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Keywords = pediatric safety assessment

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9 pages, 351 KiB  
Article
Button Cystostomy in Children with Neurogenic Bladder: Outcomes from a Single Center
by Michela Galati, Rebecca Pulvirenti, Ida Barretta, Noemi Deanesi, Chiara Pellegrino, Antonio Maria Zaccara, Maria Luisa Capitanucci and Giovanni Mosiello
J. Clin. Med. 2025, 14(15), 5532; https://doi.org/10.3390/jcm14155532 - 6 Aug 2025
Abstract
Background: Neurogenic bladder (NB) in children may lead to recurrent urinary tract infections (UTIs), renal deterioration, and a reduced quality of life. Clean intermittent catheterization (CIC) is the standard of care, but in some patients, CIC may be unfeasible due to anatomical, [...] Read more.
Background: Neurogenic bladder (NB) in children may lead to recurrent urinary tract infections (UTIs), renal deterioration, and a reduced quality of life. Clean intermittent catheterization (CIC) is the standard of care, but in some patients, CIC may be unfeasible due to anatomical, sensory, or compliance issues. Button cystostomy (BC) has emerged as a minimally invasive, bladder-preserving alternative. This study aimed to assess the feasibility, safety, and outcomes in the long-term of BC in pediatric NB patients. Methods: Retrospective analysis was conducted on children with NB who underwent endoscopic BC placement between January 2020 and December 2024 in a tertiary pediatric center. Demographic data, operative time, complications, and follow-up outcomes were collected. All procedures used an endoscopic approach with cystoscopic guidance for safe device placement. Results: Thirty-three patients (25 males; median age 7.96 years) underwent BC placement. Most had spinal dysraphism (63.6%). The mean operative time was 48.5 ± 6 min. During a mean follow-up of 2.1 ± 1.4 years, five patients (15.2%) had febrile UTIs and two had minor leakage. No major complications occurred. Four buttons were removed due to clinical improvement (N = 1), the fashioning of a continent derivation (N = 1) and implantation of a sacral neuromodulator (N = 2); two patients accepted CIC. Satisfaction was reported by 93.9% of families. Conclusions: BC is an effective, minimally invasive alternative for urinary drainage in children with NB, even when compared to continent diversion techniques such as the Mitrofanoff, due to its lower invasiveness, greater feasibility, and lower complication rate. Broader adoption may be warranted, but prospective studies are needed to confirm long-term outcomes. Full article
(This article belongs to the Special Issue Recent Advances in Reconstructive Urology and Prosthetic Surgery)
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13 pages, 2893 KiB  
Article
Vaccine Attitudes, Knowledge, and Confidence Among Nursing, Pediatric Nursing, and Midwifery Undergraduate Students in Italy
by Ersilia Buonomo, Daniele Di Giovanni, Gaia Piunno, Stefania Moramarco, Giuliana D’Elpidio, Ercole Vellone, Enkeleda Gjini, Mariachiara Carestia, Cristiana Ferrari and Luca Coppeta
Vaccines 2025, 13(8), 813; https://doi.org/10.3390/vaccines13080813 - 30 Jul 2025
Viewed by 200
Abstract
Background: Vaccine hesitancy (VH) represents a growing concern among healthcare professionals and students, potentially undermining public health efforts. Nursing, pediatric nursing, and midwifery students are future vaccinators and educators, making it essential to understand their attitudes, knowledge, and confidence toward vaccination. This study [...] Read more.
Background: Vaccine hesitancy (VH) represents a growing concern among healthcare professionals and students, potentially undermining public health efforts. Nursing, pediatric nursing, and midwifery students are future vaccinators and educators, making it essential to understand their attitudes, knowledge, and confidence toward vaccination. This study aims to assess vaccine-related perceptions and behaviors among these student populations in an Italian university. Methods: A cross-sectional survey was conducted between November 2022 and February 2024 at the University of Rome “Tor Vergata”. A structured, anonymous questionnaire, including the Vaccination Attitudes Examination (VAX) scale, vaccine knowledge items, and sources of information, was administered to students in nursing (n = 205), pediatric nursing (n = 46), and midwifery (n = 21). Statistical analyses included descriptive statistics, ANOVA, post hoc tests, and Mann–Whitney U tests. Results: Among the 272 participants, 20.6% reported refusing at least one recommended vaccine, and 18.4% delayed vaccination for non-medical reasons. Vaccine knowledge and confidence increased significantly with academic progression (p < 0.001). Midwifery students showed both the highest concern for long-term vaccine effects and the greatest confidence in vaccine safety. Institutional and scientific sources were the most trusted, though traditional and non-institutional media also influenced perceptions, particularly among midwifery students. Conclusions: Despite high COVID-19 vaccine uptake, VH persists among health professional students. Discipline-specific patterns highlight the need for early, targeted educational strategies to enhance vaccine literacy and reduce hesitancy. Tailored training may empower future professionals to become informed and credible advocates for vaccination. Full article
(This article belongs to the Special Issue Acceptance and Hesitancy in Vaccine Uptake: 2nd Edition)
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14 pages, 228 KiB  
Article
Impact of Japan’s 2024 Physician Work Style Reform on Pediatricians’ Working Hours and Associated Factors
by Masatoshi Ishikawa, Ryoma Seto, Michiko Oguro and Yoshino Sato
Healthcare 2025, 13(15), 1815; https://doi.org/10.3390/healthcare13151815 - 25 Jul 2025
Viewed by 257
Abstract
Background/Objectives: Long working hours among pediatricians negatively affect their health and patient safety. In Japan, the Ministry of Health, Labour and Welfare launched the “Work Style Reform for Physicians” in 2024. However, whether these reforms have effectively reduced pediatricians’ working hours remains unclear. [...] Read more.
Background/Objectives: Long working hours among pediatricians negatively affect their health and patient safety. In Japan, the Ministry of Health, Labour and Welfare launched the “Work Style Reform for Physicians” in 2024. However, whether these reforms have effectively reduced pediatricians’ working hours remains unclear. We surveyed pediatricians and pediatric residents working in hospital pediatric departments to assess whether the reform has reduced their long working hours. Methods: A questionnaire was distributed to pediatricians in hospitals, collecting data on demographics, working hours, night shifts, and other working conditions. A multivariate logistic regression analysis identified factors associated with working ≥60 and ≥80 h on a weekly basis. Results: Questionnaires were sent to 835 hospitals, with valid responses from 815 pediatricians across 316 hospitals. Among them, 31.7% worked 50–60 h per week, 18.4% worked 60–70 h, 7.7% worked 70–80 h, and 4.9% worked >80 h. Factors associated with working >60 h included being <30 years old and working in a department with five or more physicians. Pediatricians working >80 h were more likely to have a cardiology subspecialty and work in a department with five or more physicians. Conclusions: Although the “Work Style Reform for Physicians” has reduced long working hours among pediatricians, many still experience excessive workloads. Full article
(This article belongs to the Special Issue Job Satisfaction and Mental Health of Workers: Second Edition)
13 pages, 407 KiB  
Systematic Review
Peripheral Vascular Access in Infants: Is Ultrasound-Guided Cannulation More Effective than the Conventional Approach? A Systematic Review
by Cristina Casal-Guisande, Esperanza López-Domene, Silvia Fernández-Antorrena, Alberto Fernández-García, María Torres-Durán, Manuel Casal-Guisande and Alberto Fernández-Villar
Medicina 2025, 61(8), 1321; https://doi.org/10.3390/medicina61081321 - 22 Jul 2025
Viewed by 289
Abstract
Background and Objectives: Peripheral vascular access in infants is a frequent but technically challenging procedure due to the anatomical characteristics of this population. Repeated failed attempts may increase complications and emotional stress for both patients and healthcare professionals. This systematic review aimed [...] Read more.
Background and Objectives: Peripheral vascular access in infants is a frequent but technically challenging procedure due to the anatomical characteristics of this population. Repeated failed attempts may increase complications and emotional stress for both patients and healthcare professionals. This systematic review aimed to evaluate the efficacy and safety of ultrasound-guided peripheral vascular cannulation compared to the conventional or “blind” technique in infants. Materials and Methods: A systematic review was conducted in accordance with PRISMA guidelines. The PubMed database was searched for studies published between 2017 and 2025. Studies comparing both techniques in infants under two years of age were selected, evaluating variables such as the number of punctures, first-attempt success, healthcare staff perception, associated stress, and the role of simulation in training. Results: Eleven studies were included, comprising clinical trials, observational studies, and training program assessments from different countries. Most reported a higher first-attempt success rate with the ultrasound-guided technique (often exceeding 85%), along with fewer punctures and complications, particularly among less-experienced professionals. Improvements in staff perception were also observed following structured training. The impact on stress experienced by patients and families was less frequently assessed directly, although some studies reported indirect benefits. Conclusions: Ultrasound-guided peripheral vascular cannulation appears to be more effective and safer than the conventional technique in infants, particularly in complex or critical care contexts. Its implementation requires specific training and appropriate resources but could significantly improve clinical outcomes and the pediatric patient experience. Full article
(This article belongs to the Section Pediatrics)
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11 pages, 1617 KiB  
Article
Parental Knowledge and Preventive Strategies in Pediatric IgE-Mediated Food Allergy—Results from a Cross-Sectional Survey
by Francesca Galletta, Angela Klain, Sara Manti, Francesca Mori, Carolina Grella, Leonardo Tomei, Antonio Andrea Senatore, Amelia Licari, Michele Miraglia del Giudice and Cristiana Indolfi
Nutrients 2025, 17(15), 2387; https://doi.org/10.3390/nu17152387 - 22 Jul 2025
Viewed by 283
Abstract
Background/Objectives: Food allergy (FA) is a growing concern in pediatric care, requiring effective avoidance strategies and timely emergency responses. The role of caregivers is central to the daily management of FA. This study aimed to assess parental knowledge, preparedness, and behaviors regarding [...] Read more.
Background/Objectives: Food allergy (FA) is a growing concern in pediatric care, requiring effective avoidance strategies and timely emergency responses. The role of caregivers is central to the daily management of FA. This study aimed to assess parental knowledge, preparedness, and behaviors regarding pediatric FA management, focusing on both prevention and emergency readiness. Methods: A cross-sectional survey was conducted from December 2024 to April 2025 through the SurveyMonkey® platform, promoted by the Italian Society of Pediatric Allergology and Immunology (SIAIP). The anonymous, structured questionnaire was distributed online and in two Italian university hospitals. A total of 129 fully completed responses from caregivers of children with FA were analyzed. The survey explored self-perceived knowledge, symptom recognition, preventive actions, emergency preparedness, and communication practices. Results: Only 9.3% of parents considered themselves “very informed,” while 54.3% reported limited or no knowledge. Just 16.0% recognized all symptoms of an allergic reaction, and only 24.0% could distinguish mild reactions from anaphylaxis. Notably, 67.4% reported not knowing how to respond to anaphylaxis, and 83.7% did not possess an epinephrine auto-injector. Preventive measures at home were inconsistently applied, and 41.1% took no precautions when eating out. Communication with external caregivers was often informal or absent. Only 33% updated physicians regularly. Conclusions: The findings reveal significant gaps in parental preparedness and highlight critical areas for educational intervention. Enhanced caregiver training, standardized communication protocols, and improved clinical follow-up are essential to strengthen pediatric FA management and safety. Full article
(This article belongs to the Special Issue Nutrition and Quality of Life for Patients with Chronic Disease)
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10 pages, 965 KiB  
Review
High-Stakes Hormone: Vasopressin Use as a Last-Line Therapy for Shock in Pediatrics—A Narrative Review
by Marcin Sota, Daria Bramnik, Olivia Gudziewski, Ithamar Cheyne and Małgorzata Mikaszewska-Sokolewicz
Reports 2025, 8(3), 117; https://doi.org/10.3390/reports8030117 - 21 Jul 2025
Viewed by 373
Abstract
Background and Clinical Significance: Shock in pediatric patients remains a leading cause of morbidity and mortality, with refractory cases posing significant challenges. While catecholamines like norepinephrine and epinephrine are standard vasopressors, vasopressin (AVP) has emerged as a potential adjunct therapy. However, its role [...] Read more.
Background and Clinical Significance: Shock in pediatric patients remains a leading cause of morbidity and mortality, with refractory cases posing significant challenges. While catecholamines like norepinephrine and epinephrine are standard vasopressors, vasopressin (AVP) has emerged as a potential adjunct therapy. However, its role in pediatric shock remains controversial due to concerns about efficacy, safety, and appropriate use. This review assesses the current evidence on AVP in pediatric shock. Methods and Results: A comprehensive literature search was conducted using PubMed, Scopus, Web of Science, and Google Scholar, focusing on studies published in the last five years to capture recent advancements. Articles on AVP’s mechanism of action, pharmacokinetics, clinical applications, and safety were included. For background information, studies were not limited by publication date. AVP increases mean arterial pressure (MAP) and systemic vascular resistance (SVR) yet does not significantly reduce mortality. While AVP may be useful in catecholamine-resistant vasoplegia, its advantage over conventional vasopressors remains uncertain. Concerns about ischemic complications, myocardial dysfunction, and thrombocytopenia further limit its routine use. Conclusions: AVP may serve as an adjunct therapy in catecholamine-resistant vasoplegia, but safety concerns and unclear benefits restrict its routine use. Further research is needed to determine the optimal dosing, patient selection, and long-term outcomes. Until then, AVP should remain a last-line therapy when conventional vasopressors fail. Full article
(This article belongs to the Section Critical Care/Emergency Medicine/Pulmonary)
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15 pages, 445 KiB  
Article
Assessing the Alignment Between the Humpty Dumpty Fall Scale and Fall Risk Nursing Diagnosis in Pediatric Patients: A Retrospective ROC Curve Analysis
by Manuele Cesare, Fabio D’Agostino, Deborah Hill-Rodriguez, Danielle Altares Sarik and Antonello Cocchieri
Healthcare 2025, 13(14), 1748; https://doi.org/10.3390/healthcare13141748 - 19 Jul 2025
Viewed by 427
Abstract
Background/Objectives: Falls in hospitalized pediatric patients are frequent and can lead to serious complications and increased healthcare costs. Nurses typically assess fall risk using structured tools such as the Humpty Dumpty Fall Scale (HDFS), alongside nursing diagnoses such as Fall risk ND, [...] Read more.
Background/Objectives: Falls in hospitalized pediatric patients are frequent and can lead to serious complications and increased healthcare costs. Nurses typically assess fall risk using structured tools such as the Humpty Dumpty Fall Scale (HDFS), alongside nursing diagnoses such as Fall risk ND, which are based on clinical reasoning. However, the degree of alignment between the HDFS and the nursing reasoning-based diagnostic approach in assessing fall risk remains unclear. This study aims to assess the alignment between the HDFS and Fall risk ND in identifying fall risk among hospitalized pediatric patients. Methods: A retrospective observational study was conducted in a tertiary pediatric hospital in Italy, including all pediatric patients admitted in 2022. Fall risk was assessed within 24 h from hospital admission using two approaches, the HDFS (risk identified with the standard cutoff, score ≥ 12) and Fall risk ND, based on the nurse’s clinical reasoning and recorded through the PAIped clinical nursing information system. Discriminative performance was analyzed using receiver operating characteristic curve analysis. The area under the curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. A confusion matrix evaluated classification performance at the cutoff (≥12). Results: Among 2086 inpatients, 80.9% had a recorded Fall risk ND. Of the 1853 patients assessed with the HDFS, 52.7% were classified as at risk (HDFS score ≥ 12). The HDFS showed low discriminative ability in detecting patients with a Fall risk ND (AUC = 0.568; 95% CI: 0.535−0.602). The PPV was high (85.1%), meaning that most patients identified as at risk by the HDFS were also judged to be at risk by nurses through Fall risk ND. However, the NPV was low (20.1%), indicating that many patients with low HDFS scores were still diagnosed with Fall risk ND by nurses. Conclusions: The HDFS shows limited ability to discriminate pediatric patients with Fall risk ND, capturing a risk profile that does not fully align with nursing clinical reasoning. This suggests that standardized tools and clinical reasoning address distinct yet complementary dimensions of fall risk assessment. Integrating the HDFS into a structured nursing diagnostic process—guided by clinical expertise and supported by continuous education—can strengthen the effectiveness of fall prevention strategies and enhance patient safety in pediatric settings. Full article
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11 pages, 805 KiB  
Article
Efficacy and Safety of OROSOL Spray for Oral Mucositis in Children: A Randomized, Double-Blind, Placebo-Controlled Trial
by Fatima-Zahra El Barche, Manon D’Almeida, Séverine Dameron and Rémi Shrivastava
Biomedicines 2025, 13(7), 1677; https://doi.org/10.3390/biomedicines13071677 - 9 Jul 2025
Viewed by 357
Abstract
Background: Oral mucositis (OM) is a common and debilitating complication of cancer therapy, particularly in patients undergoing chemotherapy and radiotherapy. It significantly impairs quality of life and may necessitate the interruption of cancer treatment. This study aimed to evaluate the efficacy and [...] Read more.
Background: Oral mucositis (OM) is a common and debilitating complication of cancer therapy, particularly in patients undergoing chemotherapy and radiotherapy. It significantly impairs quality of life and may necessitate the interruption of cancer treatment. This study aimed to evaluate the efficacy and safety of OROSOL, an oral spray device, in managing oral mucositis in pediatric patients undergoing chemotherapy or radiotherapy. Methods: This randomized, double-blind, placebo-controlled clinical trial compared OROSOL to a placebo in children with oral mucositis aged 3 to 17 years. Participants were followed for 28 days with regular medical visits. The primary endpoints were changes in the Oral Assessment Guide (OAG) scores and key symptoms (mucositis score, difficulty in oral feeding, ulceration and erythema, and pain sensation). Safety was assessed via adverse events and local tolerability. Results: Both groups were demographically balanced at baseline (p > 0.6). OROSOL demonstrated significantly greater improvements in the mucositis score beginning on Day 7 (p = 0.0122) and maintained superiority through Day 28 (p = 0.0007). Notable reductions in mucositis severity were observed, with significantly faster relief in the OROSOL group compared to the placebo (p < 0.001 for most timepoints). Oral feeding difficulty also showed a marked decline, with significant improvements starting from Day 5 (p = 0.0153). Ulceration and erythema scores significantly decreased from Day 14 onwards (p = 0.0188). Pain sensation showed a marked reduction from Day 14 (p = 0.0014). No serious adverse events were reported, and tolerability was consistent across all participants. Conclusions: OROSOL has a significant impact on reducing mucositis severity, oral feeding difficulty, ulceration, erythema, and pain. Coupled with its excellent safety profile, it is a valuable therapeutic option. This treatment is particularly beneficial for pediatric patients, ensuring improved comfort and recovery without notable adverse effects. Full article
(This article belongs to the Section Drug Discovery, Development and Delivery)
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15 pages, 1142 KiB  
Article
Prediction of Monoclonal Antibody Pharmacokinetics in Pediatric Populations Using PBPK Modeling and Simulation
by Chiara Zunino, Virginie Gualano, Haiying Zhou, Viera Lukacova and Maxime Le Merdy
Pharmaceutics 2025, 17(7), 884; https://doi.org/10.3390/pharmaceutics17070884 - 5 Jul 2025
Viewed by 571
Abstract
Background: Accurately determining pediatric dosing is essential prior to initiating clinical trials or administering medications in routine clinical settings. In children, ethical considerations demand careful evaluation of both safety and effectiveness. Typically, dosing recommendations for therapeutic proteins, such as monoclonal antibodies (mAbs), [...] Read more.
Background: Accurately determining pediatric dosing is essential prior to initiating clinical trials or administering medications in routine clinical settings. In children, ethical considerations demand careful evaluation of both safety and effectiveness. Typically, dosing recommendations for therapeutic proteins, such as monoclonal antibodies (mAbs), are derived from adult dosages using body weight as a scaling factor. However, this method overlooks key physiological and biochemical distinctions between pediatric and adult patients. Therefore, this could lead to the underexposure of mAbs, limiting their efficacy in this population. Additional methods are necessary to predict pediatric doses mechanistically. For small molecules, physiologically based pharmacokinetic (PBPK) models have been extensively used to predict pediatric doses based on physiological age-related changes and enzymes/transporters ontogeny. This study aims to evaluate the ability of PBPK models to predict mAbs’ pediatric exposure. Methods: Three mAbs were used for model development and validation: bevacizumab, infliximab, and atezolizumab. The PBPK models were built using GastroPlus© Biologics module. For each mAb, the PBPK model was developed based on observed data in healthy and/or patient adults. Then, the physiological parameters were scaled to describe the pediatric physiology to predict exposure to the pediatric populations. Predicted plasma concentration–time courses were overlaid with reported observed data to assess the ability of the PBPK model to predict pediatric exposure. Results: Results showed that PBPK models accurately predicted pediatric pharmacokinetics for mAbs. Conclusions: This research marks a significant step in validating mechanistic extrapolation methods for biologics exposure prediction in children using PBPK models. Full article
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16 pages, 515 KiB  
Article
Fever and Pain in Italian Children: What Pediatricians Really Do
by Giacomo Biasucci, Maria Elena Capra, Antonella Giudice, Delia Monopoli, Roberta Rotondo, Daniela Petracca, Cosimo Neglia, Beatrice Campana and Susanna Esposito
Life 2025, 15(7), 1048; https://doi.org/10.3390/life15071048 - 30 Jun 2025
Viewed by 484
Abstract
Background: Fever and pain are among the most frequent symptoms in pediatric care, requiring timely and appropriate management. While evidence-based guidelines are available, adherence in real-world practice remains variable. This study aimed to explore the attitudes and prescribing behaviors of Italian Primary Care [...] Read more.
Background: Fever and pain are among the most frequent symptoms in pediatric care, requiring timely and appropriate management. While evidence-based guidelines are available, adherence in real-world practice remains variable. This study aimed to explore the attitudes and prescribing behaviors of Italian Primary Care Pediatricians (PCPs) in the management of fever and pain, and to assess their alignment with current clinical recommendations. Materials and Methods: An anonymous, cross-sectional survey consisting of 30 multiple-choice questions was administered to 900 PCPs between 1 July and 30 October 2024. The questionnaire assessed therapeutic preferences, dosing strategies, and perceived knowledge gaps. Invitations were distributed via pediatric scientific societies and regional professional networks. Results: A total of 244 PCPs completed the survey (response rate 27.1%). The majority were aged over 55 years (72.1%), worked in urban settings (71.3%), and had more than 20 years of clinical experience (74.6%). Most respondents (77%) reported managing pediatric fever or pain on a daily basis. Paracetamol was the preferred first-line treatment for fever (95.9%), primarily due to its perceived safety (82.4%). Ibuprofen was favored by 51.6% of those who selected it for its greater effectiveness. The alternating use of paracetamol and ibuprofen for fever was never adopted by 49.6%, while 31.6% employed this strategy, believing it to be more effective. For pain, 67.6% used paracetamol and 26.2% used ibuprofen as first-line treatments; 15.2% reported alternating the two drugs. Correct dosage practices were followed by 63.9% for both medications, although 40.2% did not differentiate dosages between fever and pain management. Conclusions: While general trends showed alignment with current guidelines, notable inconsistencies were observed in drug selection, dosage, and the use of alternating therapies. These findings highlight a pressing need to improve the dissemination and implementation of pediatric fever and pain management guidelines among PCPs in order to reduce unsafe practices, avoid therapeutic errors, and prevent unnecessary strain on emergency care services. Full article
(This article belongs to the Special Issue Pain and Therapy: Historical Perspectives and Future Directions)
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22 pages, 649 KiB  
Systematic Review
Efficacy and Safety of Adenotonsillectomy for Pediatric Obstructive Sleep Apnea Across Various Age Groups: A Systematic Review
by Mohammed Halawani, Arwa Alsharif, Omar Ibrahim Alanazi, Baraa Awad, Abdulaziz Alsharif, Hawazen Alahmadi, Rayan Alqarni, Rahaf Mohammed Alhindi, Abdulmohsen H. Alanazi and Abdulmajeed Hassan Alshamrani
Pediatr. Rep. 2025, 17(4), 71; https://doi.org/10.3390/pediatric17040071 - 25 Jun 2025
Viewed by 1135
Abstract
Objectives: To assess the safety and efficacy of adenotonsillectomy (AT) for treating uncomplicated pediatric obstructive sleep apnea (OSA) in children of different ages. Methods: A systematic search was conducted in four electronic databases, and 71 studies with a total of 9087 [...] Read more.
Objectives: To assess the safety and efficacy of adenotonsillectomy (AT) for treating uncomplicated pediatric obstructive sleep apnea (OSA) in children of different ages. Methods: A systematic search was conducted in four electronic databases, and 71 studies with a total of 9087 participants were included in the analysis. The studies were all before-and-after studies, cohort studies, and randomized controlled trials. Surgical results were analyzed according to age, disease severity, and follow-up duration. Results: Children younger than 7 years at the time of AT had a significantly greater decrease in disease severity, a greater decrease in hypoxemic burden, improved sleep quality, and improved cardiovascular function than children older than 7 years. Both cognitive and behavioral performance improved postoperatively, although these changes were more significantly associated with the duration of follow-up than with age at surgery. Notably, the rate of surgical complications was much greater in children under the age of 3. Conclusions: The current evidence indicates that AT is performed optimally between the ages of 3 and 7 years, offering the greatest chance of disease resolution and remission of associated conditions, balanced with a reduction in surgical risk. We highly recommend conducting high-quality randomized controlled trials to further inform the clinical guidelines for pediatric AT. Full article
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21 pages, 2641 KiB  
Article
Cumulative Transcutaneous Spinal Stimulation with Locomotor Training Safely Improves Trunk Control in Children with Spinal Cord Injury: Pilot Study
by Liubov Amirova, Anastasia Keller, Goutam Singh, Molly King, Parth Parikh, Nicole Stepp, Beatrice Ugiliweneza, Yury Gerasimenko and Andrea L. Behrman
Children 2025, 12(7), 817; https://doi.org/10.3390/children12070817 - 21 Jun 2025
Viewed by 616
Abstract
Background/Objectives: Non-invasive spinal cord transcutaneous stimulation (scTS) has expanded the therapeutic landscape of spinal cord injury (SCI) rehabilitation, offering potential benefits beyond compensatory approaches to paralysis. Children with SCI are particularly susceptible to developing neuromuscular scoliosis due to trunk muscle paralysis and ongoing [...] Read more.
Background/Objectives: Non-invasive spinal cord transcutaneous stimulation (scTS) has expanded the therapeutic landscape of spinal cord injury (SCI) rehabilitation, offering potential benefits beyond compensatory approaches to paralysis. Children with SCI are particularly susceptible to developing neuromuscular scoliosis due to trunk muscle paralysis and ongoing skeletal growth, making targeted interventions crucial. As demonstrated in adults and pediatrics with SCI, the ability of scTS to acutely and safely enable an upright posture and trunk control could be leveraged as a therapeutic adjunct. Activity-based locomotor training (AB-LT) alone significantly improves trunk control in children with SCIs; combining it with scTS may enhance outcomes. This pilot study evaluated the safety, feasibility, and cumulative effects of AB-LT combined with scTS on trunk control in children with SCI. Methods: Three children with SCI completed 19 to 64 sessions of combined AB-LT and scTS. Adverse effects were monitored session to session, and trunk control was assessed pre- and post-intervention. Results: Across 130 interventions in three participants, 88.5% of sessions were free from adverse effects. Reported adverse events included autonomic dysreflexia (5.4%), skin redness at electrode sites (4.6%), and headaches (1.5%). No significant impact of scTS on fatigue or central hemodynamic parameters was observed. Post-intervention, all participants demonstrated improved trunk control during quiet and perturbed sitting. Conclusions: These findings provide the first evidence supporting the safety and feasibility of this combinatorial approach in pediatric SCI rehabilitation while emphasizing the importance of monitoring skin integrity and signs of autonomic dysreflexia. This intervention shows potential synergistic benefits, warranting further research to confirm efficacy and optimize therapeutic protocols. Full article
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18 pages, 1317 KiB  
Article
Stability Assessment of Furosemide Oral Suspension in Hospital Extemporaneous Preparations
by Fai Alkathiri, Omamah Eid, Njoud Altuwaijri, Rihaf Alfaraj, Eram K. Eltahir, Hend Alsabbagh, Shamma Bin Shoia, Mashal Aljead, Haya H. Alnufaie and Ghadah AlToum
Pharmaceuticals 2025, 18(7), 937; https://doi.org/10.3390/ph18070937 - 20 Jun 2025
Viewed by 563
Abstract
Background: Furosemide is a loop diuretic used extensively to treat adult and pediatric patients. In some hospitals, furosemide oral liquids are not available in stock, thus necessitating the extemporaneous preparation of the drug. This study evaluates the stability of on-the-spot formulations of furosemide [...] Read more.
Background: Furosemide is a loop diuretic used extensively to treat adult and pediatric patients. In some hospitals, furosemide oral liquids are not available in stock, thus necessitating the extemporaneous preparation of the drug. This study evaluates the stability of on-the-spot formulations of furosemide oral suspensions from crushed tablets evaluated in various vehicles: Dextrose 50%, Dextrose 70%, Ora-Sweet, and Ora-Plus over 60 days. This examination was prompted by the frequent shortage of certain excipients in the hospital, leading to the need to switch to Dextrose 50% or Dextrose 70% when Ora-Sweet and Ora-Plus are out of stock. Methods: The extemporaneous furosemide oral suspensions were prepared following the same compounding method used in the pharmacy. The suspensions were maintained at 4 °C in the refrigerator and assessed immediately and later, on days 7, 14, 30, and 60. The assessed parameters included visual appearance, redispersion time, sedimentation volume, and pH levels for stability analysis. We also examined the drug content, dissolution of the suspension, and microbiological stability. Results: Initial examinations indicated that Dextrose 50% and Ora-Plus maintained pH levels and stable appearances, while significant changes, mainly in appearance and redispersion time, indicated the instability of Dextrose 70%. Ora-Sweet showed fluctuations but stabilized by day 30. Dissolution studies demonstrated that Ora-Plus had dissolution characteristics superior to the other formulations, while Dextrose 50% showed declining dissolution percentages over time. Overall, the Ora-Plus vehicle showed superior stability (60 days), followed by Ora-Sweet (30 days), while Dextrose 70% and Dextrose 50% showed shorter stability durations of 14 and 7 days, respectively. The microbiological test results showed no microbial growth. Conclusions: This study demonstrates that the vehicle used in extemporaneous furosemide suspensions critically affects their stability and performance. Ora-Plus emerged as the most suitable vehicle, maintaining physical, chemical, and microbiological stability over 60 days, with consistent pH, redispersion, and dissolution behavior. Ora-Sweet showed intermediate stability (30 days), while Dextrose 50% and 70% exhibited early instability—7 and 14 days, respectively—marked by sedimentation, poor redispersibility, and declining drug release. These findings underscore the importance of vehicle selection and regular stability monitoring in compounded formulations to ensure therapeutic reliability and patient safety. Full article
(This article belongs to the Section Pharmaceutical Technology)
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16 pages, 815 KiB  
Review
Nerve Growth Factor in Pediatric Brain Injury: From Bench to Bedside
by Lorenzo Di Sarno, Serena Ferretti, Lavinia Capossela, Antonio Gatto, Valeria Pansini, Anya Caroselli, Luigi Manni, Marzia Soligo and Antonio Chiaretti
Pharmaceuticals 2025, 18(6), 929; https://doi.org/10.3390/ph18060929 - 19 Jun 2025
Viewed by 444
Abstract
Background: Traumatic brain injury (TBI) and hypoxic–ischemic encephalopathy (HIE) are major causes of long-term neurological disability in children, with limited options for effective neuronal recovery. Recent research has highlighted the therapeutic potential of nerve growth factor (NGF) in promoting neural repair through mechanisms [...] Read more.
Background: Traumatic brain injury (TBI) and hypoxic–ischemic encephalopathy (HIE) are major causes of long-term neurological disability in children, with limited options for effective neuronal recovery. Recent research has highlighted the therapeutic potential of nerve growth factor (NGF) in promoting neural repair through mechanisms such as neuroprotection, neurogenesis, and the modulation of neuroinflammation. This review evaluates the current evidence on NGF as a treatment strategy for pediatric brain injury, emphasizing its mechanisms of action and translational clinical applications. Methods: A comprehensive review was conducted using the PubMed, Scopus, and Cochrane CENTRAL databases to identify studies published between 1 January 1978 and 1 March 2025, investigating NGF in the context of brain injury. The inclusion criteria comprised studies assessing neurological outcomes through clinical scales, biochemical markers, neuroimaging, or electrophysiological examinations. Results: Seventeen studies met the inclusion criteria, encompassing both preclinical and clinical research. Preclinical models consistently demonstrated that NGF administration reduces neuroinflammation, enhances neurogenesis, and supports neuronal survival following TBI and HIE. Clinical studies, including case reports of pediatric patients treated with intranasal NGF, reported improvements in motor and cognitive function, neuroimaging findings, and electrophysiological parameters, with no significant adverse effects observed. Conclusions: NGF demonstrates significant promise as a neuroprotective and neuroregenerative agent in pediatric brain injury, with both experimental and early clinical evidence supporting its safety and efficacy. Large-scale controlled clinical trials are warranted to validate these preliminary findings and to determine the optimal dosage regimens and administration schedules for NGF in the treatment of TBI and HIE. Full article
(This article belongs to the Special Issue Applications of Nerve Growth Factor in Pharmaceuticals)
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Review
Recovery Time, Patient Satisfaction, and Safety of Intranasal Sedatives in Pediatric Dentistry: A Systematic Review and Meta-Analysis
by Selvakumar Haridoss, Sushmita Shan, Guna Shekhar Madiraju, Kavitha Swaminathan, Rohini Mohan, Faris Yahya I. Asiri, Yousef Majed Almugla and Mohammad Alhussein Hamidaddin
J. Clin. Med. 2025, 14(12), 4038; https://doi.org/10.3390/jcm14124038 - 7 Jun 2025
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Abstract
Background: Intranasal sedation is commonly used in pediatric dentistry to manage dental anxiety and improve patient compliance. This systematic review and meta-analysis aimed to evaluate the recovery time, patient satisfaction, and adverse effects of the intranasal sedatives midazolam, dexmedetomidine, and ketamine in pediatric [...] Read more.
Background: Intranasal sedation is commonly used in pediatric dentistry to manage dental anxiety and improve patient compliance. This systematic review and meta-analysis aimed to evaluate the recovery time, patient satisfaction, and adverse effects of the intranasal sedatives midazolam, dexmedetomidine, and ketamine in pediatric dental procedures. Methods: A systematic search of PubMed, Scopus, the Web of Science, the Cochrane Library, Embase, and Google Scholar was conducted following the PRISMA 2020 guidelines. Only randomized controlled trials (RCTs) involving intranasal sedation in pediatric patients (≤18 years) were included. The revised Cochrane risk of bias tool (RoB 2) was employed to assess study quality. A meta-analysis using a random-effects model was performed to evaluate the recovery time. Results: Twenty-one RCTs were included in this review. A meta-analysis of seven studies revealed that dexmedetomidine was associated with significantly longer recovery times compared to midazolam and ketamine. Specifically, midazolam demonstrated the shortest recovery time (mean difference: −19.1 min, p < 0.05), followed by ketamine (mean difference: −15.6 min, p < 0.05). A qualitative analysis of adverse effects showed mild to moderate complications, including nasal irritation (midazolam), prolonged sedation (dexmedetomidine), and hypersalivation (ketamine). Patient satisfaction was found to be highest with dexmedetomidine, although midazolam was preferred for its faster onset of sedation. Conclusions: Intranasal sedation in pediatric dentistry is a safe and effective approach, with each agent exhibiting distinct recovery profiles and safety considerations. The findings emphasize the importance of standardized sedation protocols and the need for further research into the long-term outcomes of these sedatives in pediatric populations. Full article
(This article belongs to the Special Issue Paediatric Anaesthesia: Clinical Updates and Perspectives)
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