Background Neonatal vancomycin target trough levels are not always achieved, increasing the risk of morbidity and mortality due to treatment failure. The British National Formulary for Children (BNFc) dosing guidance, for which there is no published review of its target level achievement, is used widely. In 2007, the BNFc changed its target recommendations from 5–10 mg/L to 10–15 mg/L, due to increased rates of resistance, but did not change its dosage recommendations. Potentially neonates are being under-dosed post 2007. Purpose To determine the current trough level achievement for neonatal vancomycin (based on BNFc dosing) and then, by using pharmacokinetic modelling, provide recommendations for an improved dosing regimen. Materials and methods Retrospective data was used, of all neonates with a vancomycin level analysed between 1 January 2009 and 30 June 2012, from NHS Tayside, Scotland. Medical notes for each patient were reviewed to obtain the gestational and postnatal ages, birth and dosing weights, initial vancomycin dose and level, and serum creatinine. An audit determined target trough achievement. Various published pharmacokinetic population models were evaluated for predicting vancomycin levels in the Tayside sample. The association between prediction errors and clinical characteristics was analysed using multiple regression to assist in formulating a new dosing regimen to improve target achievement. Results Only 13.3% of initial vancomycin levels lay within the target range of 10–15 mg/L in the Tayside sample (n = 83). Evaluation of published pharmacokinetic models found that the model based on serum creatinine (Grimsley and Thomson, 1999) most accurately predicted vancomycin levels for the Tayside sample with an average 51.16% unsigned percentage prediction error. Serum creatinine was the only clinical characteristic significantly (p < 0.05) related to the model’s prediction error. Conclusions Modifying the Grimsley and Thomson (1999) model to account for the systematic bias found enabled a new dosing strategy to be developed based on serum creatinine. This new dosing strategy needs to be prospectively audited to measure potential improvements in target levels. Reference Grimsley C, Thomson A. Pharmacokinetics and dose requirements of vancomycin in neonates. Archives of Disease in Childhood – Fetal and Neonatal Edition, 1999;81:pp. F221-F227 No conflict of interest.
Results: There were differences in DR management with level III units using significantly more ventilation devices with PEEP (95% vs 88%, P< 0.05) and delivery room CPAP (43% vs 16%, P< 0.0001). Significantly more level III units commenced resuscitation in air (49% vs 30%, P=0.01) and fewer used 100% oxygen (12% vs 40%, P< 0.0001). The use of pulse oximeters (III=23% vs II/I=12%), plastic wraps/bags (III=97% vs II/I=96%), DR surfactant (III=92% vs II/I=83%) and elective intubation of preterm infants (III=83% vs II/I=73%) were not statistically different. Conclusions:These important data highlight significant variance of DR management for newborn infants in the UK with level III units adopting a more evidence-based practice. Furthermore, these data differ markedly from those reported in other developed countries. These discrepancies between resuscitation guidelines, DR management and poor evidence-base need urgent attention. Results: 60 live newborns with CDH were identified. Median gestational age at birth was 39 weeks (range 33-42 weeks). The median birth weight was 2970g (range 1080-4090g). There were 35 boys (58%). 53 cases were left sided. 3 babies died in delivery suite despite active resuscitation. 18 babies died on the neonatal unit despite full intensive care. 6 were referred for ECMO(5 of these survived). 33 babies were transferred to PICU but 3 babies died before surgery (1 unknown). 29 babies had surgery and 2 died post-surgery. The 30 day surgical survival rate was 93%. 32 babies are alive to date (1 unknown). Conclusion:In our experience, 35% of babies died in the immediate neonatal period. Transfer for ECMO has been a recent practice with 83% survival. 30 day surgical survival was 93%. However, the overall survival of a live born baby with CDH was 53%. Therefore, when counselling parents in the antenatal period, it is important to quote all figures rather than surgical survival alone.[1] Robinson PD, Fitzgerald DA. Congenital diaphragmatic hernia. Paediatric Respiratory Reviews
Traditional or “off the shelf” or “out of box” method of acquisition of medical devices and technology is currently being challenged by clinical users. As hardware, connectivity, and Health information systems (HISs) are becoming the key enablers of delivery of integrated patient monitoring; there is an increasing requirement for a coproductive approach to the choice and implementation of patient monitoring systems. The complexity of the clinical environment requires a collaboration of many stakeholders with a common focus and shared goals to ensure the correct choices and outcomes are delivered to satisfy requirements of clinical users and the wider system. Implementation of change through operationalization of such technologies is, however, complicated by regulation, accreditation, and standards requirements. In response to these and other issues, clinical engineers are recommending that the safest, efficient, and most effective approach to introduction of new systems is to conduct a test of change prior to major acquisitions of medical devices and systems that carry organization-wide clinical impact. The proposed approach is consistent with the Plan-Do-Study-Act cycle improvement model. In this case study, neonatal intensive care unit was used to assess the introduction of an “integrated patient monitoring system” into NHS Tayside.
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