[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perinatal-asphyxia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perinatal-asphyxia":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,82,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100540890","optimization-of-routine-obstetric-and-neonatal-care-in-the-management-of-severe-perinatal-asphyxia-in-term-or-near-term-newborns-analysis-of-sub-optimal-care-100540890",false,"NCT06322732","Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns: Analysis of Sub-optimal Care","OptiNeoCare","Inclusion Criteria:\n\n\\- Newborn at or near term (≥ 36 weeks of amenorrhea), considered to be alive at the onset of labor and presenting severe perinatal asphyxia\n\nSevere perinatal asphyxia is considered if\n\n1. Severity in its impact on the newborn:\n\n   • a neonatal death during the initial hospitalization, since birth and before a possible return home, before D28 \".\n\n   OR\n   * moderate to severe anoxic-ischemic encephalopathy OR\n   * a newborn hospitalized in the first week of life for hypoxic-ischemic encephalopathy or convulsions related to a perpartum event.\n\n   AND\n2. Biological perinatal asphyxia:\n\n   * a pH (arterial or, failing that, venous) ≤ 7.10 or base deficit ≥ 16mmol\u002FL or lactates ≥ 11mmol\u002FL during the first three hours of life OR\n   * In the absence of biological documentation of metabolic acidosis, an Apgar ≤ 5 to 5 minutes of life or the need for neonatal resuscitation (ventilatory support at birth and Apgar score ≤ 7 to 10 minutes of life).\n   * If none of the biological elements are available in the file, keep the clinical inclusion criteria below (In the absence of biological and clinical Apgar data (home delivery type), inclusion may be based on neonatal outcome (death - hypoxic ischemic encephalopathy - neonatal convulsions).\n\nExclusion Criteria\n\n* Fetal death in utero prior to hospital admission\n* Medical termination of pregnancy\n* Severe malformations with potential impact on child survival and development.\n* Neonatal encephalopathy not due to perinatal asphyxia","ALL","1 Month",{"count":19,"type":20},336,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to identify and analyze suboptimal perinatal (obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term.\n\nPerinatal asphyxia is a serious and often unexpected pathology, requiring urgent multidisciplinary care (obstetric - pediatric - intensive care, etc.) with a high level of technical expertise and care coordination. Because of its rarity and complexity, it may be subject to suboptimal care.\n\nThe aim of this study is to provide feedback within the center itself, coupled in 1\u002F3 of cases with a confidential investigation into the search for and understanding of suboptimal care.\n\nPrimary endpoint:\n\nFrequency of optimal or non-optimal maternal and neonatal management of hypoxic-ischemic encephalopathy (AIE) or neonatal death related to severe perinatal asphyxia.",[24],"Perinatal Asphyxia",[26,27,28,29,30],"Hypoxic-ischemic encephalopathy","perinatal asphyxia","neonatal death","suboptimal care","confidential inquiry","RECRUITING","2026-06-29",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2025-05-05",{"date":39,"type":20},"2027-01",{"name":41,"class":42},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":43},"100573513","early-phase-1-feasibility-and-safety-of-intranasally-administered-breast-milk-in-hie-100573513","NCT06747260","Feasibility and Safety of Intranasally Administered Breast Milk in HIE","Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy","F-NEO-BRIGHT","Inclusion Criteria:\n\n* Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia\n* ≥ 35. gestational week\n* \\\u003C 48 hours of life\n* Hypothermia treatment for 72 hours\n* Parental consent form\n\nExclusion Criteria:\n\n* Congenital malformation\n* Concurrent cerebral lesions\n* ECMO therapy\n* Contraindication of lactation\n* Mother unable or unwilling to provide fresh breast milk\n* Postpartum asphyxia","48 Hours",{"count":54,"type":20},10,"INTERVENTIONAL",[57],"EARLY_PHASE1","This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.",[60,61,62,63,64,24,65],"Hypoxic Ischaemic Encephalopathy (HIE)","Hypoxic Ischemic Encephalopathy of Newborn","Neonatal Encephalopathy","Neonatal Hypoxic Ischemic Encephalopathy","Brain Injury","Perinatal Asphyxia , Moderate to Severe HIE",[67,68,69,70,71,72],"Hypoxic-ischaemic encephalopathy","Neonatal encephalopathy","Perinatal asphyxia","Breast milk","Breast milk stem cells","Intranasal breast milk","2025-05-19",{"date":75,"type":35},"2025-05-22",{"date":77,"type":35},"2024-11-22",{"date":79,"type":20},"2030-01-01",{"name":81,"class":42},"Semmelweis University",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":52,"enrollmentInfo":90,"targetDuration":4,"studyType":55,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":43},"100573457","early-phase-1-intranasal-breast-milk-therapy-in-hie-100573457","NCT06746532","Intranasal Breast Milk Therapy in HIE","Neonatal Intranasal Breast Milk, Impact on Brain Growth in Hypoxic-ischemic Encephalopathy Therapy (NEO-BRIGHT)","NEO-BRIGHT","Inclusion Criteria:\n\n* Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia\n\n  ≥ 35. gestational week \\\u003C 48 hours of life\n* Hypothermia treatment for 72 hours\n* Parental consent form\n\nExclusion Criteria:\n\n* Congenital malformation\n* Concurrent cerebral lesions\n* ECMO therapy\n* Contraindication of lactation\n* Mother unable or unwilling to provide fresh breast milk\n* Postpartum asphyxia",{"count":91,"type":20},80,[57],"This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.",[95,62,24,63],"Hypoxic-Ischaemic Encephalopathy",[97,98,27,99,100,101],"HIE","intranasal breast milk","brain","breast milk stem cells","hypoxic-ischemic encephalopathy","2024-12-20",{"date":104,"type":35},"2024-12-24",{"date":106,"type":20},"2025-02-01",{"date":108,"type":20},"2030-12",{"name":81,"class":42},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":43},"100563060","quantification-of-brain-and-kidney-perfusion-before-during-and-after-hypothermia-treatment-in-neonates-with-perinatal-asphyxia-using-contrast-enhanced-ultrasound-100563060","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",{"count":117,"type":20},20,"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.",[24,120,121],"Hypothermia Treatment","Gestational Age Min. 36SSW","2024-09-20",{"date":124,"type":35},"2024-09-24",{"date":126,"type":35},"2024-06-24",{"date":128,"type":20},"2027-12-01",{"name":130,"class":42},"University of Erlangen-Nürnberg Medical School"]