[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554459":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":18,"studyPopulation":32,"armGroups":18,"interventions":18,"overallOfficials":18,"centralContacts":33,"locations":39,"responsibleParty":105,"collaborators":18,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":18,"maxAge":116,"enrollmentInfo":117,"targetDuration":18,"studyType":120,"phases":18,"briefSummary":121,"conditions":122,"keywords":18,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Ferrer Internacional S.A.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":18},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Characteristics of neonates receiving treprostinil in the clinical practice.","Sex (male\u002Ffemale) ; Gestational Age (weeks) ; Birth Weight (g) ; Apgar (1 and 5 min, 0-10) and Time from birth to treprostinil initiation (h)","From baseline to Day 30 after last dose of treprostinil",{"measure":14,"description":15,"timeFrame":12},"Treprostinil-specific treatment patterns.","Prior concomitant treatments, treprostinil route, treprostinil dose(s) (mg\u002Fml) and treprostinil treatment duration (days).",{"measure":17,"description":18,"timeFrame":12},"Number of participants with treatment-related adverse events to evaluate safety.",null,[20,22,26],{"measure":21,"description":18,"timeFrame":12},"Composite endpoint of absence of complications through Day 14 after the index date.",{"measure":23,"description":24,"timeFrame":25},"Description of the clinical outcomes from treprostinil start day (i.e., Day 0) to Day 14 and at Day 30 after last dose of treprostinil.","Evolution of pre- and post-ductal oxygen saturation (SpO2); oxygen partial pressure (PO2); clinical laboratory parameters and fraction of inspired oxygen (FiO2) at times 0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil.","0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil (if applicable).",{"measure":27,"description":18,"timeFrame":28},"Description of neurodevelopmental progress over 2 years after treprostinil initiation through a Global Clinical Impression Scale.","From day 30 after treprostinil treatment to Year 2 after last dose of treprostinil",{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":30,"timePerspective":31,"maskingInfo":18},"COHORT","OTHER","Approximately 60 newborns with PH (of whom at least 40 newborns with persistent pulmonary hypertension of the newborn \\[PPHN\\]) are expected to be included.",[34],{"name":35,"role":36,"phone":37,"phoneExt":18,"email":38},"Ferrer MedInfo","CONTACT","609850565","medinfo@ferrer.com",[40,60,75,90],{"facility":41,"status":42,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"CHU Lyon (HCL) - Hopital Femme Mère Enfant","RECRUITING","Bron","69500","France","FR",{"type":48,"coordinates":49},"Point",[50,51],4.91303,45.73865,{"lat":51,"lon":50},[54,58],{"name":55,"role":36,"phone":56,"phoneExt":18,"email":57},"Marine Butin, Medical Doctor","+33 (0)4 27 85 52 84","marine.butin@chu-lyon.fr",{"name":55,"role":59,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"facility":61,"status":42,"city":62,"state":18,"zip":63,"country":45,"countryCode":46,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant","Grenoble","38043",{"type":48,"coordinates":65},[66,67],5.71479,45.17869,{"lat":67,"lon":66},[70,74],{"name":71,"role":36,"phone":72,"phoneExt":18,"email":73},"Amélie Desrumaux, Medical Doctor","+33(0)4 76 76 55 03","ADesrumaux@chu-grenoble.fr",{"name":71,"role":59,"phone":18,"phoneExt":18,"email":18},{"facility":76,"status":42,"city":77,"state":18,"zip":78,"country":45,"countryCode":46,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"CHU Lille - Clinique de Néonatalogie","Lille","59000",{"type":48,"coordinates":80},[81,82],3.05512,50.63391,{"lat":82,"lon":81},[85,89],{"name":86,"role":36,"phone":87,"phoneExt":18,"email":88},"Kevin Leduc, Medical Doctor","+33 03 20 44 58 89","Kevin.LEDUC@chu-lille.fr",{"name":86,"role":59,"phone":18,"phoneExt":18,"email":18},{"facility":91,"status":42,"city":92,"state":18,"zip":93,"country":45,"countryCode":46,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"CHU de Toulouse Hopital des enfants - Réanimation Néonatale","Toulouse","31300",{"type":48,"coordinates":95},[96,97],1.44367,43.60426,{"lat":97,"lon":96},[100,104],{"name":101,"role":36,"phone":102,"phoneExt":18,"email":103},"Sophie Breinig, Medical Doctor","+33 (0)5 34 55 84 77","breinig.s@chu-toulouse.fr",{"name":101,"role":59,"phone":18,"phoneExt":18,"email":18},{"type":106,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100554459","treprostinil-in-newborns-with-pulmonary-hypertension-a-non-interventional-study-to-collect-data-on-drug-utilization-safety-and-effectiveness-100554459",false,"NCT06499363","Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness","Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.","NEPHY","Inclusion Criteria:\n\n1. Newborn infants who received at least one dose of IV or SC treprostinil as per clinical practice within 5 years from the moment of data collection.\n2. Aged up to 44 weeks after conception at treprostinil initiation.\n3. Pulmonary hypertension (PH) or suspicion of PH at the moment of treprostinil initiation.\n4. Parent(s) or legally authorized representative(s) provides non-opposition consent for the patient participation in the study.\n5. Newborn infants affiliated to French social security.\n\nExclusion Criteria:\n\n* None.","ALL","44 Weeks",{"count":118,"type":119},60,"ESTIMATED","OBSERVATIONAL","This observational study will seek to describe the uses and safety and efficacy outcomes of treprostinil in clinical practice in patients with persistent pulmonary hypertension (PPHN).",[123],"Persistent Pulmonary Hypertension of Newborn","2025-09-02",{"date":126,"type":127},"2025-09-03","ACTUAL",{"date":129,"type":127},"2025-02-25",{"date":131,"type":119},"2027-12-31",{"name":5,"class":6},4]