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Data were described using non\u2010linear mixed\u2010effects regression analysis ( <jats:sc>nonmem<\/jats:sc>\u00ae).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 3039 gentamicin concentrations collected in 994 preterm and 455 term newborns were included in the analysis. A two compartment model best characterized gentamicin disposition. The average parameter estimates, for a median body weight of 2170\u2009g, were clearance (<jats:styled-content style=\"fixed-case\">CL<\/jats:styled-content>) 0.089\u2009l\u2009h<jats:sup>\u22121<\/jats:sup> (<jats:styled-content style=\"fixed-case\">CV<\/jats:styled-content> 28%), central volume of distribution (<jats:italic><jats:styled-content style=\"fixed-case\">V<\/jats:styled-content><\/jats:italic><jats:sub>c<\/jats:sub>) 0.908\u2009l (<jats:styled-content style=\"fixed-case\">CV<\/jats:styled-content> 18%), intercompartmental clearance (<jats:styled-content style=\"fixed-case\">Q<\/jats:styled-content>) 0.157\u2009l\u2009h<jats:sup>\u22121<\/jats:sup> and peripheral volume of distribution (<jats:italic><jats:styled-content style=\"fixed-case\">V<\/jats:styled-content><\/jats:italic><jats:sub>p<\/jats:sub>) 0.560\u2009l. Body weight, gestational age and post\u2010natal age positively influenced <jats:styled-content style=\"fixed-case\">CL<\/jats:styled-content>. Dopamine co\u2010administration had a significant negative effect on <jats:styled-content style=\"fixed-case\">CL<\/jats:styled-content>, whereas the influence of indomethacin and furosemide was not significant. Both body weight and gestational age significantly influenced <jats:italic><jats:styled-content style=\"fixed-case\">V<\/jats:styled-content><\/jats:italic><jats:sub>c<\/jats:sub>. Model\u2010based simulations confirmed that, compared with term neonates, preterm infants need higher doses, superior to 4\u2009mg\u2009kg<jats:sup>\u22121<\/jats:sup>, at extended intervals to achieve adequate concentrations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This observational study conducted in a large cohort of newborns confirms the importance of body weight and gestational age for dosage adjustment. The model will serve to set up dosing recommendations and elaborate a Bayesian tool for dosage individualization based on concentration monitoring.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.12444","type":"journal-article","created":{"date-parts":[[2014,6,17]],"date-time":"2014-06-17T13:46:32Z","timestamp":1403012792000},"page":"1090-1101","source":"Crossref","is-referenced-by-count":63,"title":["Population pharmacokinetic study of gentamicin in a large cohort of premature and term neonates"],"prefix":"10.1111","volume":"78","author":[{"given":"Aline","family":"Fuchs","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology Service of Biomedicine, Department of Laboratory Centre Hospitalier Universitaire Vaudois and University of Lausanne  Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monia","family":"Guidi","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology Service of Biomedicine, Department of Laboratory Centre Hospitalier Universitaire Vaudois and University of Lausanne  Lausanne Switzerland"},{"name":"School of Pharmaceutical Sciences University of Geneva, University of Lausanne  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Giannoni","sequence":"additional","affiliation":[{"name":"Service of Neonatology Department of Paediatrics Centre Hospitalier Universitaire Vaudois and University of Lausanne  Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique","family":"Werner","sequence":"additional","affiliation":[{"name":"Clinical Chemistry Laboratory Service of Biomedicine Centre Hospitalier Universitaire Vaudois and University of Lausanne  Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierry","family":"Buclin","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology Service of Biomedicine, Department of Laboratory Centre Hospitalier Universitaire Vaudois and University of Lausanne  Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Widmer","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology Service of Biomedicine, Department of Laboratory Centre Hospitalier Universitaire Vaudois and University of Lausanne  Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chantal","family":"Csajka","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology Service of Biomedicine, Department of Laboratory Centre Hospitalier Universitaire Vaudois and University of Lausanne  Lausanne Switzerland"},{"name":"School of Pharmaceutical Sciences University of Geneva, University of Lausanne  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,10,20]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2010.337"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/124.Supplement_1.S145"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/124.Supplement_1.S148"},{"issue":"241","key":"e_1_2_10_5_1","first-page":"54","article-title":"Retrospective study of the ototoxicity of gentamicin","author":"Banck G","year":"1973","journal-title":"Acta Pathol Microbiol Scand B Microbiol Immunol"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1159\/000244391"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2012-0541"},{"key":"e_1_2_10_8_1","first-page":"w13873","article-title":"Taskforce for the Swiss Society of N, the Paediatric Infectious Disease Group of S. 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