[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-onset-sepsis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-onset-sepsis":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100628339","extended-interval-dosing-of-gentamicin-in-neonates-100628339",false,"NCT07460349","Extended Interval Dosing of Gentamicin in Neonates","Extended Interval Dosing of Gentamicin in Neonates to Achieve Target Drug Concentrations","Inclusion Criteria:\n\n* Neonates up to 7 days of age,\n* Neonate must be on gentamicin, and\n* Gentamicin trough and peak levels must be available for the third dose of gentamicin.\n\nExclusion Criteria:\n\n* Incorrect dose for weight (+\u002F- 10% allowed to account for dose rounding)\n* Multiple levels from the same patient; only the first set of levels will be collected\n* Baseline renal dysfunction (e.g. congenital kidney disease)\n* On other nephrotoxic or ototoxic drugs concurrently with the first 3 days of gentamicin","ALL","0 Days","7 Days",{"count":20,"type":21},42,"ESTIMATED","OBSERVATIONAL","A previous pharmacy residency project was done 20 years ago looking at the best dosing for the antibiotic gentamicin for babies up to 7 days old. This study showed that giving the dose less often leads to better drug concentrations than giving the dose more often. Our gentamicin dosing at the Children's Hospital at London Health Sciences Centre is based on the better dosing from the study. This dosing is gentamicin 3 mg\u002Fkg every 24 hours for babies less than 35 weeks gestational age and 3.5 mg\u002Fkg every 24 hours for babies at least 35 weeks gestational age. These results were never published. Different dosing is used at different hospitals. It is important that we check that our gentamicin dosing is still reaching safe and effective drug concentrations in the current study. The study will look at the gentamicin drug concentrations of babies up to 7 days old, including premature and term babies. We will also confirm if the babies have kidney or hearing damage from gentamicin. We will compare the gentamicin drug concentrations from this study to the past data to see if the dosing is still the best. The results can help form a guideline for the Children's Hospital and surrounding hospitals.",[25],"Early Onset Sepsis",[27,28,29],"gentamicin","extended interval dosing","neonates","RECRUITING","2026-06-05",{"date":33,"type":34},"2026-06-09","ACTUAL",{"date":36,"type":21},"2026-06",{"date":38,"type":21},"2027-04",{"name":40,"class":41},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":42},"100640398","phase-1-optimizing-preterm-infant-ampicillin-dosing-100640398","NCT07610486","Optimizing PreTerm Infant Ampicillin Dosing","An Open-label, Pharmacokinetic and Safety Trial Optimizing PreTerm Infant Ampicillin Dosing","OPTI-Amp","Inclusion Criteria:\n\n* Documented informed consent from parent\u002Fguardian\n* Infants admitted to the Duke Neonatal Intensive Care Unit (NICU)\n* less than or equal to 34 completed weeks gestational age (GA) at birth and \\\u003C 7 days of life at time of screening\n* Prescribed ampicillin by provider per standard of care for evaluation of early onset sepsis\n\nExclusion Criteria:\n\n* Infant on extracorporeal support (e.g., ECMO)\n* Positive blood culture or other confirmed infection\n* At time of consent, infants with GA \\\u003C28 completed weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28 to 34 completed weeks who have received \\> 32 to 36 hours of ampicillin, depending on dosing regimen\n* Has major congenital abnormalities where survival to 30 days of life is not expected\n* Failure to obtain consent from parent\u002Fguardian\n* Receives a course of ampicillin that is longer (i.e., more doses) than the short-course defined regimen for their GA\n* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",{"count":52,"type":21},60,"INTERVENTIONAL",[55,56],"PHASE1","PHASE2","The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safety receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours). The main questions it aims to answer are:\n\n* Does short-course ampicillin provide high enough levels of ampicillin at 48 hours?\n* Is short-course ampicillin safe for preterm infants to receive?\n\nPreterm infants who are being prescribed ampicillin by their doctor and enroll in the study will stop ampicillin after a shorter than typical course, and researchers will collect blood samples to measure their ampicillin levels and follow them clinically to see how they do after receiving short-course ampicillin.\n\nParticipants will:\n\n* stop ampicillin earlier than 48 hours (between 24 to 36 hours, depending on how premature they are and the dosing of ampicillin their doctor has prescribed)\n* have a blood sample collected around 48 hours from when they started ampicillin\n* have their data collected until 30 days after they receive short-course ampicillin, or until hospital discharge, whichever is sooner",[25,59,60,61,62],"Preterm Neonates","NICU","Ampicillin","Safety and Pharmacokinetics","NOT_YET_RECRUITING","2026-05-21",{"date":66,"type":34},"2026-05-28",{"date":68,"type":21},"2026-07",{"date":70,"type":21},"2027-12",{"name":72,"class":41},"Duke University",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100581055","promoting-optimal-treatment-choices-in-neonates-with-suspected-early-onset-sepsis-100581055","NCT06845332","Promoting Optimal Treatment Choices in Neonates With Suspected Early-Onset Sepsis","PROTeCt-NEO: Promoting Optimal Treatment Choices Through Implementation of Antibiotic Stewardship Strategies in Neonates With Suspected Early-Onset Sepsis","PrOTeCt-NEO","Inclusion Criteria:\n\n* Neonates born at 34 weeks of gestation or later\n* 0-3 days old\n\nExclusion Criteria:\n\n* stillborn neonates","3 Days",{"count":83,"type":21},55000,"In this study, three neonatal evidence-based antibiotic stewardship strategies will be implemented in Dutch hospitals. These include the early-onset sepsis (EOS) calculator, procalcitonin (PCT)-guided therapy, and IV-to-oral switch therapy. These strategies have been proven to be effective and safe and are already applied in several Dutch hospitals. However, this is not the case for all hospitals, leading to significant variations in clinical practice. To facilitate the translation of evidence into practice, active implementation will take place.\n\nThe primary research design is a prospective implementation study, using a multicenter, non-randomized pre-post design. The aim is to assess the impact of implementing a bundle of antibiotic stewardship interventions (including the EOS calculator, PCT-guided therapy and iv-to-oral switch therapy) in Dutch hospitals, using a multicomponent implementation strategy, on both clinical and implementation outcomes, with a particular focus on evaluating the employed implementation strategies.\n\nA combination of qualitative and quantitative research methods will be used to assess outcomes. Quantitative clinical data from neonates in the pre- and post-implementation periods will be retrospectively collected by the Business Intelligence units of participating hospitals and anonymized before being provided to the central research team. Qualitative data will be gathered through focus groups, interviews, and surveys.",[86],"Early-onset Sepsis",[88,89,90,91,92,93],"early-onset sepsis","neonatal sepsis","early-onset sepsis calculator","PCT-guided therapy","iv-to-oral switch therapy","implementation","2025-09-18",{"date":96,"type":34},"2025-09-19",{"date":98,"type":34},"2024-01-01",{"date":100,"type":21},"2026-06-01",{"name":102,"class":41},"Franciscus Gasthuis",11]