This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Gentamicin is used routinely in infants both for empiric treatment of early and late onset sepsis and in the treatment of gram-negative bacteremia. Therapeutic drug monitoring is needed since gentamicin has a narrow therapeutic index. Pharmacokinetic data in neonates have shown that once daily dosing (ODD) regimen for gentamicin results in peak and trough concentrations that are within the therapeutic and nontoxic range. This regimen for gentamicin dosing is the standard of care in the Normal Newborn Nursery (NNN) and Neonatal Intensive Care Unit (NNICU) at Parkland Health and Hospital System (PHHS). Peak and trough concentrations of gentamicin are measured in order to achieve therapeutic and nontoxic levels for infants requiring more than 48 hours of treatment. Recently, ODD for gentamicin has been extended to preterm newborns (<34 weeks gestation) in the NNICU as well. We recently developed a nomogram or a pharmacokinetic model for gentamicin administration for term and near term infants that potentially allows for the determination of a single random level of getamicin for the assessment of a therapeutic and nontoxic dose. This nomogram, however, requires further clinical testing before its routine use can be recommended as a replacement for the measurement of peak and trough concentrations.In preterm infants <34 weeks of gestation, no such nomogram exists that will allow less blood draws for measurement of gentamicin concentrations. Accordingly, this prospective study has two significant aims: 1. to develop a nomogram for once daily dosing of gentamicin in preterm neonates (Study #1); and 2. to evaluate our previously developed gentamicin nomogram in full- and near term infants who are receiving once daily dosing of gentamicin (Study #2).
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