NOMOGRAM FOR GENTAMICIN DOSING IN EARLY INFANCY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 庆大霉素通常用于婴儿早期和晚期败血症的经验性治疗以及革兰氏阴性菌血症的治疗。 由于庆大霉素的治疗指数较窄，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）方案导致峰浓度和谷浓度在治疗和无毒范围内。 该庆大霉素给药方案是帕克兰健康和医院系统（PHHS）正常新生儿保育室（NNN）和新生儿重症监护室（NNICU）的标准治疗方案。测量庆大霉素的峰浓度和谷浓度，以使需要超过48小时治疗的婴儿达到治疗和无毒水平。 最近，庆大霉素的ODD也已扩展到NNICU的早产新生儿（<34周妊娠）。 我们最近开发了一个诺模图或庆大霉素给药的足月和近足月婴儿的药代动力学模型，可能允许确定一个单一的随机水平的getamicin的治疗和无毒剂量的评估。 然而，在推荐将其常规使用作为峰和谷浓度测量的替代品之前，该列线图需要进一步的临床试验。 在妊娠<34周的早产儿中，不存在这样的列线图，其将允许较少的用于测量庆大霉素浓度的血液抽取。 因此，本前瞻性研究有两个重要目的：1。开发早产新生儿庆大霉素每日一次给药的列线图（研究#1）;和2.评价我们先前在接受每日一次庆大霉素给药的足月和近足月婴儿中开发的庆大霉素列线图（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).