose erythropoietin for asphyxia and encephalopathy) trial, a large phase III clinical trial involving 500 babies with with encephalopathy reported that that Erythropoietin along with hypothermia is not beneficial.\n\nIn contrast, the pooled data from 5 small randomized clinical trials (RCTs) (n=348 babies), suggests that Epo (without cooling therapy) reduce the risk of death or disability at 3 months or more after NE (Risk Ratio 0.62 (95% CI 0.40 to 0.98). Hence, a definitive trial (phase III) for rigorous evaluation of the safety and efficacy of Epo monotherapy in LMIC is now warranted.",[28,29,30],"Encephalopathy","Erythropoietin","Newborn Asphyxia","RECRUITING","2024-03-18",{"date":34,"type":35},"2024-03-19","ACTUAL",{"date":37,"type":35},"2022-12-31",{"date":39,"type":22},"2026-12-01",{"name":41,"class":42},"Imperial College London","OTHER",10]