[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550164":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":31,"responsibleParty":48,"collaborators":19,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":19,"maxAge":59,"enrollmentInfo":60,"targetDuration":19,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":19,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"study group","All infants undergoing blood transfusions will be enrolled in the study",[12],"Diagnostic Test: lung ultrasound",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DIAGNOSTIC_TEST","lung ultrasound","Lung ultrasound examinations will be performed within 6 hours before and after blood transfusion to assess interstitial-alveolar fluid retention and calculate a LUS score",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Stefano Nobile, MD, PhD, MSc","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","+39 06 30151","stefano.nobile@policlinicogemelli.it",{"name":30,"role":26,"phone":19,"phoneExt":19,"email":28},"Stefano Nobile",[32],{"facility":33,"status":34,"city":35,"state":19,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Fondazione Policlinico Gemelli IRCCS","RECRUITING","Roma","00168","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],11.10642,44.99364,{"lat":43,"lon":42},[46],{"name":22,"role":26,"phone":47,"phoneExt":19,"email":28},"+390630151",{"type":49,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100550164","respiratory-trends-during-blood-transfusions-in-newborns-100550164",false,"NCT06443515","Respiratory Trends During Blood Transfusions in Newborns.","Evaluation of Respiratory Trends During Blood Transfusions in Newborns.","ARTE","Inclusion Criteria:\n\n* admitted newborns requiring blood transfusions as per local practice and\u002For international guidelines\n\nExclusion Criteria:\n\n* newborns with major malformations\n* need for palliative care\n* lack of informed consent","ALL","1 Month",{"count":61,"type":62},71,"ESTIMATED","INTERVENTIONAL",[65],"NA","The prevalence of transfusion reactions is between 1 and 11% of transfusions. Most reactions are mild and do not pose a life-threatening risk to the patient. More serious problems may be the only manifestations that lead to suspicion of a transfusion reaction.\n\nMost noninfectious transfusion reactions are immune-mediated. Two main types of reactions can be distinguished: TACO (transfusion associated cardiac overload, which is a cardiogenic pulmonary edema) and TRALI (transfusion related acute lung injury, non-cardiogenic pulmonary edema).\n\nAlthough TRALI are diagnoses of exclusion, the presence of noncardiogenic pulmonary edema and respiratory problems in the vicinity of blood product transfusions should raise suspicion. Other signs of TRALI are hypotension and tachycardia, while in TACO arterial hypertension with positive water balance can be observed.\n\nAccording to previous reports, the prevalence of transfusion reactions in the neonatal population is approximately 8%. Factors associated with these reactions are low birth weight and low gestational age. However, diagnostic criteria of respiratory transfusion reactions are not uniform across studies, and often the generic terms \"acute lung injury\" have been used.\n\nTherefore, the primary objective of this study is to evaluate the respiratory trend during blood transfusions; secondary objectives are the study of risk factors for the development of respiratory worsening and the possible association with complications.",[68,69,70,71],"Blood Transfusion Complication","Blood Transfusion Associated Adverse Reactions","Respiratory Complication","Respiratory Morbidity","2024-09-23",{"date":74,"type":75},"2024-09-24","ACTUAL",{"date":77,"type":75},"2024-07-01",{"date":79,"type":62},"2026-01-15",{"name":5,"class":6},1]