Influence of restricted mastication on swallowing function.

BACKGROUND: Oral food processing is an important part of daily food intake. A major part of this process is mastication, which prepares a bolus of food for swallowing by mechanically crushing and grinding ingested food between the teeth using rhythmic movements. Masticatory dysfunction is common in the elderly and in some neurological disorders and can have serious negative health consequences. OBJECTIVE: This study investigated the effect of restricted mastication, achieved by experimentally reducing the duration of mastication, on masticatory patterns and subsequent swallowing function. METHODS: Thirty healthy men (25 ± 3 years old) were instructed to chew gum jelly with a free mastication duration (G100), a half and a quarter duration of G100. Masseter and digastric electromyographic (EMG) activity was recorded to assess mastication and swallowing activity, respectively. In addition, the acceleration of the thyroid cartilage ridge was measured with an accelerometer. The root mean square (RMS) of muscle EMG activity in the masseter and digastric muscles, the number of masseter EMG bursts, time to peak and total duration of each masseter EMG burst, swallowing duration and laryngeal elevation latency were analysed. RESULTS: Restricting masticatory duration reduced the number of mastication cycles (p < .001), prolonged the time to peak (p < .001) and total duration of masseter EMG bursts (p < .001) and resulted in an overall increased RMS score of masseter muscle activity (p = .017). Furthermore, restricted masticatory duration led to a decrease in both swallowing duration (p = .001) and laryngeal elevation latency (p = .012), with a significant increase in the RMS score of digastric muscle activity (p < .001). CONCLUSIONS: Under the experimental conditions of restricted mastication, several adaptation features were observed, including changes in masticatory cycle characteristics and swallowing duration. Thus, although the overall masticatory efficiency was reduced, these adaptations allowed healthy individuals to still swallow safely.

Shock absorption and dispersion capability of a novel five-layer mouthguard sheet material.

There is a growing need for a mouthguard sheet material with higher shock absorption and dispersion capacity than those obtained by conventional materials. A five-layer mouthguard sheet material was previously developed using laminated ethylene vinyl acetate and polyolefin copolymer resin. In this study, the shock absorption capacity and dispersion capability of the new sheet material were investigated and compared with those of other materials. Impact testing for the new sheet material showed that the force required to displace the sheet by 1 mm was significantly higher at all thicknesses (p<0.001), whereas the puncture energy and displacement were significantly lower than those for ethylene vinyl acetate (p<0.05). The five-layer mouthguard sheet material successfully absorbed and resisted shock. Therefore, the sheet material potentially increases resistance to applied deformation in teeth and alveolar bone and maintains structure. The five-layer sheet material could expand the range of mouthguard products and help prevent oral trauma.

Comparison of masticatory muscle activity between young adults and elderly participants using a novel standardized bite device.

OBJECTIVES: Standardized bite training is required to prevent oral hypofunction in elderly individuals. We aimed to compare masticatory muscle activity between 24 young adults and 16 pre-elderly individuals during a biting task using a novel standardized bite device (BD). METHODS: The BD was made of silicone rubber and included a high-force or low-force plate spring or no plate spring (dummy). The compressive stiffness of the material in each BD was measured using a texture analyzer. All participants performed a biting task 50-times at a rate of 1/s each using the three types of BDs on the right first molar. Electromyographic (EMG) activity was recorded bilaterally from the masseter and temporalis muscles. The variability of each biting training session was calculated as the coefficient of variance (CV) from the EMG activity during each biting task for each muscle. Masticatory muscle fatigue was assessed using a numerical rating scale (NRS). RESULTS: Compressive stiffness was significantly different between each BD (P < 0.001). The CV and NRS scores were not significantly different between the groups. The EMG activities during each bite task in all muscles were not significantly different for any measurement item between the age groups. The EMG activities of high- and low-force BDs in the right temporalis (ipsilateral) muscle were significantly higher than those of the dummy BD (P < 0.001). CONCLUSIONS: Compressive stiffness of the BD affected EMG activity only in the ipsilateral temporalis muscle, but not in the masseter or contralateral temporalis muscles, without any age effect.

Summary Report of a Public Workshop: Case Studies of Multi-Regional Clinical Trial Incorporating Concept of the ICH E17 Guideline.

To further our understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guideline and promote effective implementation, a public workshop was held in Japan by regulatory agency and industry representatives. In this workshop, important concepts explained in the ICH E17 guideline, such as intrinsic/extrinsic ethnic factors that influence treatment effects ("effect modifiers") and the holistic evaluation of consistency of treatment effect were actively discussed through case studies. The importance of holistic evaluation of consistency was recognized, and it was concluded that the evaluation and relevant discussion should be shared with regulatory authorities, sponsors, and broader stakeholders.

Analysis of definite awake bruxism using a portable electromyography device.

PURPOSE: This study aimed to compare awake bruxism events between subjective and objective evaluations using a questionnaire survey and a modified portable electromyography (EMG) device, and to examine correlations between sleep quality and awake bruxism. METHODS: The Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), and awareness of awake bruxism as clarified via interviews were conducted on 34 participants as subjective evaluations. The EMG device was used to record left temporal muscle activity for 6.5 h (from 09:00 to 15:30) and the number of awake bruxism episodes per hour. The participants were then classified into "bruxer" and "non-bruxer" groups based on the number of awake bruxism episodes. RESULTS: The mean number of awake bruxism episodes per hour was 33.6 ± 21.4, and 23% of the participants who reported having no awareness of awake bruxism in the interviews were defined as "bruxers" in the objective evaluations. In the bruxer group, positive correlations were found between the number of awake bruxism episodes and both ESS and PSQI scores. CONCLUSION: These findings suggest that objective measurements using a portable EMG device can increase the diagnostic accuracy for awake bruxism, and that sleep quality is a major risk factor for awake bruxism.

Age differences in pain sensitivity and effect of topical lidocaine on the tongue in healthy female subjects.

PURPOSE: To assess the sensitivity and the effect of topical lidocaine on the tongue by quantitative sensory testing, comparing healthy middle-aged female subjects with healthy young female subjects. METHODS: Sixteen healthy female subjects including eight in their fifties and eight in their twenties participated. They participated in two sessions at a 2-week interval in randomized order: lidocaine (experimental session) or placebo gel (placebo session) was applied on the tongue tip for 5min. The following parameters were taken on the tongue tip before and after application of the gel in each session: tactile detection threshold (TDT), filament-prick pain detection threshold (FPT), and numerical rating scale (NRS). RESULTS: An increase of both TDT and FPT and a decrease of NRS were found after lidocaine application in both middle-aged and young female subjects. In the elder females, an increase of TDT, FPT, and NRS was also found after placebo gel application. However, the changes were not statistically significant, except for FPT in middle-aged subjects. CONCLUSION: The reactions found after lidocaine application in middle-aged female subjects could be due to habituation as well as to the post-application effect of placebo gel. Placebo-induced changes appeared more pronounced in the elder females.

Effect of clinical experience and training with visual feedback on standardized palpation outcomes-Potential implications for assessment of jaw muscle sensitivity.

BACKGROUND: The evaluation of muscle pain and sensitivity by manual palpation is an important part of the clinical examination in patients with myalgia. However, the effects of clinical experience and visual feedback on palpation of the masticatory muscles with or without a palpometer are not known. OBJECTIVE: To estimate the effects of clinical experience and visual feedback on the accuracy of palpation in standardized settings. METHODS: Thirty-two dentists (age 35 ± 11 years) classified as either specialists (n = 16) or generalists (n = 16) participated in this experiment. All dentists were instructed to target force levels of 500- or 1000-gf, as determined on an electronic scale using either standardized palpometers or manual palpation (MP). All dentists participated in four different tests: MP, MP with visual feedback (MPVF), palpometer (PAL) and PAL with visual feedback (PALVF). Actual force values for each type of palpation from 0 to 2, 2 to 5 and 0 to 5 s were analysed by calculating target force level. RESULTS: The relative differences during 2-5 and 0-5 s with 1000 gf were significantly lower for generalists than for specialists (p < .05). In generalists and specialists, the coefficients of variation and the relative differences during 2-5 s were significantly lower for PAL and PALVF than for MP (p < .05). CONCLUSIONS: These findings suggest that the use of a palpometer, but not clinical experience with palpation of masticatory muscles, increases the accuracy of palpation, and ≥2 s of palpation with a palpometer is optimal for masticatory muscles.

Diagnostic criteria for temporomandibular disorders-INfORM recommendations: Comprehensive and short-form adaptations for adolescents.

BACKGROUND: The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for use in adults is in use worldwide. Until now, no version of this instrument for use in adolescents has been proposed. OBJECTIVE: To present comprehensive and short-form adaptations of the adult version of DC/TMD that are appropriate for use with adolescents in clinical and research settings. METHODS: International experts in TMDs and experts in pain psychology participated in a Delphi process to identify ways of adapting the DC/TMD protocol for physical and psychosocial assessment of adolescents. RESULTS: The proposed adaptation defines adolescence as ages 10-19 years. Changes in the physical diagnosis (Axis I) include (i) adapting the language of the Demographics and the Symptom Questionnaires to be developmentally appropriate for adolescents, (ii) adding two general health questionnaires, one for the adolescent patient and one for their caregivers and (iii) replacing the TMD Pain Screener with the 3Q/TMD questionnaire. Changes in the psychosocial assessment (Axis II) include (i) adapting the language of the Graded Chronic Pain Scale to be developmentally appropriate for adolescents, (ii) adding anxiety and depression assessment that have been validated for adolescents and (iii) adding three constructs (stress, catastrophizing and sleep disorders) to assess psychosocial functioning in adolescents. CONCLUSION: The recommended DC/TMD, including Axis I and Axis II for adolescents, is appropriate to use in clinical and research settings. This adapted first version for adolescents includes changes in Axis I and Axis II requiring reliability and validity testing in international settings. Official translations of the comprehensive and short-form to different languages according to INfORM requirements will enable a worldwide dissemination and implementation.

Diagnostic criteria for temporomandibular disorders-INfORM recommendations: Comprehensive and short-form adaptations for children.

BACKGROUND: The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) are used worldwide in adults. Until now, no adaptation for use in children has been proposed. OBJECTIVE: The aim of this study was to present comprehensive and short-form adaptations of Axis I and Axis II of the DC/TMD for adults that are appropriate for use with children in clinical and research settings. METHODS: Global Delphi studies with experts in TMDs and in pain psychology identified ways of adapting the DC/TMD for children. RESULTS: The proposed adaptation is suitable for children aged 6-9 years. Proposed changes in Axis I include (i) adapting the language of the Demographics and the Symptom Questionnaires to be developmentally appropriate for children, (ii) adding a general health questionnaire for children and one for their parents, (iii) replacing the TMD Pain Screener with the 3Q/TMD questionnaire and (iv) modifying the clinical examination protocol. Proposed changes in Axis II include (i) for the Graded Chronic Pain Scale, to be developmentally appropriate for children, (ii) adding anxiety and depression assessments that have been validated in children and (iii) adding three constructs (stress, catastrophising and sleep disorders) to assess psychosocial functioning in children. CONCLUSION: The recommended DC/TMD, including Axis I and Axis II, for children aged 6-9 years, is appropriate for use in clinical and research settings. This adapted the first version for children includes changes in Axis I and Axis II changes requiring reliability and validity testing in international settings. Official translations to different languages according to INfORM requirements will enable a worldwide dissemination and implementation.

Mandibular Advancement Device Therapy in Japanese Rugby Athletes with Poor Sleep Quality and Obstructive Sleep Apnea.

Obstructive sleep apnea (OSA) may contribute to poor sleep quality. This study assessed subjective sleep quality, the Respiratory Event Index (REI), reaction times, and the therapeutic effects of a custom-made mandibular advancement device (MAD) in male Japanese elite rugby athletes. The Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and level III sleep test (REI and minimum oxygen saturation [SpO2 min]) were used to evaluate sleep quality. MAD therapy was used daily for 3 weeks. A telephone-based reaction time test of kinetic vision (the ability to identify moving objects) was recorded within 15 min of waking and over 5 days of pre- and post-MAD therapy. Differences in variables were evaluated using paired t-tests. Of the 42 players (mean age, 26.3 ± 3.7 years; mean body mass index, 28.7 ± 3.2 kg/m2) included in this study, 29 (69.0%) had poor sleep quality (PSQI > 5.5), and 27 were diagnosed with OSA (64.3%) (mild = 16/moderate = 9/severe = 2). Six were treated with MAD therapy, which significantly improved the REI (p < 0.01), SpO2 min (p < 0.001), ESS score (p < 0.001), reaction times (p < 0.01), and sleep quality. A significant reduction in reaction times suggests that OSA treatment can improve kinetic vision. Future studies should systematically evaluate the impact of sleep-disordered breathing on kinetic vision in athletes.

Improving Nasal Airflow with a Novel Nasal Breathing Stent.

Nasal obstruction requires close attention, as it is a risk factor for obstructive sleep apnea (OSA). This study evaluated airflow rates of our newly designed nasal breathing stent (NBS) compared with those of existing nasal dilators in 10 adult men. We hypothesized that the NBS would expand the nasal passage more than the other nasal dilators by means of airflow measurements. We compared airflow measurements between the NBS and three existing appliances and no appliance. Velocity measurements were recorded by analyzing 499 videographic images when each appliance was placed next to a steam generator at 0, 5, and 10 mm from the outlet port for airflow visualization. The peak nasal inspiratory flow (PNIF) rate was measured using an inspiratory flow meter. The NBS resulted in significantly higher airflow velocity measurements at all distances from the outlet port and a higher PNIF rate than the other appliances. Thus, the NBS offers a significantly decreased resistance to air movement compared with other appliances. Future in-depth investigations are required to demonstrate the use of NBS as a nasal dilator in conjunction with continuous positive airway pressure/oral appliance treatments in patients with OSA.

Diagnostic criteria for temporomandibular disorders in children and adolescents: An international Delphi study-Part 2-Development of Axis II.

BACKGROUND: Unlike the psychosocial assessment established for adults in the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), a standardised psychosocial assessment for children and adolescents with TMD complaints has not yet been established. OBJECTIVES: To develop a new standardised instrument set to assess the psychosocial functioning in children and adolescents by adapting the psychosocial status and pain-related disability (Axis II) of the adult DC/TMD and by including new instruments. METHODS: A modified Delphi method was used to survey 23 international TMD experts and four international experts in pain-related psychological factors for consensus regarding assessment tools for psychosocial functioning and pain-related disability in children and adolescents. The TMD experts reviewed 29 Axis II statements at round 1, 13 at round 2 and 2 at round 3. Agreement was set at 80% for first-round consensus level and 70% for each of the second and third rounds. The psychological experts completed a complementary Delphi survey to reach a consensus on tools to use to assess more complex psychological domains in children and adolescents. For the psychological experts, the first round included 10 open-ended questions on preferred screening tools for depression, anxiety, catastrophising, sleep problems and stress in children (ages 6-9 years old) and adolescents (ages 10-19 years old) as well as on other domains suggested for investigation. In the second round, the psychological experts received a 9-item questionnaire to prioritise the suggested instruments from most to least recommended. RESULTS: The TMD experts, after three Delphi rounds, reached consensus on the changes of DC/TMD to create a form to evaluate Axis II in children and adolescents with TMD complaints. The psychological experts added tools to assess depression and anxiety, sleep disorders, catastrophising, stress and resilience. CONCLUSION: Through international expert consensus, this study adapted Axis II of the adult DC/TMD to assess psychosocial functioning and pain-related disability in children and adolescents. The adapted Axis II protocols will be validated in the target populations.

Standardized palpation of the temporalis muscle evoke referred pain and sensations in individuals without TMD.

OBJECTIVES: This study aimed to determine if standardized palpations of the temporalis muscle evoke referred pain and/or sensations in individuals without TMD. MATERIALS AND METHODS: This was a randomized, single-blinded study. The mechanical sensitivity of the right temporalis muscle was assessed in 32 participants without TMD with nine different stimulations to 15 test sites using palpometers (different stimulus intensities (0.5, 1.0, and 2.0 kg) and durations (2, 5, and 10 s). After each stimulus, participants were asked to score perceived pain intensity and intensity of unpleasantness on a 0-100 numeric rating scale as an indicator of mechanical sensitivity in the temporalis muscle and to indicate any areas of referred pain/sensations on a body chart. RESULTS: Pain intensity significantly differed between palpation durations, intensities, and test sites (P < 0.001). In contrast, unpleasantness significantly differed between palparation duration and intensities (P < 0.001), but not test sites. Participants more frequently reported referred pain/sensations evoked by the 10-s (34.4%) as opposed to the 2-s (6.3%) and 5-s (15.6%) palpation duration at the 2.0-kg stimulus intensity (P < 0.05). CONCLUSIONS: Our present results indicate that referred pain/sensations in the orofacial region can be evoked by standardized palpation of the temporalis muscle and influenced by the palpation duration in individuals without TMD. CLINICAL RELEVANCE: Referred pain/sensations from the temporalis muscle were duration- and intensity-dependent processes originating from local stimuli.

Overlapping Features in Kawasaki Disease-Related Arthritis and Systemic-Onset Juvenile Idiopathic Arthritis: A Nationwide Study in Japan.

Background: Arthritis may occur after the diagnosis of Kawasaki disease (KD). Most cases are self-limiting; however, some patients require prolonged treatment. Method: To characterize KD-related arthritis, 14 patients who required arthritis treatment within 30 days after the diagnosis of KD were recruited from the 23rd KD survey in Japan. Twenty-six additional patients were included from our tertiary center and literature review cohorts. Results: The estimated prevalence of KD-related arthritis in Japan was 48 per 100,000 KD patients. Patients with KD-related arthritis had an older age at onset (52 vs. 28 months, P = 0.002) and higher rate of intravenous immunoglobulin (IVIG) resistance in comparison to those without arthritis (86 vs. 17%, P < 0.001). Among 40 patients, 18 had arthritis in the acute phase KD (continued fever-onset type) and 22 did in the convalescent phase (interval fever-onset type). Both showed a similar rate of complete KD or IVIG response. Interval-type patients required biologics for arthritis control less frequently (5 vs. 39%, P = 0.02) and had a higher 2-year off-treatment rate (100 vs. 43%, P = 0.009) than continued-type ones. Interval-types showed lower serum ferritin and interleukin-18 levels than continued-types. When continued-types were grouped according to whether or not they required biologics (n = 7 and n = 11, respectively), the former subgroup had higher ferritin and interleukin-18 levels (P = 0.01 and 0.02, respectively). A canonical discriminant analysis differentiated interval-type from continued-type with the combination of age, time to arthritis, and the ferritin and matrix metalloproteinase-3 levels. Conclusion: Arthritis requiring treatment is a rare complication of KD. KD-associated arthritis includes interval-type (KD-reactive) and continued-type (true systemic-onset juvenile idiopathic arthritis [JIA] requiring biologics), and overlapping arthritis, suggesting the pathophysiological continuity of autoinflammation between KD and JIA.

Drop homotopic effects of masseter-muscle pain on somatosensory sensitivity in healthy participants.

Current pain classifications use 1.0-kg palpation of the masseter muscle to distinguish between "pain patients" and "healthy controls" but a thorough understanding of the normal physiological responses to various somatosensory stimuli is lacking. The aim of this study was to investigate somatosensory function of the skin over the masseter muscle in healthy participants that were divided into a masseter pain prone group (MPP) (n = 22) and non-MPP group (n = 22), according to the response to a 1.0-kg palpation. Quantitative sensory testing (QST) was performed at the skin above the right masseter muscle (homotopic). In an additional experiment, 13 individuals each from MPP and non-MPP received application of 60% topical lidocaine tape to the skin over the masseter muscle for 30 min. Immediately after, mechanical pain sensitivity (MPS), dynamic mechanical allodynia, and pressure pain threshold were tested. Homotopic MPS was significantly higher and PPTs significantly lower in MPP than in N-MPP (P < 0.05). Strikingly, no other differences in QST outcomes were observed between the groups (P > 0.05). After lidocaine application, no significant differences in homotopic MPS were observed between groups. The presence or absence of acute provoked pain in masseter muscle is exclusively associated with differences in homotopic MPS which is decreased following topical anesthesia.

Diagnostic criteria for temporomandibular disorders (DC/TMD) for children and adolescents: An international Delphi study-Part 1-Development of Axis I.

BACKGROUND: Since in children and adolescence prevalence is assessed mainly on self-reported or proxy-reported signs and symptoms; there is a need to develop a more comprehensive standardised process for the collection of clinical information and the diagnosis of TMD in these populations. OBJECTIVE: To develop new instruments and to adapt the diagnostic criteria for temporomandibular disorders (DC/TMD) for the evaluation of TMD in children and adolescents. METHOD: A modified Delphi method was used to seek international consensus among TMD experts. Fourteen clinicians and researchers in the field of oro-facial pain and TMD worldwide were invited to participate in a workshop initiated by the International Network for Orofacial Pain and Related Disorders Methodology (INfORM scientific network) at the General Session of the International Association for Dental Research (IADR, London 2018), as the first step in the Delphi process. Participants discussed the protocols required to make physical diagnoses included in the Axis I of the DC/TMD. Thereafter, nine experts in the field were added, and the first Delphi round was created. This survey included 60 statements for Axis I, and the experts were asked to respond to each statement on a five-item Likert scale ranging from 'Strongly disagree' to 'Strongly agree'. Consensus level was set at 80% agreement for the first round, and at 70% for the next. RESULTS: After three rounds of the Delphi process, a consensus among TMD experts was achieved and two adapted DC/TMD protocols for Axis I physical diagnoses for children and adolescents were developed. CONCLUSION: Through international consensus among TMD experts, this study adapted the Axis I of the DC/TMD for use in evaluating TMD in children and adolescents.

Comparison of 0.5% chlorhexidine gluconate alcohol with 10% povidone-iodine for skin disinfection in children to prevent blood culture contamination.

INTRODUCTION: Various disinfectants, such as povidone iodine (PVI)1, alcohol preparations, and chlorhexidine gluconate ethanol (CHG-ALC), are used for disinfection prior to blood sampling for culture. METHODS: This retrospective cohort study compared the usefulness and effectiveness of CHG-ALC and PVI in pediatric venipuncture. We applied 0.5% w/v CHG-ALC or 10% PVI as an antiseptic for phlebotomies on pediatric outpatients and inpatients with suspected bacterial infection between November 2017 and April 2019. We conducted logistic regression analysis to define the differences associated with the choice of disinfectant, collection site, and the staff member collecting the blood sample (explanatory variables) and the presence of contamination (objective variable). Based on these results, we performed propensity score matching. RESULTS: The total number of specimens was 1460. The propensity score matching indicated that CHG-ALC reduced the incidence of blood culture contamination more effectively than PVI (0.4%, 2/479 cultures versus 2.5%, 12/479 cultures; relative risk, 0.163 [95% confidence interval, 0.036 to 0.733]; P = 0.012). There were no differences in the contamination rates between cultures of blood drawn from a vascular catheter and those of blood obtained percutaneously. Higher contamination rates were found when junior residents performed the venipuncture. CONCLUSIONS: Compared with PVI, CHG-ALC dries rapidly with no pigmentation and has a long-lasting antiseptic effect. Overall, CHG-ALC skin preparations were more efficacious than the PVI preparations for blood sampling in children.

Risk Factors of Coronary Artery Abnormalities and Resistance to Intravenous Immunoglobulin Plus Corticosteroid Therapy in Severe Kawasaki Disease: An Analysis of Post RAISE.

BACKGROUND: Coronary artery abnormalities (CAAs) still occur in patients with Kawasaki disease receiving intensified treatment with corticosteroids. We aimed to determine the risk factors of CAA development and resistance to intensified treatment in Post RAISE (Prospective Observational Study on Stratified Treatment With Immunoglobulin Plus Steroid Efficacy for Kawasaki Disease)-the largest prospective cohort of Kawasaki disease patients to date. METHODS: In Post RAISE, 2648 consecutive patients with Kawasaki disease were enrolled. The present study analyzed 724 patients predicted to be intravenous immunoglobulin (IVIG) nonresponders (Kobayashi score ≥5) who received intensified treatment consisting of IVIG plus prednisolone. The association between the baseline characteristics and CAA at 1 month after disease onset was examined. The association between the baseline characteristics and treatment resistance was also investigated. RESULTS: Maximum Z score at baseline ≥2.5 (odds ratio, 3.4 [95% CI, 1.5-7.8]), age at fever onset <1 year (odds ratio, 3.4 [95% CI, 1.6-7.4]), and nonresponsiveness to IVIG plus prednisolone treatment (odds ratio, 6.8 [95% CI, 3.3-14.0]) were independent predictors of CAA development. Nonresponsiveness to IVIG plus prednisolone was significantly associated with 8 baseline variables. Baseline total bilirubin (odds ratio, 1.4 [95% CI, 1.2-1.7]) was the only significant independent predictor other than the variables included in the Kobayashi score, enabling treatment resistance to be identified at diagnosis. The area under the ROC curve was 0.74 (95% CI, 0.69-0.79). At a cutoff point of 1.0, the sensitivity and specificity for predicting treatment resistance were 71% and 65%, respectively. CONCLUSIONS: In Post RAISE, younger age at fever onset, a larger maximum Z score at baseline, and nonresponsiveness to IVIG plus prednisolone were risk factors significantly associated with CAA development. Nonresponders were able to be identified at diagnosis based on the total bilirubin value. To prevent CAA, more intensified or adjunctive therapies using other agents, such as pulsed methylprednisolone, ciclosporin, infliximab, and Anakinra, should be considered for patients with these risk factors. Registration: URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000007133.

Relationship between intrapartum antibiotic prophylaxis and group B streptococcal colonization dynamics in Japanese mother-neonate pairs.

INTRODUCTION: In Japan, universal screening for group B streptococcal (GBS) colonization in pregnant women and intrapartum antibiotic prophylaxis (IAP) are recommended to prevent neonatal GBS infection. However, the dynamics of GBS colonization in Japanese mother/neonate pairs have not been adequately studied. METHODS: A prospective cohort study was conducted from July 2018 to March 2019. Rectovaginal samples were collected from pregnant women (33-37 gestation weeks) once. In neonates, nasopharyngeal and rectal samples were collected at three time points: after birth, 1 week after birth, and 1 month after birth. All samples were analyzed for GBS using real-time PCR testing and culture methods. Capsular typing was performed for all GBS isolates and GBS-positive samples using real-time PCR testing. RESULTS: The overall maternal and neonatal GBS-positivity rates were 22.7% (57/251) and 8.8% (22/251), respectively. IAP for GBS-positive mothers (96.5%) was highly administered. Eleven (19.3%) neonates born to GBS-positive mothers were GBS-positive, which was significantly higher than the 11 (5.7%) neonates born to GBS-negative mothers. The rate of GBS-positivity in neonates increased with an increased number of GBS colonies in mothers. More neonates were GBS-positive 1 month after birth than 1 week after birth, and there was a higher rate of GBS-positive rectal swabs than nasopharyngeal swabs. Capsular types of GBS that were isolated from each mother and neonate pair were the same, namely, Ib, III, V, and VI. CONCLUSIONS: These findings indicate that the efficacy of IAP in preventing GBS transmission to neonates might be limited to within a few weeks after birth.