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Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regard to, for example, drug response, growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population‐specific factors (e.g., more frequent use of off‐label/unlicensed drugs). In recognition of these challenges, a group of experts has been formed in the context of the conect4children (c4c) project to support paediatric drug development. This expert group collaborated to develop methodological considerations for paediatric drug safety and pharmacovigilance throughout the life‐cycle of medicinal products which are described in this article. These considerations include practical points to consider for the development of the paediatric section of the risk management plan (RMP), safety in paediatric protocol development, safety data collection and analysis. Furthermore, they describe the specific details of post‐marketing pharmacovigilance in children using, for example, spontaneous reports, electronic health care records, registries and record‐linkage, as well as the use of paediatric pharmacoepidemiology studies for risk characterisation. Next the details of the assessment of benefit–risk and challenges related to medicinal product formulation in the context of a Paediatric Investigation Plan (PIP) are presented. Finally, practical issues in paediatric signal detection and evaluation are included. This paper provides practical points to consider for paediatric pharmacovigilance throughout the life‐cycle of medicinal products for RMPs, protocol development, safety data collection and analysis and PIPs. [ABSTRACT FROM AUTHOR]

Improved global access to novel age‐appropriate formulations for paediatric subsets, either of new chemical entities or existing drugs, is a priority to ensure that medicines meet the needs of these patients. However, despite regulatory incentives, the introduction to the market of paediatric formulations still lags behind adult products. This is mainly caused by additional complexities associated with the development of acceptable age‐appropriate paediatric medicines. This position paper recommends the use of a paediatric Quality Target Product Profile as an efficient tool to facilitate early planning and decision making across all teams involved in paediatric formulation development during the children‐centric formulation design for new chemical entities, or to repurpose/reformulate off‐patent drugs. Essential key attributes of a paediatric formulation are suggested and described. Moreover, greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age‐appropriate medicinal products. Acceptability testing should be a secondary endpoint in paediatric clinical trials to ensure postmarketing adherence is not compromised by a lack of acceptability. Not knowing the indications and the related age groups and potential dosing regimens early enough is still a major hurdle for efficient paediatric formulation development; however, the proposed paediatric Quality Target Product Profile could be a valuable collaborative tool for planning and decision making to expedite paediatric product development, particularly for those with limited experience in developing a paediatric product. [ABSTRACT FROM AUTHOR]

Background: Feeding problems are common in children with complex medical problems or acute critical illness and enteral nutrition may be required. In certain situations, gastric tube feeding is poorly tolerated or may not be feasible. When feed intolerance persists despite appropriate adjustments to oral and gastric enteral regimens, jejunal tube feeding can be considered as an option for nutrition support. Methods: A multidisciplinary expert working group of the Australasian Society of Parenteral and Enteral Nutrition was convened. They identified topic questions and five key areas of jejunal tube feeding in children. Literatures searches were undertaken on Pubmed, Embase, and Medline for all relevant studies, between January 2000 and September 2022 (n = 103). Studies were assessed using National Health and Medical Research Council guidelines to generate statements, which were discussed as a group, followed by voting on statements using a modified Delphi process to determine consensus. Results: A total of 24 consensus statements were created for five key areas: patient selection, type and selection of feeding tube, complications, clinical use of jejunal tubes, follow‐up, and reassessment. Conclusion: Jejunal tube feeding is a safe and effective means of providing nutrition in a select group of pediatric patients with complex medical needs, who are unable to be fed by gastric tube feeding. Appropriate patient selection is important as complications associated with jejunal tube feeding are not uncommon, and although mostly minor, can be significant or require tube reinsertion. All children receiving jejunal tube feeding should have multidisciplinary team assessment and follow‐up. [ABSTRACT FROM AUTHOR]

Analysing referral patterns of simple oral surgery to specialist oral surgery providers allows judgement to be made on the referrer's oral surgery competence. Going Paperless-Tracking Morale During the Transition to Electronic Health Records Presenter and Co-author's Names: Gabriele Baniulyte and Norma Rogerson Royal Devon and Exeter Hospital B Background: b In October 2020, Royal Devon & Exeter NHS trust underwent the transition from paper notes to a fully electronic health records (EHR) system representing unprecedented organisational change. The primary objective is to compare risk factors associated with hypoxaemia (SpO2 <= 94%) in ASA I & II patients receiving midazolam with or without fentanyl IV sedation for oral surgery procedures. [Extracted from the article]

The survival of childhood Wilms tumor is currently around 90%, with many survivors reaching reproductive age. Chemotherapy and radiotherapy are established risk factors for gonadal damage and are used in both COG and SIOP Wilms tumor treatment protocols. The risk of infertility in Wilms tumor patients is low but increases with intensification of treatment including the use of alkylating agents, whole abdominal radiation or radiotherapy to the pelvis. Both COG and SIOP protocols aim to limit the use of gonadotoxic treatment, but unfortunately this cannot be avoided in all patients. Infertility is considered one of the most important late effects of childhood cancer treatment by patients and their families. Thus, timely discussion of gonadal damage risk and fertility preservation options is important. Additionally, irrespective of the choice for preservation, consultation with a fertility preservation (FP) team is associated with decreased patient and family regret and better quality of life. Current guidelines recommend early discussion of the impact of therapy on potential fertility. Since most patients with Wilms tumors are prepubertal, potential FP methods for this group are still considered experimental. There are no proven methods for FP for prepubertal males (testicular biopsy for cryopreservation is experimental), and there is just a single option for prepubertal females (ovarian tissue cryopreservation), posing both technical and ethical challenges. Identification of genetic markers of susceptibility to gonadotoxic therapy may help to stratify patient risk of gonadal damage and identify patients most likely to benefit from FP methods. [ABSTRACT FROM AUTHOR]

Aim: Paediatric patients with high‐output ileostomies (HOI) face an elevated risk of complications. This study aimed to comprehensively review the existing literature and offer nutritional management recommendations for paediatric patients with an HOI. Methods: PubMed and Embase were searched for relevant English or French language papers up to 31 June 2022. The emphasis was placed on studies involving paediatric ileostomy patients, but insights were obtained from adult literature and other intestinal failure pathologies when these were lacking. Results: We identified 16 papers that addressed nutritional issues in paediatric ileostomy patients. Currently, no evidence supports a safe paediatric HOI threshold exceeding 20 mL/kg/day on two consecutive days. Paediatric HOI patients were at risk of dehydration, electrolyte disturbances, micronutrient deficiencies and growth failure. The primary dietary choice for neonates is bolus feeding with breastmilk. In older children, an enteral fluid restriction should be installed favouring isotonic or slightly hypotonic glucose‐electrolyte solutions. A diet that is high in calories, complex carbohydrates and proteins, low in insoluble fibre and simple carbohydrates, and moderate in fat is recommended. Conclusion: Adequate nutritional management is crucial to prevent complications in children with an HOI. Further research is needed to establish more evidence‐based guidelines. [ABSTRACT FROM AUTHOR]

Background: There has been a recent focus among anesthesiologists on reducing the use of perioperative opioids in favor of multimodal analgesic regimens. Gabapentin has played an integral role in this evolution of practice. This comprehensive review assesses the current clinical evidence on the efficacy of perioperative gabapentin regarding postoperative pain and opioid requirements among the pediatric surgery population. Data Sources: Pubmed, CINAHL, Embase, Scopus, and Web of Science Review. Methods: This scoping review of the above databases includes all studies examining the use of gabapentin perioperatively in pediatric patients and its association with postoperative pain intensity and postoperative opioid consumption through July 2021. The inclusion criteria encompassed all studies evaluating gabapentin in the perioperative pediatric population through randomized controlled trials (RCTs) and retrospective studies. Relevant metadata from each study were abstracted and descriptive statistics were used to summarize the results. Results: Fifteen papers met the inclusion criteria for this review, including 11 RCTs and 4 retrospective studies. Sample sizes ranged from 20 to 144 patients. Administered doses varied widely, mainly between 5 and 20 mg/kg. The studies included primarily orthopedic (10) and neck surgery cases (3). Seven papers had gabapentin provided preoperatively only, two postoperative only, and six both pre‐ and postoperatively. Of the studies assessing postoperative pain, 6/11 studies saw a decrease in postoperative pain in at least one period for the gabapentin group. Of the studies considering opioid requirements, 6/10 reported a reduction, 1/10 an increase, and 3/10 no difference in opioid requirements for the gabapentin groups. Yet, most of these pain and opioid requirement findings were only significant at one to two time points in the study follow‐up periods, and the actual decreases had minimal clinical significance. Conclusions: The current data on perioperative gabapentin in pediatric patients are insufficient to support the routine use of gabapentin in pediatric patients. Additional high‐quality RCTs with more standardized protocols for gabapentin administration and outcome measures are necessary to provide more definitive conclusions. [ABSTRACT FROM AUTHOR]

Aim: Our aim was to summarise the evidence about flexible bronchoscopy for paediatric airway foreign body aspiration cases. Methods: We searched the PubMed database from 1 January 2001 to 9 October 2021 for peer‐review papers published in English on the use, and success rates, of flexible bronchoscopy as the first‐line treatment for foreign body aspiration cases. This process identified 243 potential papers. Results: We studied 23 papers comprising 2588 cases of foreign body aspiration and flexible bronchoscopy successfully removed the foreign bodies in 87.1% of cases. Complication rates were low in the 983 patients studied in 18 papers. The foreign bodies were organic materials in 78.3% of 1371 patients and mainly lodged in the right bronchial tree in 50.5% of 1402 patients. General anaesthesia was used before flexible bronchoscopy in 14/23 studies and laryngeal mask airways were mostly used in 10/23 studies to secure the airway during the procedure. Ancillary equipment was used to assist the foreign body removal in 57.3% of 1808 cases and these were usually baskets. Conclusion: Flexible bronchoscopy was a feasible and safe therapeutic procedure for selected foreign body aspiration cases. Future studies need to focus on comparing the clinical outcomes of flexible and rigid bronchoscopies. [ABSTRACT FROM AUTHOR]

Magnetoencephalography (MEG) is a neurophysiological technique based on the detection of brain magnetic fields. Whole‐head MEG systems typically house a few hundred sensors requiring cryogenic cooling in a rigid one‐size‐fits‐all (commonly adult‐sized) helmet to keep a thermal insulation space. This leads to an increased brain‐to‐sensor distance in children, because of their smaller head circumference, and decreased signal‐to‐noise ratio. MEG allows detection and localization of interictal and ictal epileptiform discharges, and pathological high frequency oscillations, as a part of the presurgical assessment of children with refractory focal epilepsy, where electroencephalography is not contributive. MEG can also map the eloquent cortex before surgical resection. MEG also provides insights into the physiopathology of both generalized and focal epilepsy. On‐scalp recordings based on cryogenic‐free sensors have demonstrated their use in the field of childhood focal epilepsy and should become a reference technique for diagnosing epilepsy in the paediatric population. What this paper adds: Magnetoencephalography (MEG) contributes to the diagnosis and understanding of paediatric epilepsy.On‐scalp MEG recordings demonstrate some advantages over cryogenic MEG. What this paper adds: Magnetoencephalography (MEG) contributes to the diagnosis and understanding of paediatric epilepsy.On‐scalp MEG recordings demonstrate some advantages over cryogenic MEG. [ABSTRACT FROM AUTHOR]

Introduction: Diarrhea is still a significant global public health problem. There are currently no systematic evaluation of the modeling areas and approaches to predict diarrheal illness outcomes. This paper reviews existing research efforts in predictive modeling of infectious diarrheal illness in pediatric populations. Methods: We conducted a systematic review via a PubMed search for the period 1990–2021. A comprehensive search query was developed through an iterative process and literature on predictive modeling of diarrhea was retrieved. The following filters were applied to the search results: human subjects, English language, and children (birth to 18 years). We carried out a narrative synthesis of the included publications. Results: Our literature search returned 2671 articles. After manual evaluation, 38 of these articles were included in this review. The most common research topic among the studies were disease forecasts 14 (36.8%), vaccine‐related predictions 9 (23.7%), and disease/pathogen detection 5 (13.2%). Majority of these studies were published between 2011 and 2020, 28 (73.7%). The most common technique used in the modeling was machine learning 12 (31.6%) with various algorithms used for the prediction tasks. With change in the landscape of diarrheal etiology after rotavirus vaccine introduction, many open areas (disease forecasts, disease detection, and strain dynamics) remain for pathogen‐specific predictive models among etiological agents that have emerged as important. Additionally, the outcomes of diarrheal illness remain under researched. We also observed lack of consistency in the reporting of results of prediction models despite the available guidelines highlighting the need for common data standards and adherence to guidelines on reporting of predictive models for biomedical research. Conclusions: Our review identified knowledge gaps and opportunities in predictive modeling for diarrheal illness, and limitations in existing attempts whilst advancing some precursory thoughts on how to address them, aiming to invigorate future research efforts in this sphere. [ABSTRACT FROM AUTHOR]

Aim: This study evaluated medication poisoning in paediatric patients through a systematic review and a retrospective documentary analysis in a Brazilian toxicological centre. Methods: The data were systematically collected on PubMed, Scopus and SciELO databases following the Preferred Reporting Items for Systematic Reviews and Meta‐Analysis guidelines. We included epidemiologic and prevalence studies that were published in English or Portuguese from 2013 to 2017 and covered paediatric patients. The retrospective incidence study was carried out in a Brazilian toxicological centre and was a documentary analysis of paediatric medication poisoning cases from 2005 to 2015. Results: The systematic review comprised 13 papers covering 895 206 poisoning cases from six different countries. The main agents of intoxication were analgesics and antihistamines. The eight papers that explored the reasons for the poisonings showed that 93% of those 762 863 cases were accidental. The Brazilian toxicological centre recorded 443 paediatric patients poisoned by medication such as benzodiazepines, analgesics and antibiotics and found that 63.2% were accidental. However, it agreed with the global findings in many other aspects. Conclusion: The systematic review showed a sustained number of paediatric medication toxicity cases worldwide and the key findings were broadly reflected by the retrospective study carried out in the Brazilian toxicological centre. [ABSTRACT FROM AUTHOR]

This paper describes the innovative pediatric development strategy of secukinumab in psoriasis. Initially, this pediatric development had been planned early during the adult development program. This is common for most development programs as it is required by law in major regions worldwide. At that time, only limited experience with secukinumab's mechanism of action was available, especially in the pediatric population for which no data had been collected yet. Pediatric extrapolation frameworks were not in use. As a result, a standard pediatric program had initially been proposed requiring two relatively large placebo‐controlled pivotal trials. However, as experience with the use of secukinumab grew, so did experience with—and regulatory openness to—innovative quantitative approaches, such as extrapolation. It became clear that the pediatric development of secukinumab could be substantially accelerated by these novel ideas. Here, we report how these concepts were implemented in the pediatric development program of secukinumab in psoriasis, using a wide range of innovative quantitative techniques. This strategy led to the removal of the placebo arm from one trial, a substantial reduction of the overall sample size in this program, and a significantly faster approval of secukinumab for the pediatric psoriasis population. [ABSTRACT FROM AUTHOR]

Objectives: The severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) virus causes coronavirus disease 2019 (COVID‐19), a respiratory infection that has spread worldwide and is responsible for a high death toll. Although respiratory symptoms are the most common, there is growing evidence that oral signs of COVID‐19 can also be seen in children. The purpose of this systematic review is to provide a comprehensive analysis of the available data on the oral manifestations of COVID‐19 in children and to recommend appropriate methods of diagnosis and treatment. Methods: A systematic search of the MEDLINE, EMBASE, Scopus, and Web of Science databases was done to discover relevant papers published between their establishment and January 2023. Articles detailing oral symptoms in pediatric patients with confirmed COVID‐19 infection were included, and data on clinical characteristics, diagnosis, treatment, and outcomes were extracted and evaluated. Results: A total of 24 studies involving 2112 pediatric patients with COVID‐19 were included in the review. The most common presentations are oral lesions, taste and smell disorders, oral candidiasis, hemorrhagic crust, tongue discoloration, lip and tongue fissuring, gingivitis, and salivary gland inflammation. These manifestations were sometimes associated with multi‐system inflammatory syndrome in children (MIS‐C) or Kawasaki disease (KD). Management strategies varied depending on the severity of the oral manifestation and ranged from symptomatic relief with topical analgesics to systemic medications. Conclusion: Oral symptoms of COVID‐19 are relatively prevalent in juvenile patients and can be accompanied by severe systemic diseases, such as MIS‐C or Kawasaki illness. Early detection and adequate care of these oral symptoms are critical for the best patient results. Understanding the underlying pathophysiology and developing targeted treatments requires more investigation. [ABSTRACT FROM AUTHOR]

Purpose: Three‐dimensional UTE MRI has shown the ability to provide simultaneous structural and functional lung imaging, but it is limited by respiratory motion and relatively low lung parenchyma SNR. The purpose of this paper is to improve this imaging by using a respiratory phase‐resolved reconstruction approach, named motion‐compensated low‐rank reconstruction (MoCoLoR), which directly incorporates motion compensation into a low‐rank constrained reconstruction model for highly efficient use of the acquired data. Theory and Methods: The MoCoLoR reconstruction is formulated as an optimization problem that includes a low‐rank constraint using estimated motion fields to reduce the rank, optimizing over both the motion fields and reconstructed images. The proposed reconstruction along with XD and motion state–weighted motion‐compensation (MostMoCo) methods were applied to 18 lung MRI scans of pediatric and young adult patients. The data sets were acquired under free‐breathing and without sedation with 3D radial UTE sequences in approximately 5 min. After reconstruction, they went through ventilation analyses. Performance across reconstruction regularization and motion‐state parameters were also investigated. Results: The in vivo experiments results showed that MoCoLoR made efficient use of the data, provided higher apparent SNR compared with state‐of‐the‐art XD reconstruction and MostMoCo reconstructions, and yielded high‐quality respiratory phase‐resolved images for ventilation mapping. The method was effective across the range of patients scanned. Conclusion: The motion‐compensated low‐rank regularized reconstruction approach makes efficient use of acquired data and can improve simultaneous structural and functional lung imaging with 3D‐UTE MRI. It enables the scanning of pediatric patients under free‐breathing and without sedation. [ABSTRACT FROM AUTHOR]

In this case series of four paediatric patients, we present the first described cases of immunotherapy‐responsive autoimmune nodopathy with IgG2 antineurofascin antibodies. In three cases, the antineurofascin antibodies were predominantly of the IgG2 subclass, a novel finding in comparison to previously described adult cases where IgG4 and/or IgG1/3 have typically been described. One patient had low signal for IgG2 with predominant IgG1 and IgG4 antibodies, a pattern commonly seen in adult patients. Two patients had antibodies targeting all three neurofascin isoforms (155, 186, and 140), whereas antibodies in the sera from the third targeted only the nodal isoforms 186 and 140, and the fourth patient only neurofascin 155. The three patients with IgG2 predominant antibodies appear to be responsive to intravenous immunoglobulin (IVIG) to varying degrees thus far, whereas the patient with IgG1/4 antibodies had poor response to IVIG but good response to steroids. Although the full clinical significance of IgG2 predominant antineurofascin antibodies in the context of childhood polyneuropathy remains unclear, emerging evidence of serological‐phenotypic correlation may inform prognostication and therapeutic decision‐making, warranting further study into this area. What this paper adds: Paediatric immunotherapy‐responsive nodopathies were associated with antineurofascin antibodies predominantly of the IgG2 subclass in 3 out of 4 patients.Identification of antibodies and understanding their phenotypic relevance could predict response to treatment and guide therapeutic decision‐making in children. [ABSTRACT FROM AUTHOR]

Background: Mild non‐immediate reactions (NIR) to beta‐lactams (βLs) are the most common manifestation of adverse drug reactions in children, and the drug provocation test (DPT) remains the gold standard for diagnosis. However, there are still controversies about the protocol that should be used, especially regarding the administration of doses and the DPT length. Objective: This study aimed to evaluate a pediatric population with a history of mild NIR to amoxicillin (AMX) or to amoxicillin‐clavulanic acid (AMX/CL) who underwent a diagnostic workup including a DPT with the culprit drug, to understand if a graded DPT or, instead, a single full dose could be the most appropriate way of administration in clinical practice. Methods: The data of children were retrospectively analyzed for a 5‐year period, with demographic and clinical characteristics collected. We reported the allergy workup and the results of the DPT performed with the administration of incremental doses and a prolonged DPT at home for a total of 5 days. Results: Three hundred fifty‐four patients were included. Overall, 23/354 (6.5%) DPTs were positive: 11/23 patients showed a reaction after 2–8 h after the last dose on the 1st or 2nd day (1 reacted 30 min after the last dose), 1/23 reacted with urticaria 30 min after the first dose, 11/23 reacted at home on the 5th day of the DPT. Conclusion: This paper indirectly suggests that a single therapeutic dose administered on the 1st day of a DPT could be safe in the diagnostic workup of mild NIR to AMX/CL. Moreover, this could be less time‐consuming as patients would spend less time in the hospital, also considering the public health restrictions imposed during the COVID‐19 pandemic. [ABSTRACT FROM AUTHOR]

This systematic review and meta‐analysis analysed whether pain and disruptive behaviour can be decreased by the use of computerized local dental anaesthesia (CDLA) in children. The literature was screened to select randomized clinical trials that compared computerized and conventional anaesthesia. The primary outcome was pain perception during anaesthesia; the secondary, disruptive behaviour. The risk of bias of individual papers and the quality of the evidence were evaluated. After search, 8389 records were found and 20 studies remained for the qualitative and quantitative syntheses. High heterogeneity was detected for both outcomes. For the pain perception, the overall analysis showed a standard mean difference of −0.78 (−1.31, −0.25) favouring CDLA; however, when only studies at low risk of bias were analysed (subgroup analysis), there was no difference between the two techniques [−0.12(−0.46, 0.22)]. For disruptive behaviour, no differences were detected for continuous [−0.26 (−0.68, 0.16)] or dichotomous data [0.81 (0.62, 1.06)]. The quality of evidence was judged as low for pain perception and very low for disruptive behaviour. It is concluded that there is no difference in the pain perception and disruptive behaviour in children subjected to computerized or conventional dental local anaesthesia. Notwithstanding, the quality of the available evidence is low. [ABSTRACT FROM AUTHOR]

Adeno‐associated virus (AAV) vector‐based gene therapy is an innovative modality being increasingly investigated to treat diseases by modifying or replacing defective genes or expressing therapeutic entities. With its unique anatomic and physiological characteristics, the eye constitutes a very attractive target for gene therapy. Specifically, the ocular space is easily accessible and is generally considered "immune‐privileged" with a low risk of systemic side effects following local drug administration. As retina cells have limited cellular turnover, a one‐time gene delivery has the potential to provide long‐term transgene expression. Despite the initial success with voretigene neparvovec (Luxturna), the first approved retina gene therapy, there are still challenges to be overcome for successful clinical development of these products and scientific questions to be answered. The current review paper aims to integrate published experience learned thus far for AAV‐based retina gene therapy related to preclinical to clinical translation; first‐in‐human dose selection; relevant bioanalytical assays and strategies; clinical development considerations including trial design, biodistribution and vector shedding, immunogenicity, transgene expression, and pediatric populations; opportunities for model‐informed drug development; and regulatory perspectives. The information presented herein is intended to serve as a guide to inform the clinical development strategy for retina gene therapy with a focus on clinical pharmacology. [ABSTRACT FROM AUTHOR]

Aim: To explore the clinical characteristics and prognostic predictors of Guillain–Barré syndrome (GBS) in Chinese paediatric patients. Method: The clinical features of children with GBS hospitalized in the Children's Hospital of Chongqing Medical University were summarized retrospectively. The correlation between the Erasmus GBS Outcome Score (EGOS)/modified Erasmus GBS Outcome Score (mEGOS), GBS disability score (GDS)/modified Rankin Scale (MRS), Erasmus GBS Respiratory Insufficiency Score (EGRIS), and mechanical ventilation were evaluated. Results: One hundred forty‐two patients (86 males, 56 females; median 62.50 months [interquartile range 41.00–97.50]) with classic GBS were enrolled in the study. In the present GBS cohort, 134 (94.37%) patients could walk independently (GDS ≤2) and 121 (85.21%) could manage without assistance (MRS ≤2) at 6 months. Eighteen (12.68%) patients with GBS required mechanical ventilation. The performance of mEGOS on admission, mEGOS on day 7, and EGOS‐predicted GDS outcome at 4 weeks, 3 months, and 6 months in the paediatric patients with GBS admitted within 2 weeks of disease onset and that of the MRS outcome were evaluated. The EGRIS in individuals who required mechanical ventilation was significantly higher than in patients without mechanical ventilation (median = 6 vs median = 3, p < 0.001). Interpretation: In Chinese paediatric patients with GBS who were admitted 2 weeks after disease onset, the mEGOS and EGOS are validated indicators for the prediction of clinical outcomes 6 months after onset. EGRIS is helpful in predicting the implementation of mechanical ventilation in the acute phase. What this paper adds: The Erasmus Guillain–Barré syndrome (GBS) Outcome Score (EGOS) and modified EGOS are reliable prognostic predictors in paediatric patients with GBS.The Erasmus GBS Respiratory Insufficiency Score (EGRIS) is an effective predictor of mechanical ventilation in paediatric patients with GBS.An EGRIS of ≥5 indicates a high risk of mechanical ventilation in the acute phase. [ABSTRACT FROM AUTHOR]

Aim: To explore the breadth of pediatric neurological conditions for which neuromuscular electrical stimulation (NMES) has been studied. Method: Databases (PubMed, Google Scholar, Scopus, and Embase) were searched from 2000 to 2020, using the search terms 'neuromuscular electrical stimulation' OR 'functional electrical stimulation' with at least one of the words 'pediatric OR child OR children OR adolescent', and without the words 'dysphagia OR implanted OR enuresis OR constipation'. Articles focused on adults or individuals with cerebral palsy (CP) were excluded. Results: Thirty‐five studies met the inclusion criteria, with a total of 353 pediatric participants (293 unique participants; mean age 7y 4mo, range 1wk–38y). NMES was applied in a range of pediatric conditions other than CP, including stroke, spinal cord injury, myelomeningocele, scoliosis, congenital clubfoot, obstetric brachial plexus injury, genetic neuromuscular diseases, and other neuromuscular conditions causing weakness. Interpretation: All 35 studies concluded that NMES was well‐tolerated and most studies suggested that NMES could augment traditional therapy methods to improve strength. Outcome measurements were heterogeneous. Further research on NMES with larger, randomized studies will help clarify its potential to improve physiology and mobility in pediatric patients with neuromuscular conditions. What this paper addsNeuromuscular electrical stimulation (NMES) appears to be tolerated by pediatric patients.NMES shows potential for augmenting recovery in pediatric patients with a range of rehabilitation needs. What this paper adds: Neuromuscular electrical stimulation (NMES) appears to be tolerated by pediatric patients.NMES shows potential for augmenting recovery in pediatric patients with a range of rehabilitation needs. [ABSTRACT FROM AUTHOR]

Aim: To investigate the diagnostic yield and treatment impact of whole‐genome sequencing (WGS) in patients with paediatric neurological disorders. Method: From January 2016 to December 2019, paediatric patients who had suspected genetic neurological disorders were assessed using WGS. The phenotypes of eligible patients were divided into four groups: patients with neurodevelopmental disorders; patients with epilepsy; patients with neuromuscular disorders; and patients with movement disorders. Results: A total of 214 consecutive patients (128 males, 86 females) underwent WGS. The mean (SD) age of disease onset was 13.8 (27.6) months (range 1d–15y 5mo). The mean (SD) age at which WGS was performed was 71.7 (58.9) months (range 8d–18y). A molecular diagnosis was reported in 43.9% of patients. The highest diagnostic rate was achieved in 62.5% of patients with neuromuscular disorders, 47.5% of patients with epilepsy, 41.1% of patients with neurodevelopment disorders, and 15.4% of patients with movement disorders. All 94 patients with a WGS diagnosis were given access to genetic counselling and 23.4% of patients had immediate changes in treatment strategies after undergoing WGS. Interpretation: WGS allows paediatric neurologists to integrate genomic data into their diagnosis and adjust management strategies for a range of clinical and genetically heterogeneous disease entities to improve the clinical outcomes of patients. In our cohort, the diagnosis of a significant proportion of patients was reached through WGS (43.9%). Clinicians could use these results to directly guide the management of their patients and improve their clinical outcomes (23.4%). What this paper addsFor selected children in our cohort, the diagnostic yield of whole‐genome sequencing (WGS) was 43.9%.WGS can be used to expand our knowledge of phenotype–genotype variations. What this paper adds: For selected children in our cohort, the diagnostic yield of whole‐genome sequencing (WGS) was 43.9%.WGS can be used to expand our knowledge of phenotype–genotype variations. [ABSTRACT FROM AUTHOR]

Aim: To compare paediatric patients with cerebral sinovenous thrombosis (CSVT) with and without head/neck infection to improve management of the condition. Method: We conducted a bicentric retrospective study of consecutive children (neonates excluded) with radiologically confirmed CSVT, comparing children with a concurrent head/neck infection and children with other causes. Results: A total of 84 consecutive patients (46 males and 38 females) with a median age of 4 years 6 months (range 3 months–17 years 5 months) were included. Associated head/neck infection was identified in 65.4% of cases and represented the main identified CSVT aetiology. Children in the head/neck infection group displayed a milder clinical presentation and less extensive CSVT. Median time to complete recanalization was significantly shorter in this group (89 days [interquartile range 35–101] vs 112.5 days [interquartile range 83–177], p = 0.005). These findings were even more pronounced in the subgroup of patients with otogenic infection and no neurological sign. Interpretation: As CSVT in the setting of an otogenic infection and no neurological sign seems to represent a milder condition with a shorter course, these results suggest adapting current recommendations: consider earlier control imaging in paediatric otogenic CSVT, and shorter anticoagulant treatment if recanalization is obtained. What this paper adds: Children with cerebral sinovenous thrombosis related to head/neck infections have a milder clinical presentation.They also have a shorter recanalization time, especially if there is otogenic infection without neurological symptoms. [ABSTRACT FROM AUTHOR]

Aim: To describe the major congenital anomalies present in children with postneonatally acquired cerebral palsy (CP), and to compare clinical outcomes and cause of postneonatally acquired CP between children with and without anomalies. Method: Data were linked between total population CP and congenital anomaly registers in five European and three Australian regions for children born 1991 to 2009 (n=468 children with postneonatally acquired CP; 255 males, 213 females). Data were pooled and children classified into mutually exclusive categories based on type of congenital anomaly. The proportion of children with congenital anomalies was calculated. Clinical outcomes and cause of postneonatally acquired CP were compared between children with and without anomalies. Results: Major congenital anomalies were reported in 25.6% (95% confidence interval [CI] 21.7–29.9) of children with postneonatally acquired CP. Cardiac anomalies, often severe, were common and present in 14.5% of children with postneonatally acquired CP. Clinical outcomes were not more severe in children with congenital anomalies than those without anomalies. Cause of postneonatally acquired CP differed with the presence of congenital anomalies, with cerebrovascular accidents predominating in the anomaly group. Congenital anomalies were likely associated with cause of postneonatally acquired CP in 77% of children with anomalies. Interpretation: In this large, international study of children with postneonatally acquired CP, congenital anomalies (particularly cardiac anomalies) were common. Future research should determine specific causal pathways to postneonatally acquired CP that include congenital anomalies to identify opportunities for prevention. What this paper adds: One‐quarter of children with postneonatally acquired cerebral palsy (CP) have a major congenital anomaly.Cardiac anomalies, often severe, are the most common anomalies.Causes of postneonatally acquired CP differ between children with and without congenital anomalies. What this paper adds: One‐quarter of children with postneonatally acquired cerebral palsy (CP) have a major congenital anomaly.Cardiac anomalies, often severe, are the most common anomalies.Causes of postneonatally acquired CP differ between children with and without congenital anomalies. [ABSTRACT FROM AUTHOR]

Aim: To describe the frequency and types of major congenital anomalies present in children with pre‐ or perinatally acquired cerebral palsy (CP), and compare clinical outcomes for children with and without anomalies. Method: This multi‐centre total population collaborative study between Surveillance of Cerebral Palsy in Europe, Australian Cerebral Palsy Register, and European Surveillance of Congenital Anomalies (EUROCAT) involved six European and three Australian regions. Data were linked between each region's CP and congenital anomaly register for children born between 1991 and 2009, and then pooled. Children were classified into mutually exclusive categories based on type of anomaly. Proportions of children with congenital anomalies were calculated, and clinical outcomes compared between children with and without anomalies. Results: Of 8201 children with CP, 22.8% (95% confidence interval [CI] 21.9, 23.8) had a major congenital anomaly. Isolated cerebral anomalies were most common (45.2%), with a further 8.6% having both cerebral and non‐cerebral anomalies. Cardiac anomalies only were described in 10.5% of children and anomalies associated with syndromes were also reported: genetic (8.0%), chromosomal (5.7%), and teratogenic (3.0%). Clinical outcomes were more severe for children with CP and congenital anomalies, particularly cerebral anomalies. Interpretation: This large, international study reports major congenital anomalies in nearly one‐quarter of children with pre‐ or perinatally acquired CP. Future research must focus on aetiological pathways to CP that include specific patterns of congenital anomalies. What this paper adds: Congenital anomalies were reported in 23% of children with pre‐ or perinatally acquired cerebral palsy.A higher proportion of children born at or near term had anomalies.The most common type of anomalies were isolated cerebral anomalies.Clinical outcomes were more severe for children with congenital anomalies (particularly cerebral). What this paper adds: Congenital anomalies were reported in 23% of children with pre‐ or perinatally acquired cerebral palsy.A higher proportion of children born at or near term had anomalies.The most common type of anomalies were isolated cerebral anomalies.Clinical outcomes were more severe for children with congenital anomalies (particularly cerebral). This article is commented on by Kirby on pages 366–367 of this issue. [ABSTRACT FROM AUTHOR]

A variety of cognitive, behavioural, and emotional impairments have been reported in the literature that are associated with the resection of the temporal cortex. Klüver–Bucy syndrome is one infrequently reported disorder in the paediatric population. This paper describes the neuropsychological findings of a female paediatric patient at 7 and 10 years of age with a diagnosis of partial Klüver–Bucy syndrome (pKBS) following total resection of the amygdala and right hippocampus to resect a glioma. The patient presented emotional problems, aggressiveness, hypermetamorphosis, social indifference, and behavioural dysexecutive syndrome, which was found at both 7 and 10 years, but with a decrease in the severity of alterations in attention, impulsivity, hyperactivity, and aggressive behaviour in a second evaluation after she had a neuropsychological intervention. These findings describe the neuropsychological profile of paediatric case with resection of the amygdala and right temporal lobe. [ABSTRACT FROM AUTHOR]

Background: Adolescence is a developmental period that is known for the highest risk of difficulties with adoption and maintenance of health behaviors for successful transplant. Motivational interviewing (MI) has been demonstrated to be an effective strategy in the management of modifiable factors impacting adherence in both adult transplant and analogous pediatric chronic illness populations. Aims: This paper describes MI and its applicability to adolescent transplant, providing examples of its potential use at each stage of the transplant journey. Materials and Methods: Literature on the principles and utilization of MI are reviewed, as well as the use of MI in adult transplant and similar pediatric populations. Results: Evidence suggests high applicability of concepts of MI to pediatric transplant. Discussion: Systems‐level factors influencing health behavior change are discussed, along with the importance of recognizing and managing provider bias in MI‐based interactions. MI does not require a licensed behavioral health provider to use it effectively; rather, it can be used by various multidisciplinary team members throughout the course of clinical care. Conclusion: MI shows great promise as a useful intervention through all stages in the transplant journey. Though particularly well‐suited to adolescents, its principles are effective across the lifespan, including with caregivers. It represents an interactional style for use by multidisciplinary team members in many patient‐and caregiver‐facing scenarios. As the goal is to support the patient's autonomy in decision‐making, it is important for providers to recognize their own biases. Further resources for training are provided. [ABSTRACT FROM AUTHOR]

Although pediatric growth curves provide clinical utility, using these metrics for within‐person change over time can be misleading. As research is focused on understanding cardiometabolic consequences of weight gain, it is important to use precise metrics to analyze these longitudinal research questions. Despite several foundational recommendations to limit the use of reference pediatric growth curves (e.g., BMI z scores) for within‐person longitudinal research, it has evolved into the "gold standard" for using growth curves for pediatric weight gain analyses. Therefore, the objective of this paper is to discuss (A) the methodology used to create reference growth curves; (B) the appropriate use of reference pediatric BMI growth curves within the context of cross‐sectional and longitudinal analyses in research; and (C) how to select metrics based on desired evaluations. Careful consideration using standardized references scores is essential when assessing obesity‐related questions and comorbid risk over time in pediatric populations. [ABSTRACT FROM AUTHOR]

Irritant diaper dermatitis is a common dermatologic problem among infants and young children. Severe erosive presentations, although uncommon, are diagnostically challenging and can mimic non‐accidental trauma (NAT). Diagnosing inflicted injury and NAT where it does not exist can cause parental distress, yet failing to diagnose inflicted injury and NAT can result in re‐injury. We describe three cases of severe erosive diaper dermatitis in pediatric patients aged 2–6 years that were initially concerning for inflicted scald burn or neglect. [ABSTRACT FROM AUTHOR]

Objectives: The therapeutic alliance (TA) has been shown to be a predictor of psychotherapy treatment success. In the case of psychotherapy with children, there is a dearth of information on TA's role. The aims of the paper are: (1) To estimate the therapist effects on children TA; (2) to investigate if therapists' TA predicts children's TA; (3) to analyze if children's age and sex predict children's TA; (4) to evaluate if the therapist's characteristics predict children's TA. Methods: The sample consisted of 77 children undergoing psychotherapy in Argentina, and the therapists (N = 29) providing services to those children. The assessment tools utilized for the study included the Therapy Alliance Scale for Children and the Personal Style of the Therapist Questionnaire (PST‐Q). Results: Findings indicated that 2% of the children's TA was explained by the therapists (ICC = 0.02), while 17% of the therapists' TA was explained by the therapists (ICC = 0.17). Therapists' TA predicted children's TA. Children's age and sex did not have an effect on their own TA. Moreover, therapists with more experience achieved higher scores of children's TA. Finally, the Operative dimension of the PST had a negative effect on children's TA (i.e., therapists who prefer more spontaneous interventions over structured ones may experience higher levels of therapeutic alliance with child patients). Conclusion: We found a positive effect of the therapist's TA on children's TA, especially in the preference for using more spontaneous intervention techniques. We discuss the implications of the findings on the training of psychotherapists who provide services to children. [ABSTRACT FROM AUTHOR]

Importance: Optical coherence tomography (OCT) is a high‐resolution intravascular imaging tool and has shown promise for providing real‐time quantitative and qualitative descriptions of pulmonary vascular structures in vivo in adult pulmonary hypertension (PH), while not popular in pediatric patients with congenital heart diseases (CHD). Objective: The aim of this review is to summarize all the available evidence on the use of OCT for imaging pulmonary vascular remodeling in pediatric patients. Methods: We conducted the systematic literature resources (Cochran Library database, Medline via PubMed, EMBASE, and Web of Knowledge) from January 2010 to December 2021 and the search terms were "PH", "child", "children", "pediatric", "OCT", "CHD", "pulmonary vessels", "pulmonary artery wall". Studies in which OCT was used to image the pulmonary vessels in pediatric patients with CHD were considered for inclusion. Results: Five studies met the inclusion criteria. These five papers discussed the study of OCT in the pulmonary vasculature of different types of CHD, including common simple CHD, complex cyanotic CHD, and Williams‐Beuren syndrome. In biventricular anatomy, pulmonary vascular remodeling was primarily reflected by pulmonary intima thickening from two‐dimensional OCT. In single‐ventricle anatomy, due to the state of hypoxia, the morphology of pulmonary vessels was indirectly reflected by the number and shape of nourishing vessels from three‐dimensional OCT. Interpretation: OCT may be an adequate imaging procedure for the demonstration of pulmonary vascular structures and provide additional information in pediatric patients. [ABSTRACT FROM AUTHOR]

Background: Tofacitinib, a potent JAK inhibitor, has gained increasing interest, in recent years, among dermatologists for the management of refractory alopecia areata. Despite a growing number of studies on its safety and efficacy, there is still a lack of clarity, especially in the pediatric population, in treatment considerations such as proper dosage, treatment duration, side‐effect profile, and therapeutic strategies to guide clinicians. Methods: Multiple databases were systematically searched. Following the PRISMA diagram, of a pool of 601 papers, seven met a checklist of inclusion criteria. These were observational studies including a total of 59 patients from four to 19 years of age. Results: In the evaluated studies, tofacitinib was administered either orally at a 2.5 to 15 mg daily (mostly 5 mg twice a day) dosage for 2 to 38 months or in the form of a 2% topical solution for 3–17 months. Metanalysis showed that 49% (95% CI: 29%–69%, I2 = 59.94%) of patients experienced a reversal of alopecia after a minimum of 3 to 9 months of therapy. Fifty‐five percent (95% CI: 23%–86%, I2 = 75.07%) and 41% (95% CI: 23%–59%, I2 = 0.00%) showed Good/complete and partial response rates, respectively. Oral administration was significantly more efficacious than topical application (73% vs 23%, p‐Value = 0.04). Few side effects such as diarrhea and mild liver transaminases abnormalities were noted in several patients. Conclusion: Results of this review suggest that tofacitinib at 2.5–15 mg daily (especially 5 mg twice daily) oral formulation or 2% topical solution can be regarded as a viable alternative or adjunct to the conventional treatment options for moderate to severe forms of alopecia areata in children owing to its acceptable efficacy and side‐effect profile. However, uncertainties continue to exist around treatment strategies including initial and maintenance dosages, route of administration, dose adjustments, the timing of tapering or discontinuation, and associated treatment modalities. [ABSTRACT FROM AUTHOR]

Cerebral near infrared spectroscopy (NIRS) monitoring has been extensively applied in neonatology and in cardiac surgery, becoming a standard in many pediatric cardiac centers. However, compensatory physiological mechanisms favor cerebral perfusion to the detriment of peripheral tissue oxygenation. Therefore, simultaneous measurement of cerebral and somatic oxygen saturation has been advocated to ease the differential diagnosis between central and peripheral sources of hypoperfusion, which may go undetected by standard monitoring and not mirrored by cerebral NIRS alone. A clinical algorithm already exists in cardiac surgery, aimed to correct intraoperative cerebral oxygen desaturations. A similar algorithm still lacks in noncardiac pediatric surgery. The goal of this paper is to propose a clinical algorithm for the combined use of cerebral and somatic NIRS monitoring during anesthesia in the pediatric population undergoing noncardiac surgery. A panel of experienced pediatric anesthetists developed the algorithm that is based on the clinical experience and intraoperative observations. It aims to lessen the current variability in interpreting NIRS measurement. Multisite NIRS monitoring was achieved applying one pediatric sensor to the forehead for cerebral tissue perfusion reading and a second one to the decumbent lumbar region for recording somatic renal tissue perfusion. The algorithm describes a sequence of acts aimed to identify the putative cause of intraoperative organ tissue desaturation and suggests clinical interventions expected to restore adequate tissue perfusion. It is composed of two arms: the main arm includes patients with an observed decrease in cerebral perfusion (CrO2), the second one includes those with a stable CrSO2 with declining RrSO2. Described also are five clinical cases of infants and neonates in whom pathological alterations of organ perfusion were detected using intraoperative multisite NIRS monitoring, portrayed in the accompanying figures (Annex). [ABSTRACT FROM AUTHOR]

Crohn's disease (CD) is a complex multisystemic inflammatory disorder and part of the inflammatory bowel diseases (IBDs). About 20% of the subjects affected by IBDs are paediatric patients and 21% of them present extraintestinal manifestations. Among the extraintestinal manifestations of CD, oral manifestations are rather frequent (20–50% of affected people) and can be difficult to identify, being frequently aspecific and not pathognomonic. Their early diagnosis by the dentist is extremely important, because extraintestinal manifestations can precede intestinal symptoms, in all patients but especially in children. The aim of this paper is to report the case of a CD adolescent patient that presented a gingival manifestation. [ABSTRACT FROM AUTHOR]

Introduction: Globally about 1.7 million children were living with HIV in 2020. Two integrase strand transfer inhibitors, dolutegravir and raltegravir, are increasingly used in children. We conducted a systematic review to assess the effectiveness and safety of dolutegravir and raltegravir in children and adolescents living with HIV, aged 0–19 years. Methods: Sources included MEDLINE, Embase, the Cochrane Library, clinical trial registries, abstracts from key conferences and reference list searching. Observational studies and clinical trials published January 2009–March 2021 were eligible. Outcomes included efficacy/effectiveness (CD4 counts and viral load) and/or safety outcomes (mortality, grade 3/4 adverse events and treatment discontinuation) through 6 months or more post‐treatment initiation. Risk of bias was assessed using previously published tools appropriate for the study design. Narrative syntheses were conducted. Results and discussion: In total, 3626 abstracts and 371 papers were screened. Eleven studies, including 2330 children/adolescents, reported data on dolutegravir: one randomized controlled trial (RCT; low risk of bias), one single‐arm trial (unclear risk of bias) and nine cohort studies (three low risk of bias, two unclear risk and four high risk). Ten studies, including 649 children/adolescents receiving raltegravir, were identified: one RCT (low risk of bias), one single‐arm trial (low risk of bias) and eight cohort studies (four low risk of bias, three unclear risk and one high risk). Viral suppression levels in children/adolescents at 12 months were high (>70%) in most studies assessing dolutegravir (mostly second‐ or subsequent‐line, or mixed treatment lines), and varied from 42% (5/12) to 83% (44/53) at 12 months in studies assessing raltegravir (mostly second‐ or subsequent‐line). Across all studies assessing dolutegravir or raltegravir, grade 3/4 adverse events (clinical and/or laboratory) were reported in 0–50% of subjects, few resulted in discontinuation, few were drug related and no deaths were attributed to either drug. Conclusions: These reassuring findings suggest that dolutegravir and raltegravir are effective and safe as preferred regimens in children and adolescents living with HIV. With the rollout of dolutegravir in paediatric populations already underway, it is critical that data are collected on safety and effectiveness in infants, children and adolescents, including on longer‐term outcomes, such as weight and metabolic changes. [ABSTRACT FROM AUTHOR]

Background: The role of patient educational materials for paediatric patients is increasing. A reading grade level of eighth‐grade (USA) or year nine (Australia and New Zealand) is recommended as acceptable. The aim of this paper was to assess the reading grade levels of paediatric online patient educational materials, within Australasia. Methods: The online Google® search engine was used with a variety of keyword combinations, filtered to the location of Australia and New Zealand. Suitable websites were explored for webpages related to slipped upper femoral epiphysis, septic arthritis, osteomyelitis, talipes equinovarus and developmental dysplasia of the hip. Readability was assessed using the online readability software WEB FX®. Results: Seventy‐six patient educational webpages were analysed: 66 from Australia and 10 from New Zealand. Only eight of the 76 webpages (10.5%) had reading grade levels below the recommended eighth‐grade (US)/year nine (AUS/NZ) level. Webpages from private healthcare providers and pages related to septic arthritis had the significantly highest reading grades. Conclusions: Australasian families have limited online patient educational materials available to them, which are mostly set at reading grade levels above recommended standards. Healthcare providers should be incentivized to improve the readability of their patient educational materials to reduce health disparities and improve health literacy moving forward. [ABSTRACT FROM AUTHOR]

Pharmacogenomics (PGx) relates to the study of genetic factors determining variability in drug response. Implementing PGx testing in paediatric patients can enhance drug safety, helping to improve drug efficacy or reduce the risk of toxicity. Despite its clinical relevance, the implementation of PGx testing in paediatric practice to date has been variable and limited. As with most paediatric pharmacological studies, there are well‐recognised barriers to obtaining high‐quality PGx evidence, particularly when patient numbers may be small, and off‐label or unlicensed prescribing remains widespread. Furthermore, trials enrolling small numbers of children can rarely, in isolation, provide sufficient PGx evidence to change clinical practice, so extrapolation from larger PGx studies in adult patients, where scientifically sound, is essential. This review paper discusses the relevance of PGx to paediatrics and considers implementation strategies from a child health perspective. Examples are provided from Canada, the Netherlands and the UK, with consideration of the different healthcare systems and their distinct approaches to implementation, followed by future recommendations based on these cumulative experiences. Improving the evidence base demonstrating the clinical utility and cost‐effectiveness of paediatric PGx testing will be critical to drive implementation forwards. International, interdisciplinary collaborations will enhance paediatric data collation, interpretation and evidence curation, while also supporting dedicated paediatric PGx educational initiatives. PGx consortia and paediatric clinical research networks will continue to play a central role in the streamlined development of effective PGx implementation strategies to help optimise paediatric pharmacotherapy. [ABSTRACT FROM AUTHOR]

The US Food and Drug Administration (FDA) has concluded that the efficacy of drugs approved for the treatment of partial onset seizures (POS) in adults can be extrapolated to pediatric patients 1 month of age and above and that independent efficacy trials in this pediatric population are no longer needed. This paper focuses on the dosing, pharmacokinetic (PK), exposure‐response, and clinical information that were leveraged from the approved drugs for the treatment of POS to conduct analyses that supported extrapolation of efficacy in pediatric patients. Clinical data from trials for eight drugs (levetiracetam, oxcarbazepine, topiramate, lamotrigine, gabapentin, perampanel, tiagabine, and vigabatrin) approved in both adults and pediatric patients for the treatment of POS were analyzed. Comparisons of exposures at approved doses, placebo response, and model‐based exposure‐response relationships were performed. Based on disease similarity, similar response to intervention, and similar exposure‐response relationships in adults and pediatric patients, it was concluded that extrapolation of efficacy in pediatric patients aged 1 month and above is acceptable. PK analysis to determine pediatric dose and regimens that provide drug exposure similar to that known to be effective in adult patients with POS will be required, along with long‐term open‐label safety data in pediatric patients. [ABSTRACT FROM AUTHOR]

Traditional orthopedic casting strategies used in the treatment of fractured limbs, such as fiberglass and plaster‐based tapes, suffer from several drawbacks, including technically challenging molding for application, occurrence of skin complications, and the requirement of a potentially hazardous oscillatory saw for removal, which is frightening for pediatric patients. This work presents the design and evaluation of a foam‐fabric cast (FFC) to overcome these drawbacks by integrating strategies from soft materials engineering and functional apparel design. A fabric sleeve is designed to enable the reactive injection molding of a polymer foam and provide a form‐fitting orthopedic cast for the human forearm—with sufficient mechanical reinforcement to stabilize a fractured limb. Through testing with a replica limb and human subjects with a range of forearm volumes, the FFC application process is demonstrated and characterized. The thermal, pressural, chemical, and hygienic safety are comparable to or safer than existing clinical technologies. The FFC weighs only ≈150 g, is water resistant, and represents a robust alternative to traditional casts that can be i) manufactured at a large scale for a low cost; ii) applied to patients simply, rapidly (≈5 min), and reliably; and iii) removed easily with a pair of scissors. [ABSTRACT FROM AUTHOR]

Background: Supracondylar fractures are the most common elbow fracture. There have been no studies published analysing flexion‐type fractures in the Australian paediatric population. This paper aims to investigate flexion‐type supracondylar fractures in an Australian paediatric population. Eight hundred and three paediatric supracondylar elbow fractures were retrospectively reviewed at one hospital over a 5 year time period. The focus was on flexion‐type fractures. Methods: Supracondylar fractures that presented to the Women's and Children's Hospital Emergency Department between 2015 and 2020 were retrospectively reviewed. Fractures were classified on plain radiographs according to the Modified Gartland Classification System. Injury and treatment data were collected for flexion‐type fractures. Results: Twenty‐one (2.6%) of fractures were flexion‐type. The average age of injury was 6.8 years old. Flexion‐type fractures were more common in females (62%) and with high energy mechanisms (81%). Ulnar nerve palsies occurred in five cases (24%). Two ulna nerve palsies did completely resolve at 3 months follow up. One open fracture occurred. No vascular injuries occurred. Ten of the 21 flexion‐type fractures (48%) were treated surgically. Conclusions: The authors conclude that: flexion fractures are uncommon, they occur more often after high energy mechanisms such as falls from monkey bars, swings, or trampolines. Flexion‐type fractures occur more often in slightly older females. The ulnar nerve is most frequently injured and in the current study—exclusively injured. At 3 month follow up, spontaneous nerve recovery had occurred in three of the five cases (60%). [ABSTRACT FROM AUTHOR]

Current guidelines support the use of continuous glucose monitoring devices and insulin pumps in minor surgical procedures for pediatric patients with type 1 diabetes mellitus. However, there are few reported cases of using hybrid closed loop technology in the perioperative period. This retrospective case series presents seven pediatric patients with type 1 diabetes who underwent eight surgical procedures with maintenance of hybrid closed loop systems. This paper also provides considerations for future use of hybrid closed loop systems perioperatively. [ABSTRACT FROM AUTHOR]

Summary: Since its first description by Evans in 1951, this syndrome has been linked to chronic immune thrombocytopenia with the concurrent or delayed onset of autoimmune haemolytic anaemia or neutropenia. For decades, the evolution of Evans syndrome (ES) has carried a poor prognosis and often resulted in chronic steroid exposure, multiple immune suppressing medications directed against T or B lymphocytes, and splenectomy. This paper presents a new view of ES based on recent advances in genomics which begin to classify patients based on their underlying molecular variants in previously described primary immune disorders. This has opened up new avenues of targeted therapy or bone marrow transplant at rather than broad long‐term immune suppression or splenectomy. Importantly, recent studies of the full lifespan of ES suggest that at least 80% of those paediatric patients will progress to various clinical or biological immunopathological manifestations with age despite the resolution of their cytopenias. Those patients merit long‐term follow‐up and monitoring in dedicated transition programs to improve outcome at the adult age. [ABSTRACT FROM AUTHOR]

Purpose: Organ autosegmentation efforts to date have largely been focused on adult populations, due to limited availability of pediatric training data. Pediatric patients may present additional challenges for organ segmentation. This paper describes a dataset of 359 pediatric chest‐abdomen‐pelvis and abdomen‐pelvis Computed Tomography (CT) images with expert contours of up to 29 anatomical organ structures to aid in the evaluation and development of autosegmentation algorithms for pediatric CT imaging. Acquisition and validation methods: The dataset collection consists of axial CT images in Digital Imaging and Communications in Medicine (DICOM) format of 180 male and 179 female pediatric chest‐abdomen‐pelvis or abdomen‐pelvis exams acquired from one of three CT scanners at Children's Wisconsin. The datasets represent random pediatric cases based upon routine clinical indications. Subjects ranged in age from 5 days to 16 years, with a mean age of 7 years. The CT acquisition, contrast, and reconstruction protocols varied across the scanner models and patients, with specifications available in the DICOM headers. Expert contours were manually labeled for up to 29 organ structures per subject. Not all contours are available for all subjects, due to limited field of view or unreliable contouring due to high noise. Data format and usage notes: The data are available on The Cancer Imaging Archive (TCIA_ (https://www.cancerimagingarchive.net/) under the collection Pediatric‐CT‐SEG. The axial CT image slices for each subject are available in DICOM format. The expert contours are stored in a single DICOM RTSTRUCT file for each subject. The contour names are listed in Table 2. Potential applications: This dataset will enable the evaluation and development of organ autosegmentation algorithms for pediatric populations, which exhibit variations in organ shape and size across age. Automated organ segmentation from CT images has numerous applications including radiation therapy, diagnostic tasks, surgical planning, and patient‐specific organ dose estimation. [ABSTRACT FROM AUTHOR]

Increasing prevalence of infections caused by antimicrobial‐resistant gram‐negative bacteria represents a global health crisis, and while several novel therapies that target various aspects of antimicrobial resistance have been introduced in recent years, few are currently approved for children. Ceftazidime‐avibactam is a novel β‐lactam β‐lactamase inhibitor combination approved for adults and children 3 months and older with complicated intra‐abdominal infection, and complicated urinary tract infection or hospital‐acquired ventilator‐associated pneumonia (adults only in the United States) caused by susceptible gram‐negative bacteria. Extensive population pharmacokinetic (PK) data sets for ceftazidime and avibactam obtained during the adult clinical development program were used to iteratively select, modify, and validate the approved adult dosage regimen (2,000–500 mg by 2‐hour intravenous (IV) infusion every 8 hours (q8h), with adjustments for renal function). Following the completion of one phase I (NCT01893346) and two phase II ceftazidime‐avibactam studies (NCT02475733 and NCT02497781) in children, adult PK data sets were updated with pediatric PK data. This paper describes the development of updated combined adult and pediatric population PK models and their application in characterizing the population PK of ceftazidime and avibactam in children, and in dose selection for further pediatric evaluation. The updated models supported the approval of ceftazidime‐avibactam pediatric dosage regimens (all by 2‐hour IV infusion) of 50–12.5 mg/kg (maximum 2,000–500 mg) q8h for those ≥6 months to 18 years old, and 40–10 mg/kg q8h for those ≥3 to 6 months old with creatinine clearance > 50 mL/min/1.73 m2. [ABSTRACT FROM AUTHOR]

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News in medicine has an obligation to be helpful, accurate, comprehensible for the intended audience and part of an on-going professional relationship that enables the best outcomes available. These obligations have special poignancy when the news is bad, the patient is a child and the news scene is a busy medical practice, clinic or hospital. This paper aims to outline specific ways of being helpful when delivering bad news, within the constraints of daily practice, to a wide variety of developmentally different children at different stages in the family life cycle. The paper specifies the purpose, tasks, obstacles and practicalities of giving adverse information about the health of children in our clinical work. Adverse news needs to be embedded within delivering news more generally in our work. This presupposes a trusting relationship, an accurate understanding of the news to be delivered and a capacity to communicate medical complexity to the intended audience. There are multiple audiences for our medical news, at different developmental stages, each of whom needs help to 'hear the news' in different ways. Each developmental period within a broader family life cycle is briefly addressed. The limited evidence-base is outlined with a view to what the clinician can do to foster maximal support, understanding and on-going cooperation. The interplay between realism and optimism is highlighted so that accuracy and helpfulness are wedded as meaningfully and sensitively as possible. The aim is to be helpful rather than pursue an ideal of the unfaltering, polished and flawlessly performing clinician. [ABSTRACT FROM AUTHOR]

When parents ask doctors not to disclose certain information to a child, doctors are challenged to articulate ethical reasons for giving information to children. This paper maps out the professional and legal landscape in which information-giving to children is taking place and identifies the key ethical arguments that have been made for disclosure of information to the child patient. We focus on pre-adolescent children, who have not reached a developmental stage that would see them regarded as 'mature minors'. While doctors can be relatively certain that professional and legal requirements will endorse their disclosure of information to the 'mature minor', guidelines are not clear on information-giving to pre-adolescents (immature minors). We identify six ethical reasons for telling the truth to younger children. It is noteworthy that there are good reasons to tell the truth to children, which are independent of any question of the child's capacity to be involved in decision-making. [ABSTRACT FROM AUTHOR]

Nail pigmentation in children can cause significant anxiety in parents and clinicians. Different pigments of the nails, such as yellow, orange, and green, can all occur; however, this paper will focus on the dark pigments: brown, gray, and black pigmentation of the nails. Many causes of dark coloration of the nails exist; almost all causes in pediatric patients are benign and require no treatment. Melanoma is the one diagnosis that physicians do not want to miss. Fortunately, this is extremely rare in children. [ABSTRACT FROM AUTHOR]

Gastrointestinal endoscopy is fundamental to diagnostic and therapeutic procedures in pediatric gastroenterology. In the decades since endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) for hepatobiliary and pancreatic disease were introduced into clinical practice, there has been increasing interest in these procedures, and practice guidelines and position papers that clearly define the role of ERCP and EUS in children have been published. Based on the distinction of endoscopy between children and adults, this review focuses on the current state of ERCP and EUS procedures in children, including the types of endoscopes used in children, general anesthesia and radiation exposure, biliary and pancreatic indications, considerations of education and training for ERCP and EUS procedures in children, and expectations for development of endoscopes for children. [ABSTRACT FROM AUTHOR]

Introduction: Social Workers (SWs) provide valuable services on multidisciplinary teams of Haemophilia Treatment Centres (HTCs). However, their roles have not been defined and standardized. This paper identifies six major SW roles, including counselling, case management, financial/insurance, outreach/programs, administrative, and grants/research. Roles were further classified as 'actual' roles, those that SWs were actively practicing, and 'ideal' roles, those that SWs felt were most important for their clients. Aim: The goal of this study was to determine the actual and ideal roles of HTC SWs and the barriers to ideal roles. Methods: An online survey was tested with a focus group and then e‐mailed to 147 SWs who were working in the 141 HTCs across the United States. Results: Fifty‐five percent of the SWs completed the survey. Data revealed that SWs' most prominent actual role was case management in their work with three client sub‐populations: adult patients, paediatric patients and family members. However, SWs identified counselling as the ideal role that was most important for all client groups. Barriers to practicing ideal roles included lack of SW input, insufficient budgeted time and inadequate training. Salaries were found to be stagnant compared to 2010. Twenty‐five percent of SWs reported no supervision. Conclusions: Survey results gave evidence that although HTC SWs were primarily engaged in case management roles, they wanted to take on larger counselling roles. Efforts should be made to eliminate barriers to ideal SW roles so that SWs can provide additional psychosocial services for HTC patients. [ABSTRACT FROM AUTHOR]

Living‐donor kidney transplantation is the first choice therapy for children with end‐stage renal disease and shows good long‐term outcome. Etiology of renal failure, co‐morbidities, and hemodynamic effects, due to donor‐recipient size mismatch, differs significantly from those in adult patients. Despite the complexities related to both patient and surgery, there is a lack of evidence‐based anesthesia guidelines for pediatric kidney transplantation. This educational review summarizes the pathophysiological changes to consider and suggests recommendations for perioperative anesthesia care, based on recent research papers. [ABSTRACT FROM AUTHOR]