[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-onset-neonatal-sepsis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-onset-neonatal-sepsis":104},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":19,"type":20},900,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Early-Onset Neonatal Sepsis",[28,29,30],"preterm infants","antibiotics","presepsin","RECRUITING","2025-09-30",{"date":34,"type":35},"2025-10-02","ACTUAL",{"date":37,"type":35},"2024-09-23",{"date":39,"type":20},"2027-01-01",{"name":41,"class":42},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":43},"100545092","phase-3-selective-antibiotics-when-symptoms-develop-versus-universal-antibiotics-for-preterm-neonates-100545092","NCT06377397","Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates","Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates At-risk of Early-onset Bacterial Sepsis: a Multicentric, Randomized, Controlled, Non-inferiority Trial (the SAUNA Trial)","SAUNA","Inclusion criteria:\n\n* Gestational age of 26 to 34 weeks\n* Chronological age 4 hours\n* Have any one or both of the following risk factors of EONS:\n\n  * Prolonged rupture of membranes \\>18 hours\n  * Pre-labour rupture of membranes \\[as all subjects will be preterm, this is effectively pPROM\\]\n* Are either asymptomatic or have no signs attributable to sepsis at 4 hours. This will be defined as absence of the following clinical signs or need for interventions mentioned below:\n\n  1. Apnea (Standard definition) requiring intervention at any time until enrolment.\n  2. Need for a fluid bolus or inotropic support at any time until enrolment.\n  3. Seizures or seizure-like activity at any time until enrolment.\n  4. Upper GI bleed in the absence of a history of ante-partum hemorrhage at any time until enrolment.\n  5. Pus from any site at any time until enrolment.\n  6. Need for CPAP \\>6 cms of water with FiO2 \\>35% at 6-8 hours OR need for CPAP £6 cms and FiO2 £35% but with increasing requirement of support\\*\\*\n  7. Chest Xray (if performed) with radiological features of pneumonia.\n  8. Need for intubation and mechanical ventilation.\n  9. Temperature \\>37.5°C or \\\u003C36°C, unexplained by environmental causes\n  10. Feed intolerance \\[bilious or bloodstained vomiting (or gastric residuals) or visibly distended abdomen or \\>50% of the previous feed volume as gastric residuals\\]\n  11. Lethargy or unarousability\n  12. Sclerema\n\n      Exclusion Criteria:\n\n      Subjects will be excluded if they have any 1 of the following:\n\n  \u003C!-- -->\n\n  1. Life-threatening congenital malformation\n  2. Severe perinatal asphyxia (Apgar score \\\u003C5 at 10 minutes or cord pH \\\u003C7.0)\n  3. Clinical chorioamnionitis# \\[see definition below\\]\n  4. Foul-smelling liquor\n  5. Multiple gestation\n  6. Received a dose of antibiotics\n  7. Positive amniotic fluid culture (if performed and available prior to randomization)\n  8. Treating neonatologist unwilling to enroll the patient in the trial on the grounds that the patient needs antibiotics.\n\n     \\-","0 Hours","4 Hours",{"count":55,"type":20},1500,[57],"PHASE3","Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis.\n\nThe goal of this research study is to find out:\n\n1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life.\n2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life.\n3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under \"Outcomes\").",[60,61,26,62,63],"Sepsis","PROM, Preterm (Pregnancy)","Preterm Premature Rupture of Membrane","Preterm Birth",[65,66,67,68,69],"Prolonged rupture of membranes","Preterm premature rupture of membranes","Early-onset neonatal sepsis","Selective antibiotics","Non-inferiority trial","NOT_YET_RECRUITING","2024-04-17",{"date":73,"type":35},"2024-04-22",{"date":75,"type":20},"2024-04-15",{"date":77,"type":20},"2028-04-14",{"name":79,"class":80},"Indian Council of Medical Research","OTHER_GOV",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":88,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":43},"100521946","population-pharmacokinetic-of-piperacillintazobactam-in-maternal-and-neonatal-populations-100521946","NCT06076200","Population Pharmacokinetic of Piperacillin\u002FTazobactam in Maternal and Neonatal Populations","Population Pharmacokinetic of Piperacillin\u002FTazobactam in Maternal and Neonatal Populations With High Risk for EOS","Inclusion Criteria:\n\n* Patients over 18 years old;\n* Pregnant women whose baby are at high risk of developing early-onset sepsis after birth have indications to use preventive or therapeutic antibiotics, and the antibiotics used are PIP\u002FTAZO；\n* Patients and their families are fully aware of the research content and sign the informed consent form.\n\nExclusion Criteria:\n\n* Intolerance or serious adverse reactions to antibiotic use;\n* Patients who stopped using PIP\u002FTAZO more than 24 hours before delivery;\n* Receiving other systemic trial drugs;\n* There are other factors that the researchers think are not suitable for inclusion","FEMALE","18 Years",{"count":91,"type":20},50,"OBSERVATIONAL","The purpose of this study is to describe the population pharmacokinetic characteristics of piperacillin\u002Ftazobactam after intravenous administration in pregnant women during pregnancy and delivery, and to evaluate pharmacodynamic effectiveness and safety of piperacillin\u002Ftazobactam in pregnant women whose baby are at high risk of developing early-onset sepsis after birth.",[26],"2023-10-07",{"date":97,"type":35},"2023-10-10",{"date":99,"type":20},"2023-09-30",{"date":101,"type":20},"2026-12-31",{"name":103,"class":42},"Shandong University","Early Onset Neonatal Sepsis"]