NOMOGRAM FOR GENTAMICIN DOSING IN EARLY INFANCY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 庆大霉素是婴儿的常规用药，既可用于早期和晚期败血症的经验性治疗，也可用于治疗革兰氏阴性菌血症。由于庆大霉素的治疗指数很窄，因此需要进行治疗药物监测。新生儿的药代动力学数据表明，庆大霉素每日一次给药(ODD)方案会导致峰值和低谷浓度在治疗和无毒范围内。这种庆大霉素剂量方案是帕克兰卫生和医院系统(PHHS)正常新生儿保育室(NNN)和新生儿重症监护病房(NNICU)的标准护理方案。为了使需要超过48小时治疗的婴儿达到治疗和无毒的水平，需要测量庆大霉素的峰浓度和谷浓度。最近，庆大霉素的奇数也扩展到了NNICU中的早产儿(妊娠34周)。我们最近为足月儿和近月儿开发了庆大霉素给药的诺模图或药代动力学模型，该模型可能允许确定单一随机水平的Getamicin，以评估治疗剂量和无毒剂量。然而，在推荐将其常规使用作为峰值和低谷浓度测量的替代之前，该诺模图需要进一步的临床测试。 在妊娠34周的早产儿中，不存在允许较少抽血来测量庆大霉素浓度的诺模图。因此，这项前瞻性研究有两个重要的目标：1.建立早产儿庆大霉素每日一次给药的标准图(研究1)；2.评估我们先前开发的庆大霉素在足月和近月儿中每天给药一次的标准图(研究2)。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for 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).