[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-aspiration-pneumonia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-aspiration-pneumonia":25},{"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":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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100573765","evaluating-the-safety-and-performance-of-the-minilung-petite-kit-in-neonatal-and-pediatric-patients-with-acute-respiratory-and-cardiac-failure-100573765",false,"NCT06750536","Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure","PETIT","Inclusion criteria\n\n* Informed consent signed and dated by parents or legal representative and investigator\u002Fauthorized physician\n* Patients ≥2- ≤8 kg bodyweight to be treated with the MiniLung petite kit\n* Acute severe respiratory and\u002For cardiopulmonary failure with an ECMO indication\n\nExclusion criteria:\n\n* Participation in an interventional clinical study during the preceding 30 days that could interfere with the ECLS therapy\n* Previous participation in the same study\n* Prematurity (\\\u003C34 weeks gestational age)\n* Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT)\n* Impossibility of systemic anticoagulation","ALL","8 Months",{"count":19,"type":20},20,"ESTIMATED","OBSERVATIONAL","This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.\n\nThe main question it aims to answer is (study hypotheses):\n\nVeno-venous (VV) and veno-arterial (VA) Extracorporeal Membrane Oxygenation (ECMO) using the MiniLung petite kit is safe and improves gas exchange (oxygenation and CO2 removal) and hemodynamic stabilization in neonatal and pediatric patients with severe acute respiratory and\u002For cardiopulmonary failure within 24 hours compared to the treatment before VV or VA ECMO initiation and maintain a life-sustaining condition.",[24,25,26,27],"Extracorporeal Membrane Oxygenation Complication","Neonatal Aspiration Pneumonia","Acute Respiratory Failure","Acute Lung Injury",[29,30,31],"Extracorporeal Membrane Oxygenation","Neonatal and pediatric patients","MiniLung petite kit","RECRUITING","2025-12-18",{"date":35,"type":36},"2025-12-24","ACTUAL",{"date":38,"type":36},"2025-10-12",{"date":40,"type":20},"2026-12",{"name":42,"class":43},"Xenios AG","INDUSTRY",2]