[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-sepsis-late-onset\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-sepsis-late-onset":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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":21,"type":22},576,"ESTIMATED","INTERVENTIONAL",[25],"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).",[28,29,30],"CLABSI - Central Line Associated Bloodstream Infection","CRBSI - Catheter Related Bloodstream Infection","Neonatal Sepsis, Late-Onset",[32,33,34,35,36,37,38,39],"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":43,"type":44},"2026-05-13","ACTUAL",{"date":46,"type":22},"2026-10",{"date":48,"type":22},"2029-10",{"name":50,"class":51},"University of Turin, Italy","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":62},"100575468","vancomycin-reduction-practices-vrp-in-the-nicu-100575468","NCT06772675","Vancomycin Reduction Practices (VRP) in the NICU","Implementing Vancomycin Reducing Practices (VRP) in Preterm Infants","Inclusion Criteria:\n\n* Level III NICU\n* Affiliated with Kaiser Permanente Northern California (KPNC) or Children's Hospital of Philadelphia Newborn Care Network (CNBCN)\n* Recruited by study team\n\nExclusion Criteria:\n\n* Site not recruited for the study","18 Years",{"count":62,"type":22},13,[25],"This multi-center, cluster randomized study aimed at improving implementation of vancomycin reducing practices (VRP) in neonatal intensive care units (NICUs). Sites will be recruited and randomized to receive either external facilitation or no external facilitation to assess the effect on center-level fidelity to the core components of VRP implementation. Interventions available to both study arms are directed at hospital staff and includes identification of local champions, educational outreach, unit-level audit \\& feedback, and use of a clinical decision support tool.",[66,30,67],"Antibiotic Stewardship","Vancomycin",[69],"implementation study","RECRUITING","2025-12-18",{"date":73,"type":44},"2025-12-24",{"date":75,"type":44},"2025-06-02",{"date":77,"type":22},"2027-09",{"name":79,"class":51},"Children's Hospital of Philadelphia",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100604637","amniotic-fluid--the-preterm-gut-100604637","NCT07152106","Amniotic Fluid & the Preterm Gut","The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study","AMFIBIE","Inclusion Criteria:\n\n* Maternal age ≥16 years\n* Written informed consent\n* Successful collection of amniotic fluid\n\nExclusion Criteria:\n\n* Pregnancies complicated by fetal congenital and\u002For chromosomal abnormalities.\n* Insufficient proficiency of Dutch or English language",true,"FEMALE","16 Years",{"count":92,"type":22},275,"OBSERVATIONAL","Background:\n\nNecrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations. An important yet understudied contributor in the development of the gastrointestinal tract (GIT) is amniotic fluid (AF). Knowledge is lacking on the critical shifts that may occur in AF in extremely preterm birth. The aim of the current study is to assess the composition of AF using advanced biomedical techniques. Secondary objectives are to assess AF profiles of infants with chorioamnionitis (CAM) and\u002For fetal growth restriction (FGR), assess key metabolites across gestation, correlate AF profiles with neonatal outcomes, and explore associations with early gut microbiota.\n\nMethods:\n\nln this multicenter, prospective, cohort study, AF (\\~5 mL) will be collected from obstetric patients delivering their infants extremely preterm (gestational age (GA) 24+0\u002F7-27+6\u002F7 weeks, n=125), either during vaginal delivery or cesarean section (CS). Additionally, AF samples will be collected from a reference group (n=150), including early midtrimester (GA \\\u003C23+\u002F7 weeks), very early and moderate to late preterm (GA 28+0\u002F6-36+6\u002F7 weeks), and full-term pregnancies (GA 37+0\u002F7-41+6\u002F7 weeks). Thorough characterization of AF will be conducted, including microbial profiling and metabolomics. Microbiota profiling of neonatal fecal samples will be conducted to assess the association between AF and early neonatal gut colonization patterns.\n\nDiscussion and expected results:\n\nAF profiles associated with CAM and\u002For FGR in extremely preterm infants are expected to be identified, as well as relevant associations with neonatal health outcomes (including NEC and sepsis) and early neonatal gut colonization patterns. The current study will not only increase the understanding of the GIT development and the pathogenesis of NEC and sepsis but may also aid in the identification of high-risk infants. In the future, these findings may facilitate early targeted microbiota-based interventions to prevent disease progression and ultimately improve clinical outcomes.",[96,97,98,99,30,100,101,102],"Chorioamnionitis","Chorioamnionitis Affecting Fetus or Newborn","Necrotizing Enterocolitis of Newborn","Neonatal Sepsis, Early-Onset","Fetal Growth Restriction (FGR)","Preterm Birth Complication","Prematurity Complications","2025-08-28",{"date":105,"type":44},"2025-09-03",{"date":107,"type":44},"2024-10-14",{"date":109,"type":22},"2027-10-14",{"name":111,"class":51},"Maxima Medical Center",2]