[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523815":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":62,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":26,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Presepsin-guided therapy","EXPERIMENTAL","The decision to start empirical antibiotics in this group will be based on presepsin measurement within four hours after birth. When the presepsin value is above the cut-off value of 645 pg\u002Fml, antibiotics will be ordered and administered within 4 hours of life and discontinued following the criteria of the Dutch EOS guideline. When the presepsin level is below the cut-off value of 645 pg\u002Fml, the treating physician will not start antibiotic treatment. These infants will be closely observed for at least 72 hours. In case of deterioration of the clinical condition within this observation period, the clinician can decide to perform a sepsis evaluation and start with antibiotic treatment.",[13],"Diagnostic Test: Presepsin",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","ACTIVE_COMPARATOR","Standard care according to the Dutch EOS guideline. Presepsin will be determined with the treating physician blinded for the test result. In the Dutch EOS guideline maternal and neonatal risk factors for EOS are categorized as red flags or minor criteria. In the presence of 1 red flag or ≥ 2 minor criteria it is advised to perform a blood culture (= sepsis evaluation) and start empirical antibiotics for EOS suspicion. Antibiotic treatment will be advised to discontinue when blood culture turns back negative, reassuring the infants clinical condition with no other indicators of possible infection (e.g. CRP).",[19],"Diagnostic Test: Standard Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Presepsin","Umbilical cord blood or blood from the first routine venous puncture within four hours after birth will be used for presepsin determination. Presepsin measurement can be performed in 100 μl plasma with \"PATHFAST™ Presepsin\" which is a rapid chemiluminescent enzyme immunoassay (Mitsubishi Chemical Medience corporation, Tokyo, Japan) with results available within 15 minutes.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Care","Standard care according to the Dutch EOS guideline",[15],[32],{"name":33,"affiliation":34,"role":35},"Douwe Visser, MD PhD","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+31205669111","d.h.visser@amsterdamumc.nl",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Charlotte Nusman, MD PhD","c.m.nusman@amsterdamumc.nl",[45],{"facility":34,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Amsterdam","North Holland","1105 AZ","Netherlands","NL",{"type":53,"coordinates":54},"Point",[55,56],4.88969,52.37403,{"lat":56,"lon":55},[59,61],{"name":33,"role":38,"phone":60,"phoneExt":26,"email":40},"0031205669111",{"name":42,"role":38,"phone":60,"phoneExt":26,"email":43},{"type":35,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Douwe Visser","Principal Investigator","100523815","presepsin-to-safely-reduce-antibiotics-in-preterm-infants-100523815",false,"NCT06100614","Presepsin to Safely Reduce Antibiotics in Preterm Infants","Presepsin to Safely Reduce Antibiotics in Preterm Infants: a Randomized Controlled Trial","PRESAFE","Inclusion Criteria:\n\n* Infants born at a gestational age of 24+0 to 31 6\u002F7 weeks\n* Moderate risk of early-onset neonatal sepsis, i.e. infants who should be treated with empirical antibiotics based on the Dutch EOS guideline.\n\nExclusion Criteria:\n\n* low risk of early-onset neonatal sepsis who do not have an indication for empirical antibiotics according to the Dutch EOS guideline;\n* high risk of early-onset neonatal sepsis defined as:\n\n  1. suspected or confirmed diagnosis of maternal sepsis;\n  2. suspected or proven EOS in other infants (in case of multiple births) or infants born to mothers with previous infant with GBS disease\u002Finfection;\n  3. unexplained respiratory insufficiency requiring invasive mechanical ventilation and FiO2\\>0.40 or non-invasive ventilation with FiO2 \\>0.60 at time of randomization;\n  4. ongoing hemodynamic instability requiring inotrope medication or more than one 10 ml\u002Fkg fluid bolus at time of randomization;\n  5. strong clinical concern for sepsis due to physical exam findings (i.e. minimal responsiveness, poor tone).","ALL",{"count":75,"type":76},900,"ESTIMATED","INTERVENTIONAL",[79],"NA","In the Netherlands, more than 85% of the preterm infants born \\\u003C32 weeks gestational age get antibiotics directly after birth because of the risk of infection with a bacteria. However, only 1 in 70 of these preterm babies actually has a bacterial infection. The use of antibiotics after birth can lead to problems on short term (bowel infection, infection with a bacteria later on or death) or long term (asthma, allergy, obesity).\n\nThe goal of the PRESAFE trial is to investigate whether addition of a biomarker (presepsin) to the Dutch early-onset neonatal sepsis (EOS) guideline safely reduces unnecessary empirical antibiotic exposure after birth in preterm infants born before 32 weeks gestational age. In this 874-subject multicenter, randomized clinical trial with a concurrent observational cohort, the hypothesis to be tested is that by adding presepsin to the national guideline the amount of unnecessary empirical antibiotic exposure after birth will be reduced with at least 30% without increase in infants with untreated sepsis. The study targets a population of clinical stable very preterm infants with risk factors for eary-onset neonatal sepsis. Antibiotic administration after birth is started to pre-emptively treat EOS.\n\nBy adding a presepsin-guided step to the Dutch EOS guideline for those infants qualifying for antibiotic treatment, it is assumed that the rate of antibiotic administration can be reduced. However, it is imperative that this reduction in antibiotics is not outweighed by an increase in (culture proven) EOS. Therefore, the co-primary outcomes of the study are: 1) the incidence of culture-proven EOS (non-inferiority) and 2) unnecessary antibiotics prescription i.e. antibiotic administration for ≤ 3 days when started within the first 72 hours after birth (superiority). Secondary outcomes include sepsis-related severity of illness, total number of antibiotic days when started \\\u003C 72 hours after birth, and the composite outcome of necrotizing enterocolitis (NEC), late-onset sepsis (LOS), or death until discharge from the initial hospital.",[82],"Early-Onset Neonatal Sepsis",[84,85,86],"preterm infants","antibiotics","presepsin","2025-09-30",{"date":89,"type":90},"2025-10-02","ACTUAL",{"date":92,"type":90},"2024-09-23",{"date":94,"type":76},"2027-01-01",{"name":5,"class":6},1]