Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants.

Introduction: Rotavirus-associated diarrheal diseases significantly burden healthcare systems, particularly affecting infants under five years. Both Rotarix™ (RV1) and RotaTeq™ (RV5) vaccines have been effective but have distinct application schedules and limited interchangeability data. This study aims to provide evidence on the immunogenicity, reactogenicity, and safety of mixed RV1-RV5 schedules compared to their standard counterparts. Methods: This randomized, double-blind study evaluated the non-inferiority in terms of immunogenicity of mixed rotavirus vaccine schedules compared to standard RV1 and RV5 schedules in a cohort of 1,498 healthy infants aged 6 to 10 weeks. Participants were randomly assigned to one of seven groups receiving various combinations of RV1, and RV5. Standard RV1 and RV5 schedules served as controls of immunogenicity, reactogenicity, and safety analysis. IgA antibody levels were measured from blood samples collected before the first dose and one month after the third dose. Non-inferiority was concluded if the reduction in seroresponse rate in the mixed schemes, compared to the standard highest responding scheme, did not exceed the non-inferiority margin of -0.10. Reactogenicity traits and adverse events were monitored for 30 days after each vaccination and analyzed on the entire cohort. Results: Out of the initial cohort, 1,365 infants completed the study. Immunogenicity analysis included 1,014 infants, considering IgA antibody titers ≥20 U/mL as seropositive. Mixed vaccine schedules demonstrated non-inferiority to standard schedules, with no significant differences in immunogenic response. Safety profiles were comparable across all groups, with no increased incidence of serious adverse events or intussusception. Conclusion: The study confirms that mixed rotavirus vaccine schedules are non-inferior to standard RV1 and RV5 regimens in terms of immunogenicity and safety. This finding supports the flexibility of rotavirus vaccination strategies, particularly in contexts of vaccine shortage or logistic constraints. These results contribute to the global effort to optimize rotavirus vaccination programs for broader and more effective pediatric coverage.Clinical trial registration: ClinicalTrials.gov, NCT02193061.

Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Study Protocol.

BACKGROUND AND OBJECTIVES: Traumatic brain injury (TBI) is a major global public health problem. It is a leading cause of death and disability in children and adolescents worldwide. Although increased intracranial pressure (ICP) is common and associated with death and poor outcome after pediatric TBI, the efficacy of current ICP-based management remains controversial. We intend to provide Class I evidence testing the efficacy of a protocol based on current ICP monitor-based management vs care based on imaging and clinical examination without ICP monitoring in pediatric severe TBI. METHODS: A phase III, multicenter, parallel-group, randomized superiority trial performed in intensive care units in Central and South America to determine the impact on 6-month outcome of children aged 1-12 years with severe TBI (age-appropriate Glasgow Coma Scale score ≤8) randomized to ICP-based or non-ICP-based management. EXPECTED OUTCOMES: Primary outcome is 6-month Pediatric Quality of Life. Secondary outcomes are 3-month Pediatric Quality of Life, mortality, 3-month and 6-month Pediatric extended Glasgow Outcome Score, intensive care unit length of stay, and number of interventions focused on treating measured or suspected intracranial hypertension. DISCUSSION: This is not a study of the value of knowing the ICP in sTBI. This research question is protocol-based. We are investigating the added value of protocolized ICP management to treatment based on imaging and clinical examination in the global population of severe pediatric TBI. Demonstrating efficacy should standardize ICP monitoring in severe pediatric TBI. Alternate results should prompt reassessment of how and in which patients ICP data should be applied in neurotrauma care.

Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Research Algorithms.

BACKGROUND AND OBJECTIVES: The efficacy of our current approach to incorporating intracranial pressure (ICP) data into pediatric severe traumatic brain injury (sTBI) management is incompletely understood, lacking data from multicenter, prospective, randomized studies. The National Institutes of Health-supported Benchmark Evidence from Latin America-Treatment of Raised Intracranial Pressure-Pediatrics trial will compare outcomes from pediatric sTBI of a management protocol based on ICP monitoring vs 1 based on imaging and clinical examination without monitoring. Because no applicable comprehensive management algorithms for either cohort are available, it was necessary to develop them. METHODS: A consensus conference involving the 21 intensivists and neurosurgeons from the 8 trial sites used Delphi-based methodology to formulate management algorithms for both study cohorts. We included recommendations from the latest Brain Trauma Foundation pediatric sTBI guidelines and the consensus-based adult algorithms (Seattle International Brain Injury Consensus Conference/Consensus Revised Imaging and Clinical Examination) wherever relevant. We used a consensus threshold of 80%. RESULTS: We developed comprehensive management algorithms for monitored and nonmonitored cohort children with sTBI. We defined suspected intracranial hypertension for the nonmonitored group, set minimum number and timing of computed tomography scans, specified minimal age-adjusted mean arterial pressure and cerebral perfusion pressure targets, defined clinical neuroworsening, described minimal requisites for intensive care unit management, produced tiered management algorithms for both groups, and listed treatments not routinely used. CONCLUSION: We will study these protocols in the Benchmark Evidence from Latin America-Treatment of Raised Intracranial Pressure-Pediatrics trial in low- and middle-income countries. Second, we present them here for consideration as prototype pediatric sTBI management algorithms in the absence of published alternatives, acknowledging their limited evidentiary status. Therefore, herein, we describe our study design only, not recommended treatment protocols.

Study of Ethylene-Removing Materials Based on Eco-Friendly Composites with Nano-TiO2.

Ethylene is a phytohormone that is responsible of fruit and vegetable ripening. TiO2 has been studied as a possible solution to slowing down unwanted ripening processes, due to its photocatalytic capacity which enables it to remove ethylene. Thus, the objective of this study was to develop nanocomposites based on two types of eco-friendly materials: Mater-Bi® (MB) and poly(lactic acid) (PLA) combined with nano-TiO2 for ethylene removal and to determine their ethylene-removal capacity. First, a physical-chemical characterization of nano-TiO2 of different particle sizes (15, 21, 40 and 100 nm) was done through structural and morphological analysis (DRX, FTIR and TEM). Then, its photocatalytic activity and the ethylene-removal capacity were determined, evaluating the effects of time and the type of light irradiation. With respect to the analysis of TiO2 nanoparticles, the whole samples had an anatase structure. According to the photocatalytic activity, nanoparticles of 21 nm showed the highest activity against ethylene (~73%). The results also showed significant differences in ethylene-removal activity when comparing particle size and type and radiation time. Thus, 21 nm nano-TiO2 was used to produce nanocomposites through the melt-extrusion process to simulate industrial processing conditions. With respect to the nanocomposites' ethylene-removing properties, there were significant differences between TiO2 concentrations, with samples with 5% of active showed the highest activity (~57%). The results obtained are promising and new studies are needed to focus on changes in material format and the evaluation in ethylene-sensitive fruits.

Clinical and Epidemiological Characteristics of Paediatric Patients Diagnosed with COVID-19 in a Tertiary Hospital in Mexico City.

COVID-19 affects the paediatric population less frequently than adults. A retrospective study was performed in a tertiary paediatric hospital in Mexico City in children <18 years of age who were hospitalized with a positive reverse transcription-polymerase chain reaction for SARS-CoV-2. Included in the study were 86 patients with a median age of 10 years old (IQR 2.6-14.3 years), who were classified in three groups: previously healthy, with chronic disease and immunosuppressed patients. The principal signs and symptoms were fever (81%), cough (51%) and headache (35%). A total of 20 patients (23%) required management in the paediatric intensive care unit (PICU) and 17% needed mechanical ventilation for an average of 12.7 days (IQR 2-29 days). There was no statistically significant difference between the three clinical classification groups in those patients admitted to the PICU, most of which were previously healthy patients. The mortality rate was 5% (four patients). Given that the paediatric population is susceptible to infection, potential transmitters and to clinical presentations with variable degrees of severity, it is important to continue reinforcing social distancing measures.

Co-infection with Streptococcus anginosus and Mycobacterium tuberculosis in an immunocompetent pediatric patient. A case report.

BACKGROUND: Simultaneous infection in tuberculosis (TB) is rare. The mixed infection between Streptococcus anginosus group (SAG) and M. tuberculosis (MTB) has not been reported in children. The aim of this report was to describe a pediatric case with a pulmonary abscess caused by the duality SAG-MTB co-infection. CASE PRESENTATION: An 11-year-old boy with an acute onset of throbbing pain of two-day evolution located in the anterior chest wall. The patient reported a history of fever, cough and rhinorrhea during the last seven days. An anterior chest radiography revealed a heterogenic opacity at the lower right lobe while the lateral projection showed an obliteration at the anterior diaphragmatic insertion. Parenteral Ceftriaxone (100 mg/kg/day) and Dicloxacillin (200 mg/kg/day) was started. The abscess was subsequently drained and analyzed. After a year of follow-up, the patient remained asymptomatic. CONCLUSION: This case represents the first reported case of pulmonary co-infection involving MTB and SAG in an immunocompetent pediatric patient.

Influence of pre-pregnancy body mass index (p-BMI) and gestational weight gain (GWG) on DNA methylation and protein expression of obesogenic genes in umbilical vein.

Understanding the regulatory mechanisms that affect obesogenic genes expression in newborns is essential for early prevention efforts, but they remain unclear. Our study aimed to explore whether the maternal p-BMI and GWG were associated with regulatory single-locus DNA methylation in selected obesogenic genes. For this purpose, DNA methylation was assayed by Methylation-Sensitive High Resolution Melting (MS-HRM) technique and Sanger allele-bisulfite sequencing in fifty samples of umbilical vein to evaluate glucosamine-6-phosphate deaminase 2 (GNPDA2), peroxisome proliferator-activated receptor gamma coactivator 1 alpha (PGC1α), and leptin receptor (LEPR) genes. Correlations between DNA methylation levels and indicators of maternal nutritional status were carried out. Western blotting was used to evaluate protein expression in extracts of the same samples. Results indicated that GNPDA2 and PGC1α genes have the same level of DNA methylation in all samples; however, a differential DNA methylation of LEPR gene promoter was found, correlating it with GWG and this correlation is unaffected by maternal age or unhealthy habits. Furthermore, leptin receptor (Lep-Rb) was upregulated in samples that showed the lowest levels of DNA methylation. This study highlights the association between poor GWG and adjustments on obesogenic genes expression in newborn tissues with potential consequences for development of obesity in the future.

Metabolic Syndrome and Cardiovascular Risk in People Treated with Long-Acting Injectable Antipsychotics.

BACKGROUND: People with schizophrenia and other severe mental disorders have an increased mortality mainly attributed to natural causes, specifically cardiovascular disease and cancer. The metabolic syndrome and the Framingham Risk Score are epidemiologic tools related to long-term cardiovascular disease risk and they are increased in people with severe mental disorders. This increase has been attributed both to the disorder itself and to the use of antipsychotic drugs. OBJECTIVE: To quantify the cardiovascular risk in a group of people treated with long-acting injectable antipsychotics. METHODS: This is a cross-sectional study developed in an outpatient mental health clinic in which the prevalence of metabolic syndrome was estimated and the cardiovascular risk was measured using the Framingham Risk Score. All the analyses were separated by gender. RESULTS: 130 people (81 men) were recruited. According to the International Diabetes Federation criteria, 60 participants (46,2%) had metabolic syndrome. The individual criterion most often met in both genders was obesity. The mean Framingham Risk Score for the sample was moderate, 7,7 (SD: 6,3). For women, the risk was lower (mean 5,7, SD: 4,9) than for men (mean=9, SD: 6,7). There were no significant differences in the prevalence of metabolic syndrome and Framingham Risk Scores by longacting injectable antipsychotic or years of treatment. CONCLUSION: The prevalence of metabolic syndrome and the cardiovascular risk are high in people with psychosis treated with long acting injectable antipsychotics. To better address this vulnerability, the recommendations involve both behavioral and pharmacological interventions.

Característica clínico-epidemiológica de los pacientes pediátricos con cetoacidosis diabética / Clinical and epidemiological characteristics of pediatric patients with diabetic ketoacidosis

Antecedentes: La Cetoacidosis diabética (CAD) es una complicación de la Diabetes Mellitus, cuya importancia va cada vez en aumento. Es el trastorno metabólico que causa más ingresos a las unidades de cuidado inten- sivo pediátrico con una tasa de hospitalización que se ha mantenido alrededor de 10 por 100.000 niños/año. Objetivo: Describir las características clínico-epidemiológicas de la cetoacidosis diabética en los pacientes meno- res de 18 años. Pacientes y métodos: Se reali- zó un estudio descriptivo. La información fue recopilada mediante encuesta sobre caracte- rísticas socio-demográficas, epidemiológicas y diagnóstica en niños con CAD que fueron ingresados en la emergencia de pediatría del Hospital Nacional Dr. Mario Catarino Rivas (HNMCR), durante el período de agosto 2013 a agosto del 2015 (n=30). Resultados: Se en- contró 18 (60%) mujeres y 12 (40%) varones con CAD. El promedio de edad de los pacientes diagnosticados con CAD fue de 12 años, con una mediana de 13 años. El 50% de los pacien- tes con CAD eran debutantes y el 20% tenían 2 años de diagnóstico. Las infecciones de tracto urinario estuvieron presentes en el 40% de los casos. El promedio de glicemia sérica en los pacientes con CAD fue de 500 mg/dl. El edema cerebral fue la principal complicación encontrada en un 33.3% de los casos. Fallecie- ron el 7% de los pacientes con CAD. Conclusio- nes: La CAD es frecuente en mujeres adoles- centes y es desencadenado principalmente por infecciones del tracto urinario...(AU)

Anestesia intravenosa total en cirugía de tumor carotídeo / Total intravenous anesthesia in carotid surgery tumor

Mujer de 18 años operada en junio del 2011 por el Servicio de Cabeza y Cuello del Hospital Nacional Arzobispo Loayza, por una tumoración cervical izquierda. La tomografía en fase angiográfica mostró un tumor estadio Shamblin III en bifurcación carotidea. Programada para exeresis de glomus carotídeo y ante los antecedentes de secuelas neurológicas postquirúrgicas de este estadio, se elige la técnica de anestesia intravenosa total con propofol, modo infusión controlada por objetivo, por sus propiedades de protección cerebral, e infusión de remifentanilo. Se monitorizó profundidad anestésica continua con índice biespectral. En el transoperatoio se lacera carótida común, se clampa la arteria durante 5 horas con liberación intermitente al cabo distal para evidenciar circulación cerebral colateral. Se coloca bypass con injerto de safena externa y se realiza exeresis final de tumor. Paciente hemodinámicamente estable, pasa a la unidad de recuperación con Ramsay y luego de 11 horas de anestesia.

Female, 18 years old, operated in June 2011 by Servicio de Cabeza y Cuello del Hospital Nacional Arzobispo Loayza, because of a left cervical tumor. The angiography phase of the CT scan showed a carotid bifurcation tumor Shamblin III stage. Scheduled for exeresis of carotid glomus and aware of the fact of postoperative neurological sequelae of this stage tumor, we choose the total intravenous anesthesia technique with propofol in target controlled infusion, because of its brain protective properties, and infusion of remifentanil. Depth of anesthesia was monitors continuously with bispectral index. Common carotid artery was lacerated during surgery, and it was clamped for 5 hours with intermittent release of the distal stump to asses collateral cerebral circulation. A bypass with saphenous graft was placed and the tumor exeresis was performed. A stabled patient went to the recovery unit with Ramsay 52 after 11 hours of anesthesia.

Expression of P-glycoprotein and metallothionein in gastrointestinal stromal tumor and leiomyosarcomas. Clinical implications.

We investigated the expression of P-glycoprotein (P-GP) and metallothionein (MT) in a series of 92 GIST and 14 gastrointestinal leiomyosarcomas (GILMS) with the purpose to expand our knowledge on the biological bases of GIST chemo-resistance and to ascertain their significance in patients' prognosis. P-GP expression was more frequent in GIST than in GI-LMS (83.7% vs. 21.4%, p<0.001), with no difference between low- and high-risk GIST (p=1.000) or low- and high-grade GI-LMS (p=0.538). P-GP expression was unrelated to anatomic location (gastric vs. intestinal) in GIST (39/45 vs. 35/43, p=0.770) and in GI-LMS (0/2 vs. 2/6, p=1.000). MT expression was non-significantly higher in GI-LMS than in GIST (35.7% vs. 14.1%, p=0.060), with no difference between low- and high-risk GIST (p=1.000) or low- and high-grade GI-LMS (p=1.000). MT expression was unrelated to the anatomic location (gastric vs. intestinal) in GIST (7/45 vs. 6/43) and GI-LMS (0/2 vs. 1/6) (p=1.000 and p=0.1000, respectively). Overall tumor-specific survival (p< 0.001) and disease-free survival (p<0.001) were different in GIST as compared with GI-LMS, and the number of events was higher in GI-LMS. When the survival analysis took into consideration P-GP or MT expression, the overall survival in GIST was influenced by the expression of MT (p=0.021) but not by that of P-GP (p=0.638). However, in GI-LMS, P-GP expression influenced disease-free survival (p=0.050); in addition, it is important to recognize the limited value of these results because of the low number of cases involved in the study. Differential expression of P-GP and MT might explain the known variability in response to systemic chemotherapy in these tumors. Detection of P-GP and MT seems to add certain prognostic value in GIST (MT) or GI-LMS (P-GP).

Miopatía por cloroquina / Chloroquine myopathy

La cloroquina es un antipalúdico de síntesis, también empleado en el tratamiento de diversas enfermedades reumatológicas y dermatológicas. Entre sus efectos secundarios, asociados a uso prolongado, destacan retinopatía, miopatía y cardiomiopatía. Describimos el caso de una mujer de 60 años diagnosticada de artritis reumatoide hace 8 años y tratada desde entonces con cloroquina, que presentó signos de insuficiencia cardiaca congestiva y una tetraparesia de predominio proximal. Se practicó biopsia de músculo esquelético que puso de manifiesto la existencia de una miopatía necrosante-vacuolar, observándose en el estudio ultraestructural fibras musculares muy alteradas con presencia de perfiles curvilíneos como los que se describen en la miopatía causada por cloroquina (AU)

Es necesario producir menos residuos

Reportaje a Paulo Cesar Pinto, Consultor en Salud Ambiental de la OPS en el que recuerda que la más importante recomendación de la Agenda 21 es minimizar la producción de residuos sólidos urbanos y que es sobre todo una cuestión educacional y cultural de las personas

Es necesario producir menos residuos

Reportaje a Paulo Cesar Pinto, Consultor en Salud Ambiental de la OPS en el que recuerda que la más importante recomendación de la Agenda 21 es minimizar la producción de residuos sólidos urbanos y que es sobre todo una cuestión educacional y cultural de las personas