Pediatric Sinus Research Articles

Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States.

The lack of label information for the pediatric population has been a global issue, leading to the introduction of several countermeasures by major health authorities. Despite various efforts by Japanese health authorities, some drugs are approved only for adults in Japan, while the United States (US) label includes information on pediatric usage for the same drugs. This suggests a potential for pediatric-specific drug loss in Japan, where overall drug loss has recently become a major concern. In this study, we compared the pediatric usage status between Japan and the US, focusing on the indications approved in both countries. Of the 404 indications, 70 (17.3%) and 102 (25.2%) included pediatric usage in Japan and the US, respectively. The proportion of indications, including pediatric usage, was significantly higher in the US than in Japan (χ2 test, p < 0.001). Multivariate analysis of indications for pediatric usage in the US demonstrated that simultaneous development with adults (odds ratio (OR), 24.9; 95% confidence interval (CI), 6.79-91.1) and Japan-first development (OR, 31.5; 95% CI, 2.59-384) were significantly affecting the inclusion of pediatric usage in Japan. Our results suggest that there was pediatric-specific drug loss in Japan compared to that in the US. The multivariate analysis demonstrated that US-first development and non-simultaneous development had a negative impact on the inclusion of pediatric usage in Japan; however, pediatric assessment request was not a significant factor. Further frameworks to promote pediatric drug development should be introduced in Japan to address pediatric-specific drug loss issues.

Testing of New Drugs Approved From 2015 Through 2021 Under the US Pediatric Research Equity Act

This study uses public US Food and Drug Administration lists to identify new drugs approved from 2015 through 2021 to examine recent estimates of compliance with and timing of pediatric testing requirements after passage of the Pediatric Research Equity Act.

Respiratory Syncytial Virus and US Pediatric Intensive Care Utilization

Bronchiolitis is the most common diagnosis necessitating respiratory support and pediatric intensive care, and respiratory syncytial virus (RSV) is the most common cause of bronchiolitis. In 2023, the monoclonal antibody nirsevimab and the maternal RSVpreF vaccine were implemented to prevent RSV in infants. To determine the potential association of novel RSV prevention strategies with pediatric intensive care unit (ICU) utilization. This retrospective cross-sectional study examined US pediatric ICU encounters with and without RSV from January 1, 2017, to June 1, 2023. Data were from Oracle Cerner RealWorld Data, a national electronic health record database. All children (aged >1 day and <18 years) admitted to an ICU during the study period were included in the analysis. Statistical analysis was performed from February to May 2024. The primary outcomes were ICU encounters with RSV and ICU encounters with RSV eligible for RSV prevention. There were 119 782 ICU encounters from 53 hospitals; 65 757 encounters (54.9%) were male; median (IQR) age was 4.5 (1.1-12.5) years, median (IQR) ICU length of stay was 1.8 (1.0-3.9) days; 13 702 ICU encounters (11.4%) had RSV, of which 38.6% (5217) were eligible for prevention (4.4% of total ICU encounters). Encounters with RSV accounted for 21.1% (109 334) of ICU days, of which 43.8% (47 888) were eligible for prevention (9.2% of total ICU days). Encounters with RSV were associated with a greater use of positive pressure ventilation (4074 [29.7%] vs 18 821 [17.7%]; P < .001) and vasoactive medications (3057 [22.3%] vs 18 570 [17.5%]; P < .001) compared with those without RSV. The findings of this retrospective cross-sectional study of RSV and US pediatric intensive care utilization suggest that if 65% to 85% of eligible children received RSV prevention, an estimated 2.1% to 2.8% reduction in pediatric ICU encounters and an estimated 4.5% to 5.9% reduction in pediatric ICU days could be achieved.

Trends in US Pediatric Asthma Hospitalizations, by Race and Ethnicity, 2012-2020.

Some racial and ethnic minority communities have long faced a higher asthma burden than non-Hispanic White communities. Prior research on racial and ethnic pediatric asthma disparities found stable or increasing disparities, but more recent data allow for updated analysis of these trends. Using 2012-2020 National Inpatient Sample data, we estimated the number of pediatric asthma hospitalizations by sex, age, and race and ethnicity. We converted these estimates into rates using data from the US Census Bureau and then conducted meta-regression to assess changes over time. Because the analysis spanned a 2015 change in diagnostic coding, we performed separate analyses for periods before and after the change. We also excluded 2020 data from the regression analysis. The number of pediatric asthma hospitalizations decreased over the analysis period. Non-Hispanic Black children had the highest prevalence (range, 9.8-36.7 hospitalizations per 10,000 children), whereas prevalence was lowest among non-Hispanic White children (range, 2.2-9.4 hospitalizations per 10,000 children). Although some evidence suggests that race-specific trends varied modestly across groups, results overall were consistent with a similar rate of decrease across all groups (2012-2015, slope = -0.83 [95% CI, -1.14 to -0.52]; 2016-2019, slope = -0.35 [95% CI, -0.58 to -0.12]). Non-Hispanic Black children remain disproportionately burdened by asthma-related hospitalizations. Although the prevalence of asthma hospitalization is decreasing among all racial and ethnic groups, the rates of decline are similar across groups. Therefore, previously identified disparities persist. Interventions that consider the specific needs of members of disproportionately affected groups may reduce these disparities.

Endovascular management of pediatric pial arteriovenous fistulas with hereditary GDF2 mutation: illustrative case.

Intracranial pial arteriovenous fistulas (PAVFs) are uncommon neurovascular anomalies that primarily affect the pediatric population. PAVFs are often linked to hereditary hemorrhagic telangiectasia, yet the specific genetic mutations remain unidentified. While endovascular embolization is the preferred treatment for PAVFs, complications like hydrocephalus and sinus thrombosis pose challenges in management. The authors present a rare case of PAVF in a 6-month-old male neonate with a hereditary GDF2 mutation, where the fistula was supplied by the posterior inferior cerebellar artery and drained directly into the sigmoid sinus. The PAVF was effectively treated with endovascular embolization using coils and Onyx. Furthermore, the authors describe the successful use of rivaroxaban in managing subsequent sinus thrombosis after the embolization of PAVFs. Additionally, the authors review treatment strategies and complications following fistula disconnection. Endovascular embolization is the primary treatment choice for the majority of pediatric PAVFs, while a hereditary GDF2 mutation is considered a potential contributing factor to the formation of these malformations in children. Rivaroxaban has shown promise as an effective therapeutic option for pediatric sinus thrombosis, supported by its established safety profile. https://thejns.org/doi/10.3171/CASE24182.

Skiing Injuries in the US Pediatric Population: An Analysis of National Injury Trends and Mechanisms Between 2012 and 2022.

While prevention protocols have been implemented, skiing-related musculoskeletal injuries and concussions continue to present to emergency departments in the United States. Previous literature has suggested the pediatric population may constitute up to 40% of skiing-related injuries. To assess injury trends and the underlying mechanisms of skiing injuries in pediatric patients seen at emergency departments in the United States. Descriptive epidemiology study. The National Electronic Injury Surveillance System (NEISS) was queried for pediatric (age ≤18 years) skiing injuries between January 1, 2012, and December 31, 2022. Injury mechanism, location, disposition, and diagnosis were recorded, and the statistical sample weight assigned by NEISS by hospital was used to calculate national estimates (NEs). Injury trends were evaluated with linear regression analysis. Overall, 2951 pediatric skiing injuries were included (NE = 123,386). The mean age of the patients was 12.4 ± 3.5 years, with 61.3% of the injuries occurring in male patients. Impact with the ground was the most common injury mechanism (NE = 87,407; 70.8%). Fractures were the most common diagnosis (NE = 38,527, 31.2%), followed by strains/sprains (NE = 22,562, 18.3%), contusions/abrasions (NE = 16,257, 13.2%), and concussions (NE = 12,449, 10.1%). The lower leg was the most common fracture site (NE = 9509, 24.7%), followed by the shoulder (NE = 7131, 18.5%) and lower arm (NE = 5876, 15.3%). Analysis of annual injuries revealed no significant trend between 2012 and 2022 (P = .17), with fluctuations apparent throughout the study period. Significant decreases were seen in strains/sprains (P < .01) and contusions/abrasions (P < .01), but not in concussions (P = .57) or fractures (P = .70). Impacts with the snow/ground made up 70.8% of all injuries. Fractures were the most common injury diagnosis, followed by strains/sprains, with the lower leg being most frequently fractured. While strains/sprains and contusions/abrasions showed a significant decline, there were no significant trends in fractures and concussions between 2012 and 2022.

Mobile ECG devices in pediatric cardiology: efficacy and accuracy of smart watch and hand-held device in healthy children

Abstract Background and Aim Pediatric arrhythmias require accurate electrocardiogram (ECG) assessment for diagnosis and management. Mobile ECG devices, such as smart watch based and hand-held devices, offer potential advantages in terms of portability and accessibility. This study aimed to compare the efficancy and diagnostic accuracy of ECG tracings obtained using a smart watch and a hand-held device with standard 12-lead ECG tracings in healthy children. Methods ECG data were acquired from healthy pediatric subjects (n=30) aged 4 to 18 years using the smart watch, hand-held device, and standard 12-lead ECG. Single leads were acquired sequentially. The time required for ECG acquisition was recorded for each device. Subsequently, ECG leads were analyzed for voltage, duration, and morphology of waves and intervals, as well as ST segments. Qualitative assessment of leads included morphology comparison of waves and complexes to standard 12-lead ECG and using a physician based quality rating scale. Assessment was performed by two blinded pediatric electrophysiologists. Results We found significant differences in the time required to acquire ECG tracings between the smart watch, standard 12-lead ECG, and hand-held device, with the smart watch being notably slower (median 15 min, 4 min, 1 min, respectively). ECG leads obtained with the smart watch and hand-held device demonstrated comparability to standard 12-lead ECG tracings in terms of quantitative key parameters, including voltage (mV) and duration (ms) of waves and intervals. Qualitative assessment revealed good correlation of the hand-held device with standard 12-lead ECG, while the smart watch performed less well. Conclusions This study suggests that mobile ECG devices offer a diagnostic accuracy comparable to that of standard 12-lead ECGs in healthy children. While the smart watch may be slower in ECG acquisition, acquisition of all 12 standard ECG leads is feasible in this population. The potential of both included mobile devices for pediatric usage in specific clinical scenarios, such as remote monitoring or emergencies, is promising.Graphical Abstract

Precocious Puberty and GnRH Analogs: Current Treatment Practices and Perspectives among US Pediatric Endocrinologists.

Gonadotropin releasing hormone analogs (GnRHas) are used for treatment of precocious puberty. Over the last decade, several new formulations have been approved. The Drugs and Therapeutics Subcommittee of the Pediatric Endocrine Society (PES) undertook a review to ascertain the current treatment options, prescribing behaviors, and practices of GnRHas among pediatric endocrinologists practicing within the USA. The survey consisted of four main subsections: (1) description of clinical practice; (2) self-assessment of knowledge base of pediatric and adult GnRHa formulations; (3) current practice for treating central precocious puberty (CPP); and (4) utilization of healthcare resources. There were 223 survey respondents. Pediatric endocrine practitioners were most familiar with the pediatric one-monthly preparation, the 3-month preparation, and the histrelin implant (Supprelin®) (88%, 96%, and 91%, respectively), with lower familiarity for 24-week triptorelin intramuscular (Triptodur®) (65%) and 6-month subcutaneous leuprolide (Fensolvi®) (45%). Only 23% of the respondents reported being extremely familiar with the availability of adult formulations, and 25% reported being completely unaware of cost differences between pediatric and adult GnRHa preparations. The implant was the most preferred therapy (44%), but in practice, respondents reported a higher percentage of patients treated with the 3-month preparation. While family preference/ease of treatment (87%) was the key determinant for using a particular GnRHa preparation, insurance coverage also played a significant role in the decision (64%). Responses regarding assessment for efficacy of treatment were inconsistent, as were practices and criteria for obtaining an MRI. The survey indicated there is more familiarity with older, shorter acting GnRHas, which are prescribed in greater numbers than newer, longer acting formulations. There is lack of consensus on the need for central nervous system (CNS) imaging in girls presenting with CPP between 6 and 8 years of age and use of laboratory testing to monitor response to treatment. Insurance requirements regarding CNS imaging and laboratory monitoring are highly variable. Despite having similar constituents and bioavailability, there are substantial cost differences between the pediatric and adult formulations and lack of evidence for safe use of these formulations in children. The survey-based analysis highlights the challenges faced by prescribers while reflecting on areas where further research is needed to provide evidence-based practice guidelines for pediatric endocrinologists.

Formulation and Evaluation of Polyherbal Hematinic Capsule for Pediatrics

Hematinic deficiencies in children, including those related to iron, folic acid, and vitamin B12, are a serious health issue that impact a child's growth, development, and general wellbeing. Administration of dose, taste, and compliance are common problems with conventional therapies. To address these issues, the production and testing of polyherbal hematinic capsules intended for pediatric usage is the main focus of this work. Strong hematinic properties in plant extracts are selected with care, and the right processing methods are used for young users. The capsule size is adjusted for ease of swallowing, and the polyherbal mixture is improved to increase compliance. To ascertain the effectiveness, safety, and suitability for use in pediatric settings, testing is done. The created polyherbal hematinic capsules exhibit outstanding disintegration time, flow characteristics, and an hourly cumulative drug release of 97.7%. The results imply that hematinic polyherbal capsules have potential as a safe and efficient option for treating paediatric hematinic deficits, addressing compliance concerns and providing an appealing dose form.

Brain drain in pediatric anesthesiology: The geographic and demographic distribution of national origin among pediatric anesthesiologists in the United States.

American pediatric anesthesiologists have a long history of international volunteerism. However, the US healthcare system also benefits from the contributions of a large number of physicians who come from other nations to work within its borders. Despite this fact, little is known about the contribution of international medical graduates (IMG) to the pediatric anesthesiology subspecialty. To characterize the contribution of IMG to the field of pediatric anesthesiology in the United States, and to elucidate the geographic and demographic distribution of their national origins so as to understand the movement of skilled personnel between countries. Online physician directories of American children's hospitals were searched, and anesthesiologists were recorded for their national origin of medical education. International graduates were reported as a percentage of the pediatric anesthesiology workforce. Those attending medical colleges catering to American students ("offshore" medical schools) were analyzed separately from other IMGs. The cohort of non-offshore IMGs were analyzed for national and continental origins, and by national level of economic development. Of 1979 anesthesiologists analyzed, 397 attended medical school outside the United States, with 58 being from offshore schools. The remaining 338 represented 17.1% of the total pediatric anesthesiology workforce. They came from 58 countries on six continents. Of those, 65.1% attended medical school in low- and middle-income countries. International medical graduates, disproportionately from low- and middle-income countries, compose a large proportion of the US Pediatric Anesthesiology workforce. While these clinicians play a vital role in providing care for American children, the potential impacts of skilled physician loss on their nations of origin must also be considered.

Social Care Education and Training Among US Pediatric Emergency Medicine Fellowship Programs.

The aim of the study is to assess the association of social determinants of health (SDOH) education and social needs training on pediatric emergency medicine (PEM) physician perception and practices of social care. Data were derived from the 2021 National Social Care Practices Survey of PEM program directors (PDs) and fellows. Ordinal and binary logistic regression modeling were completed for educational/training factors and social care perspective and practice outcomes. A national sample of 44 PDs (49% response rate) and 109 fellows (28%) participated. A minority of fellows received SDOH education and social needs training during fellowship. Fellows and PDs with SDOH education had a 3.1 odds (95% confidence interval CI, 1.4-6.9) of screening for social needs, with 4.4 odds among fellows (95% CI, 1.2-20.7). Those with social needs training were more comfortable assessing social risk, with 2.4 odds overall (95% CI, 1.2-4.7) and 3.1 odds among fellows (95% CI, 1.4-6.7). They also had 2.4 odds overall (95% CI, 1.1-4.9) of screening for social needs, with a 2.9 odds among fellows (95% CI, 1.3-6.8). Social care education and training appear to be associated with comfort assessing social risk and social needs screening tendency among both PEM PDs and fellows. Key areas for educational interventions are identified among PEM fellows, who are uniquely positioned as clinical leaders and patient advocates.

(114) - Socioeconomic Deprivation Predicts Worse Post-Transplant Survival in US Pediatric Heart Transplantation

(114) - Socioeconomic Deprivation Predicts Worse Post-Transplant Survival in US Pediatric Heart Transplantation

Berenice's Legacy, Ending Silence, and Serving Justice: A Call for Comprehensive Chagas Testing in the US Pediatric Population.

Berenice's Legacy, Ending Silence, and Serving Justice: A Call for Comprehensive Chagas Testing in the US Pediatric Population.

Mouth dissolving film as a potential dosage form for paediatric usage

Drug delivery systems using thin films are being researched by the pharmaceutical industry. They're a diverse platform that can provide immediate, local, or systemic actions. Furthermore, these systems can be used independently, which is ideal for patients with dysphagia, elderly, pediatric, or bed-ridden patients, as well as those who may have difficulty consuming water. These drug delivery systems can be given by oral, buccal, sublingual, ocular and trans-dermal routes. This study explores mouth thin films in all of their characteristics from the current perspective, providing insight into the world's growing market share as a result of expanding research fields and technological breakthroughs. Simultaneously, It provides a summary of the key factors involved in formulation development that have an impact on thin films, such as thin film design, morphological and physiological limitations, production process selection, characterization techniques, and polymer and drug physicochemical properties. It also gives an overview of the most recent thin-film products made by major pharmaceutical firms.

Child Health and the US Pediatric Subspecialty Workforce: Planning for the Future.

This article opens a multi-article Pediatrics supplement that provides a rigorous analysis of the projected pediatric subspecialty workforce in the United States. Congenital variations, epigenetics, exposures, lifestyle, preventive care, and medical interventions from conception through young adulthood set the stage for health and wellbeing in adulthood. Although care provided by pediatric subspecialists is associated with better outcomes and lower costs compared with adult providers, the authors of recent articles in the lay and medical literature have questioned the capacity of pediatric subspecialists to meet children’s health care needs. This article highlights that, despite numerous advances in prevention, diagnosis, and treatment, the last decade has witnessed increasing numbers of children with acute or chronic physical and mental health disorders, including medical complexity, obesity, type 2 diabetes, anxiety, depression, and suicidality, all of which are exacerbated by poverty, racism, and other social drivers of health. In this article, we then describe the variability in the demographics, practice characteristics, and geographic distribution of the 15 core pediatric subspecialties certified by the American Board of Pediatrics. We then discuss the rationale and approach to the development of a pediatric subspecialty workforce model that forecasts subspecialist supply from 2020 to 2040 for 14 subspecialties at the national and subnational levels (not including the newest subspecialty, pediatric hospital medicine), accounting for US Census Bureau child population projections. The model does not account for the unique physical and mental needs of individual children, nor does it address the increasingly precarious commitment to, and financing of, pediatric subspecialty care in the US health care system impacting market demand.

Recipient Proximity to Transplant Center in US Pediatric Kidney Transplantation

Recipient Proximity to Transplant Center in US Pediatric Kidney Transplantation

US Pediatric Primary Care Physician Workforce in Rural Areas, 2010 to 2020

This cross-sectional study examines the growth and distribution of the general pediatrician and family medicine physician workforce from 2010 to 2020 across the US and identifies the sociodemographic characteristics of counties lacking this workforce.

Pediatric Functional Rhinoplasty.

Surgery on the growing pediatric nose poses many questions regarding the indications and proper timing. Historically, surgeries on the pediatric nose led to facial growth alterations so many urged caution and waiting until skeletal maturity at the age of 18. However, animal studies showed some promise that facial growth may not be affected. Investigations into effects of pediatric sinus surgery and septal surgery on facial growth showed no issues. The external nose is somewhat different in that minor variations potentially can grow to a cosmetic deformity. However, numerous studies on facial growth show, to date, that it is not affected, and that surgery is safe. The caveat that one uses is the techniques of cartilage sparing and preservation, which have been studied and shown to be safe. There are ways to measure the effectiveness of surgery in relieving nasal airway obstruction both objectively and, more recently, subjectively. It is essential to treat pediatric nasal airway obstruction to avoid other facial growth problems, such as mouth breathing, snoring, malocclusion, and obstructive sleep apnea.

Radiation dose reduction using spectral shaping in pediatric non-contrast sinus CT.

CT is the standard imaging technique to evaluate pediatric sinuses. Given the potential risks of radiation exposure in children, it is important to reduce pediatric CT dose and maintain image quality. To study the utility of spectral shaping with tin filtration to improve dose efficiency for pediatric sinus CT exams. A head phantom was scanned on a commercial dual-source CT using a conventional protocol (120kV) and a proposed 100kV with a 0.4-mm tin filter (Sn100 kV) protocol for comparison. Entrance point dose (EPD) of eye and parotid gland region was measured by an ion chamber. Sixty pediatric sinus CT exams (33 acquired with 120kV, 27 acquired with Sn100 kV) were retrospectively collected. All patient images were objectively measured for image quality and blindly reviewed by 4 pediatric neuroradiologists for overall noise, overall diagnostic quality, and delineation of 4 critical paranasal sinus structures, using a 5-point Likert scale. Phantom CTDIvol from Sn100 kV is 4.35mGy, compared to CTDIvol of 5.73mGy from 120kV at an identical noise level. EPD of sensitive organs decreases in Sn100 kV (e.g., right eye EPD 3.83±0.42mGy), compared to 120kV (5.26±0.24mGy). Patients in the 2 protocol groups were age and weight (unpaired T test P>0.05) matched. The patient CTDIvol of Sn100 kV (4.45±0.47mGy) is significantly lower than 120kV (5.56±0.48mGy, unpaired T test P<0.001). No statistically significant difference for any subjective readers' score (Wilcoxon test P>0.05) was found between the two groups, indicating proposed spectral shaping provides equivalent diagnostic image quality. Phantom and patient results demonstrate that spectral shaping can significantly reduce radiation dose for non-contrast pediatric sinus CT without compromising diagnostic quality.

Estimated US Pediatric Hospitalizations and School Absenteeism Associated With Accelerated COVID-19 Bivalent Booster Vaccination

Adverse outcomes of COVID-19 in the pediatric population include disease and hospitalization, leading to school absenteeism. Booster vaccination for eligible individuals across all ages may promote health and school attendance. To assess whether accelerating COVID-19 bivalent booster vaccination uptake across the general population would be associated with reduced pediatric hospitalizations and school absenteeism. In this decision analytical model, a simulation model of COVID-19 transmission was fitted to reported incidence data from October 1, 2020, to September 30, 2022, with outcomes simulated from October 1, 2022, to March 31, 2023. The transmission model included the entire age-stratified US population, and the outcome model included children younger than 18 years. Simulated scenarios of accelerated bivalent COVID-19 booster campaigns to achieve uptake that was either one-half of or similar to the age-specific uptake observed for 2020 to 2021 seasonal influenza vaccination in the eligible population across all age groups. The main outcomes were estimated hospitalizations, intensive care unit admissions, and isolation days of symptomatic infection averted among children aged 0 to 17 years and estimated days of school absenteeism averted among children aged 5 to 17 years under the accelerated bivalent booster campaign simulated scenarios. Among children aged 5 to 17 years, a COVID-19 bivalent booster campaign achieving age-specific coverage similar to influenza vaccination could have averted an estimated 5 448 694 (95% credible interval [CrI], 4 936 933-5 957 507) days of school absenteeism due to COVID-19 illness. In addition, the booster campaign could have prevented an estimated 10 019 (95% CrI, 8756-11 278) hospitalizations among the pediatric population aged 0 to 17 years, of which 2645 (95% CrI, 2152-3147) were estimated to require intensive care. A less ambitious booster campaign with only 50% of the age-specific uptake of influenza vaccination among eligible individuals could have averted an estimated 2 875 926 (95% CrI, 2 524 351-3 332 783) days of school absenteeism among children aged 5 to 17 years and an estimated 5791 (95% CrI, 4391-6932) hospitalizations among children aged 0 to 17 years, of which 1397 (95% CrI, 846-1948) were estimated to require intensive care. In this decision analytical model, increased uptake of bivalent booster vaccination among eligible age groups was associated with decreased hospitalizations and school absenteeism in the pediatric population. These findings suggest that although COVID-19 prevention strategies often focus on older populations, the benefits of booster campaigns for children may be substantial.