[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100154765":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":23,"interventions":23,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":61,"collaborators":23,"id":63,"slug":23,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":23,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":23,"studyType":74,"phases":23,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":43,"whyStopped":23,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":23},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Area under the curve (AUC)","actual body exposure to drug after a dose of the drug is administered. this is dependent on on the rate of drug elimination divided by plasma concentration of the drug.","approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication.",{"measure":14,"description":15,"timeFrame":16},"Volume of distribution at steady-state","Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.","approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.",{"measure":18,"description":19,"timeFrame":16},"Terminal elimination rate constant (Ke) and Half-Life","Period of time that it takes for the concentration of the drug in the body to be reduced by on-half.",{"measure":21,"description":22,"timeFrame":16},"Plasma Clearance","the rate at which the drug is eliminated from the body divided by the plasma concentration.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"CASE_ONLY","PROSPECTIVE","There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood\u002Fbody fluid samples from a test done as part of the standard of care.","children \\\u003C 8 years of age currently receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care",[30],{"name":31,"affiliation":32,"role":33},"Matthew M. Laughon, MD, MPH","University of North Carolina","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":23,"email":39},"Sneha Makhijani, BS","CONTACT","(984) 974-7865","sneha_makhijani@med.unc.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of North Carolina NC Children's Hospital","RECRUITING","Chapel Hill","North Carolina","27514","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-79.05584,35.9132,{"lat":53,"lon":52},[56,59],{"name":57,"role":37,"phone":58,"phoneExt":23,"email":39},"Sneha Makhijani, MS, RN","984-974-7865",{"name":60,"role":33,"phone":23,"phoneExt":23,"email":23},"Matthew M Laughon, MD, MPH",{"type":62,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100154765",false,"NCT01286519","Pharmacokinetics of Off Label Pediatric Medications","Inclusion Criteria:\n\n* Children less than 8 years of age\n* Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care\n\nExclusion Criteria:\n\n* Lack of consent","ALL","1 Day","8 Years",{"count":72,"type":73},400,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.",[77],"Off Label Use of Medications in Pediatric Patients",[79],"pharmacokinetics","2026-06-29",{"date":82,"type":83},"2026-07-01","ACTUAL",{"date":85,"type":83},"2010-07",{"date":87,"type":73},"2035-12",{"name":5,"class":6},1]