[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628339":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":57,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Neonates less than 35 weeks gestational age",null,[12],"Other: Standard of care administration of gentamicin dosed at 3 mg\u002Fkg every 24 hours",{"label":14,"type":10,"description":10,"interventionNames":15},"Neonates at least 35 weeks gestational age",[16],"Other: Standard of care administration of gentamicin dosed at 3.5 mg\u002Fkg every 24 hours",[18,22],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"Standard of care administration of gentamicin dosed at 3 mg\u002Fkg every 24 hours","No interventions will be made to the neonates. Standard of care will be followed with empiric gentamicin and levels ordered for the neonates at the discretion of the medical team.",[9],{"type":6,"name":23,"description":20,"armGroupLabels":24,"otherNames":10},"Standard of care administration of gentamicin dosed at 3.5 mg\u002Fkg every 24 hours",[14],[26],{"name":27,"affiliation":28,"role":29},"Venita Harris, PharmD","London Health Sciences Centre","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Sarah H.P. Vo, PharmD","CONTACT","519-685-8500","52162","sarah.vo@lhsc.on.ca",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Children's Hospital: London Health Sciences Centre","RECRUITING","London","Ontario","N6A 5W9","Canada","CA",{"type":47,"coordinates":48},"Point",[49,50],-81.23304,42.98339,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":34,"phoneExt":55,"email":56},"Venita Harris, BScPharm, PharmD","52642","venita.harris@lhsc.on.ca",{"type":29,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Venita Harris","Pharmacy Residency Specialist","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":71,"type":72},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.",[76],"Early Onset Sepsis",[78,79,80],"gentamicin","extended interval dosing","neonates","2026-06-05",{"date":83,"type":84},"2026-06-09","ACTUAL",{"date":86,"type":72},"2026-06",{"date":88,"type":72},"2027-04",{"name":5,"class":6},1]