[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583624":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":57,"locations":63,"responsibleParty":99,"collaborators":40,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":40,"maxAge":110,"enrollmentInfo":111,"targetDuration":40,"studyType":114,"phases":115,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":66,"whyStopped":40,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Instituto de Investigación Hospital Universitario La Paz","OTHER",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Dobutamine dose A","EXPERIMENTAL","Intravenous dobutamine will be administered at a dose of 5 mcg\u002Fkg\u002Fmin. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.",[13],"Drug: Intravenous dobutamine 5 mcg\u002Fkg\u002Fmin",{"label":15,"type":10,"description":16,"interventionNames":17},"Dobutamine dose B","Intravenous dobutamine will be administered at a dose of 7.5 mcg\u002Fkg\u002Fmin. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.",[18],"Drug: Intravenous dobutamine 7.5 mcg\u002Fkg\u002Fmin",{"label":20,"type":10,"description":21,"interventionNames":22},"Dobutamine dose C","Intravenous dobutamine will be administered at a dose of 10 mcg\u002Fkg\u002Fmin. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.",[23],"Drug: Intravenous dobutamine 10 mcg\u002Fkg\u002Fmin",{"label":25,"type":10,"description":26,"interventionNames":27},"Dobutamine dose D","Intravenous dobutamine will be administered at a dose of 12.5 mcg\u002Fkg\u002Fmin. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.",[28],"Drug: Intravenous dobutamine 12.5 mcg\u002Fkg\u002Fmin",{"label":30,"type":10,"description":31,"interventionNames":32},"Dobutamine dose E","Intravenous dobutamine will be administered at a dose of 15 mcg\u002Fkg\u002Fmin. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.",[33],"Drug: Intravenous dobutamine 15 mcg\u002Fkg\u002Fmin",[35,41,45,49,53],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Intravenous dobutamine 5 mcg\u002Fkg\u002Fmin","Intravenous dobutamine will be administered at a dose of 5 mcg\u002Fkg\u002Fmin.",[9],null,{"type":36,"name":42,"description":43,"armGroupLabels":44,"otherNames":40},"Intravenous dobutamine 7.5 mcg\u002Fkg\u002Fmin","Intravenous dobutamine will be administered at a dose of 7.5 mcg\u002Fkg\u002Fmin.",[15],{"type":36,"name":46,"description":47,"armGroupLabels":48,"otherNames":40},"Intravenous dobutamine 10 mcg\u002Fkg\u002Fmin","Intravenous dobutamine will be administered at a dose of 10 mcg\u002Fkg\u002Fmin.",[20],{"type":36,"name":50,"description":51,"armGroupLabels":52,"otherNames":40},"Intravenous dobutamine 12.5 mcg\u002Fkg\u002Fmin","Intravenous dobutamine will be administered at a dose of 12.5 mcg\u002Fkg\u002Fmin.",[25],{"type":36,"name":54,"description":55,"armGroupLabels":56,"otherNames":40},"Intravenous dobutamine 15 mcg\u002Fkg\u002Fmin","Intravenous dobutamine will be administered at a dose of 15 mcg\u002Fkg\u002Fmin.",[30],[58],{"name":59,"role":60,"phone":61,"phoneExt":40,"email":62},"Adelina Pellicer, MD","CONTACT","917277416","adelina.pellicer@salud.madrid.org",[64,81,91],{"facility":65,"status":66,"city":67,"state":40,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Hospital Universitario Quironsalud","RECRUITING","Madrid","28002","Spain","ES",{"type":72,"coordinates":73},"Point",[74,75],-3.70256,40.4165,{"lat":75,"lon":74},[78],{"name":79,"role":60,"phone":40,"phoneExt":40,"email":80},"Fernando Cabañas, MD","Fernando.cabanas@quironsalud.es",{"facility":82,"status":66,"city":67,"state":40,"zip":83,"country":69,"countryCode":70,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Hospital Universitario 12 de Octubre","28041",{"type":72,"coordinates":85},[74,75],{"lat":75,"lon":74},[88],{"name":89,"role":60,"phone":40,"phoneExt":40,"email":90},"María López, MD","maríamaestro@gmail.com",{"facility":92,"status":66,"city":67,"state":40,"zip":93,"country":69,"countryCode":70,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"Hospital Universitario La Paz","28046",{"type":72,"coordinates":95},[74,75],{"lat":75,"lon":74},[98],{"name":59,"role":60,"phone":61,"phoneExt":40,"email":62},{"type":100,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100583624","phase-1-dose-finding-for-dobutamine-during-transitional-circulation-in-very-preterm-infants-100583624",false,"NCT06878742","Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants","Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant","NeoCirc-002","Inclusion Criteria:\n\n* Born with up to 32(+6) weeks gestation\n* Presence of hemodynamic insufficiency, defined as SVC flow \\\u003C51 ml\u002Fkg\u002Fmin.\n* Provision of signed and dated informed consent form by father\u002Fmother or legally designated representative, which can be given antenatally.\n\nExclusion Criteria:\n\n* Neonates considered non-viable, with a clinical decision not to provide life support\n* Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment\n* Infants already on dobutamine treatment\n* Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects)\n* Infants with chromosomal anomalies\n* Lack of parental signed informed consent","ALL","72 Hours",{"count":112,"type":113},30,"ESTIMATED","INTERVENTIONAL",[116,117],"PHASE1","PHASE2","Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth).",[120,121],"Infant, Premature, Diseases","Circulatory and Respiratory Physiological Phenomena",[123,124],"Hemodynamic insuffiency","Low superior vena cava flow","2025-03-10",{"date":127,"type":128},"2025-03-17","ACTUAL",{"date":130,"type":128},"2024-06-24",{"date":132,"type":113},"2029-06",{"name":5,"class":6},3]