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Urine bags are commonly used to collect urine samples from neonates. However, the sample can be contaminated by stool, or detachment of the bag due to body movement can lead to failure of the collection. A qualitative urine collection kit containing ten filter papers of 3.2 mm diameter was developed and clinically verified among 138 neonates. During a single diaper change (approximately 3 h), the rate of urine collection was calculated. Urine collection was considered to be successful if any filter paper in the urine collection sheet turned from blue to white. Of the 127 neonates who passed urine, 122 had a change in the filter paper. The urine collection rate was 96%, with changes in all 10 filter papers observed in 98 neonates (80%). Urine collection rate was not influenced by sex (p = 1.00), age at collection (p = 0.72), preterm birth (p = 1.00), low birth weight (p = 0.92), or fecal contamination (p = 1.00). The incidence of dermatitis was not higher than in the group in which urine bags were used (urine collection kit: 2/68 [3%]; urine bag: 5/68 [7%]; p = 0.44). Novel urine collection kits using filter paper can collect samples from neonates safely and with a high probability of success.

Background Bacterial infections and some antibiotics show displacer effects on bilirubin-albumin binding and increase unbound bilirubin (UB) but not total bilirubin (TB) in serum. Methods A case study was conducted to show a successful treatment of hyperbilirubinemia by monitoring UB. Results In an extremely preterm infant with bloodstream bacterial infection caused by methicillin-resistant coagulase-negative staphylococci, 2 days after high-dose ampicillin and regular-dose amikacin were initiated, UB markedly increased, but TB did not. After vancomycin was substituted, UB decreased immediately with phototherapy and intravenous albumin infusion. Conclusions When using antibiotics, the clinicians should be mindful regarding the displacer effect on bilirubin-albumin binding.

To date, no clinical studies have compared the accuracy of serum procalcitonin (PCT) reference curves. We aimed to validate the diagnostic accuracy of previously reported serum PCT reference curves and to determine which biomarkers among a cut-off value over the 95th percentile in the serum PCT reference curve, white blood cell (WBC) count, and C-reactive protein (CRP) and immunoglobulin M (IgM) levels, have the highest diagnostic accuracy for early-onset neonatal bacterial infections. This retrospective cohort study assessed 16 preterm and 23 term infants with suspected bacterial infections within 72 h after birth. Each infant group was divided into two subgroups: confirmed- and non-infection. The diagnostic accuracy was determined using the Youden index. The reference curves by Fukuzumi et al. in preterm and term infants had the highest Youden indexes: 1.000 and 0.324, respectively. Among preterm infants, the Youden index for PCT was 1.000. Among term infants, the Youden index for a combination of PCT, CRP, and WBC and/or IgM was 1.000. In conclusion, a serum PCT level over the 95th percentile on the reference curve for preterm infants and a combination of PCT and CRP levels with WBC count and/or IgM levels for term infants provided sufficient diagnostic accuracy.

Drug agencies and pharmaceutical companies are responsible for continuously monitoring drug safety profiles to implement necessary safety measures. Retrospective analyses of safety-related regulatory actions (SRRAs) are known to be helpful as a tool for evaluating postmarketing safety in Western countries. However, few studies have examined the relationship between SRRAs and postmarketing safety in Japan. The aim of this study was to evaluate postmarketing safety risk by examining cases of adverse drug reactions appended to the clinically significant adverse reactions (CSARs) section in package inserts as a marker of Japanese SRRAs. We identified new molecular entities (NMEs) approved in Japan between 1 January 1999 and 31 December 2010, and classified them into two groups: NMEs already approved overseas (Overseas group) and NMEs initially or only approved in Japan (Japan group). Each NME included in this study was investigated for CSARs appended into the package insert based on the ‘Revision of Precautions Section of Package Insert’ released by the end of 2011. The potential of exposure to unknown postmarketing safety risk was expressed as the incidence rate of appended CSARs. In addition, the Kaplan-Meier method was used for analysis of the time until the first CSAR was appended. Among 315 NMEs, we identified 943 appended CSARs that were mandated by the Pharmaceutical and Medical Devices Agency. The incidence rate of CSARs appended for all NMEs was 0.42/drug-year (95% confidence interval [CI] 0.40, 0.45) and individual incidence rates were 0.41/drug-year (95% CI 0.38, 0.44) in the Overseas group, and 0.48/drug-year (95% CI 0.42, 0.55) in the Japan group. In the Overseas group, when subgrouping drugs on the basis of the length of each drug lag, incidence rates of CSARs tended to be greater for shorter drug lags. Using the Overseas group as a reference, the incidence rate ratio (IRR) in the Japan group was evaluated as 1.17 (95% CI 1.01, 1.36). Standardized IRRs for each background factor and the lower limit of the 95% CIs were greater than 1. CSARs were most frequently appended 2 and 3 years after the approval of the NME. Furthermore, CSARs were likely to be appended earlier for NMEs initially or only approved in Japan. The present results suggest that appended CSARs can offer a useful indicator of Japanese SRRAs. Furthermore, NMEs with little or no foreign safety information are more likely to have unknown safety risks recognized more frequently at an early stage of postmarketing. Although this study focused on Japan, unknown risk generally increases with the elimination of drug lag, regardless of location. Reinforcement of a safety monitoring system is thus vital.

This paper presents a simplified analytical method for rectangular plates with arbitrarily and eccentrically stepped thickness, such as building slabs, under the validity of the Kirchhoff-Love hypotheses. The discontinuous variation in bending stiffness due to the variation of the thickness can be expressed continuously by the use of an extended Heaviside function, which is defined as a Dirac function existing continuously in a prescribed region. Since the bending stiffness used here is given exactly by the actual bending stiffness at each point, a modification of the bending stiffness used in an equivalent plate analogy is unnecessary. The governing equations are formulated by means of Hamilton’s principle. Static and dynamic approximate but accurate solutions are obtained from the proposed governing equation by the use of the Galerkin method. The numerical results obtained from the proposed theory for simply supported and clamped plates with stepped thickness show good agreement with results obtained from the finite element method using the code NASTRAN.