[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640493":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":42,"locations":50,"responsibleParty":65,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":98,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Turin, Italy","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Taurolidine 2% lock","EXPERIMENTAL","Lock with a 2% taurolidine solution for a duration of 30 minutes every 48 hours, from CVC insertion until its removal.\n\nThe lock will be performed according to the following procedure:\n\n1. infusion of lock solution in an amount equal to the dead space of the infusion line (calculated by summing the dead space of the catheter and all add-on devices present between the catheter hub and the access point to the infusion line); the access point to the infusion line must be as proximal as possible to the catheter.\n2. non-use of the infusion line for 30 minutes from the time of lock.\n3. aspiration of the lock solution at the end of the 30 minutes.\n4. restoration of normal use of the infusion line after flushing with normal saline equal to 2 times the dead space of the infusion line (calculated as described above).\n\nIn the case of non-blood-returning catheters, step 3 will not be feasible, and the procedure will proceed directly to step 4.",[13],"Device: Taurolidine 2% lock",{"label":15,"type":16,"description":17,"interventionNames":18},"Normal saline (0.9% sodium chloride solution) lock","PLACEBO_COMPARATOR","Lock with normal saline for a duration of 30 minutes every 48 hours, from CVC insertion until its removal.\n\nThe lock will be performed according to the following procedure:\n\n1. infusion of lock solution in an amount equal to the dead space of the infusion line (calculated by summing the dead space of the catheter and all add-on devices present between the catheter hub and the access point to the infusion line); the access point to the infusion line must be as proximal as possible to the catheter.\n2. non-use of the infusion line for 30 minutes from the time of lock.\n3. aspiration of the lock solution at the end of the 30 minutes.\n4. restoration of normal use of the infusion line after flushing with normal saline equal to 2 times the dead space of the infusion line (calculated as described above).\n\nIn the case of non-blood-returning catheters, step 3 will not be feasible, and the procedure will proceed directly to step 4.",[19],"Other: Normal saline lock",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Lock with a 2% taurolidine solution for a duration of 30 minutes every 48 hours, from CVC insertion until its removal, performed in newborns with epicutaneo-caval catheters (ECCs), femoral inserted central catheters (FICCs), or centrally inserted central catheters (CICCs).",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Normal saline lock","Lock with normal saline for a duration of 30 minutes every 48 hours, from CVC insertion until its removal, performed in newborns with epicutaneo-caval catheters (ECCs), femoral inserted central catheters (FICCs), or centrally inserted central catheters (CICCs).",[15],[31,34,36,39],{"name":32,"affiliation":5,"role":33},"Elena Maggiora, MD","STUDY_DIRECTOR",{"name":35,"affiliation":5,"role":33},"Francesco Cresi, MD PhD",{"name":37,"affiliation":5,"role":38},"Giulia Maiocco, MD","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":41},"Alessandra Coscia, MD PhD","STUDY_CHAIR",[43,47],{"name":35,"role":44,"phone":45,"phoneExt":25,"email":46},"CONTACT","+390113135781","francesco.cresi@unito.it",{"name":37,"role":44,"phone":48,"phoneExt":25,"email":49},"+390113134437","giulia.maiocco@unito.it",[51],{"facility":52,"status":25,"city":53,"state":25,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Sant'Anna Hospital, University of Turin","Turin","10126","Italy","IT",{"type":58,"coordinates":59},"Point",[60,61],7.68682,45.07049,{"lat":61,"lon":60},[64],{"name":35,"role":44,"phone":45,"phoneExt":25,"email":46},{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100640493","neonatal-catheter-lock-for-infection-prevention-100640493",false,"NCT07585188","Neonatal Catheter Lock for Infection Prevention","Taurolidine Lock for Prevention of Central-Line Associated Bloodstream Infections in Neonates: A Triple-blind Randomized Controlled Trial","Neo-CLIP","Inclusion Criteria:\n\n* presence of a CVC (ECC, CICC, or FICC) for at least 48 hours\n* absence of systemic antibiotic therapy in the 48 hours preceding enrollment\n\nExclusion Criteria:\n\n* presence of an umbilical venous catheter\n* suspected thrombophilic disorder","ALL","1 Day","120 Days",{"count":79,"type":80},576,"ESTIMATED","INTERVENTIONAL",[83],"NA","For newborns admitted to Neonatal Intensive Care Units (NICUs), one of the main risk factors for late-onset sepsis is the presence of a central venous catheter (CVC), which is often essential for the administration of medications and parenteral nutrition in this patient population. From a nosological perspective, sepsis associated with the presence of a venous catheter is defined by two acronyms: CRBSI (Catheter-Related Bloodstream Infection - a microbiological definition) and CLABSI (Central Line-Associated Bloodstream Infection - an epidemiological definition).\n\nAmong preventive strategies for CRBSI\u002FCLABSI, antibiotic or antimicrobial catheter lock solutions - instilled in a volume equivalent to the catheter dead space and retained within the lumen until the next use - have demonstrated favorable efficacy in reducing infection risk.\n\nTaurolidine 2% is considered a preferred agent due to its broad-spectrum antibacterial and antifungal activity and its lack of association with the development of antimicrobial resistance.\n\nHowever, its prophylactic use in neonates remains largely investigational, with current evidence limited to small, retrospective observational studies involving catheters ≥3 Fr (e.g., femoral inserted central catheters - FICCs, centrally inserted central catheters - CICCs, and umbilical venous catheters).\n\nIn NICUs, epicutaneo-caval catheters (ECCs) are the most commonly used central venous access devices and represent a major source of catheter-related infections. Despite this, the use of antimicrobial lock prophylaxis in ECCs has been limited by concerns regarding catheter occlusion, given their smaller diameter (≤2 Fr). Nevertheless, available evidence indicates that short-duration locks, when combined with meticulous infusion line management, can be safely implemented without increasing the risk of catheter occlusion.\n\nThe aim of the study is to evaluate the efficacy of 2% taurolidine lock in the prevention of CLABSI\u002FCRBSI in neonates with CVC (ECC, FICC, or CICC).",[86,87,88],"CLABSI - Central Line Associated Bloodstream Infection","CRBSI - Catheter Related Bloodstream Infection","Neonatal Sepsis, Late-Onset",[90,91,92,93,94,95,96,97],"Taurolidine","Catheter lock therapy","Epicutaneo-caval catheter","Femoral inserted central catheters","Centrally inserted central catheters","Neonatal Intensive Care Unit","Newborn","Parenteral nutrition","NOT_YET_RECRUITING","2026-05-08",{"date":101,"type":102},"2026-05-13","ACTUAL",{"date":104,"type":80},"2026-10",{"date":106,"type":80},"2029-10",{"name":5,"class":6},1]