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International adoption has declined in recent years, although international adoption of children with special needs arises. We aim to describe our experience in international adoption of children with special needs and to analyze the concordance between the pathologies included in pre-adoption reports and the diagnosis made upon arrival. We conducted a retrospective descriptive study including internationally adopted children with special needs evaluated at the reference unit of La Paz University Hospital (Madrid) between 2016-2019. Epidemiological and clinical variables were collected from medical records, and pre-adoption reports were compared to established diagnoses following their evaluation and complementary tests. Fifty-seven children were included: 36.8% females, median of age: 27 months [IQR: 17-39], mostly coming from China (63.2%) and Vietnam (31.6%). The main pathologies described in the pre-adoption reports were hematological (22.6%) and neurological (24.6%). The initial diagnosis that motivated the international adoption via special needs was confirmed in 79.0% of the children. After evaluation, 17.5% were diagnosed with weight and growth delay and 27.4% with microcephaly, not previously reported. Infectious diseases were also prevalent (29.8%). Only 7% provided a complete immunization schedule. Conclusion: According to this series, the pre-adoption reports appear accurate, with a very low rate of new diagnosis. Pre-existing conditions were confirmed in over 75% of cases. Complete evaluation upon arrival, including infectious diseases screening and close follow-up, ideally by experienced multidisciplinary teams in specialized units, is recommended to provide comprehensive care.

Objectives. Congenital cytomegalovirus infection (cCMV) has been considered more prevalent among HIV-exposed children during pregnancy. Spanish national guidelines recommend the cCMV screening in these newborns. Nowadays, pregnant women have a better control of HIV infection compared to previous decades. We aim to analyze the prevalence and associated risk factors to cCMV in these children. Patients and methods. A retrospective cross-sectorial study was performed. All newborns exposed to HIV were assisted in a third-level hospital (2014-2020). Epidemiological and clinical data of the mother and newborn were recorded. Shell vial urine culture and/or CRP were performed along the two first weeks of life for the neonatal screening of cCMV. Results. Overall 69 newborns were enrolled. A high proportion (82.4%) of the mothers had been diagnosed with HIV before getting pregnant. All women received ART during the pregnancy. Median T-CD4 lymphocytes before delivery was 641/mm3 (IQR: 480-865) and the viral load was undetectable in 83.6%. Serological test for CMV along the first trimester of pregnancy was performed in 73.5% (positive IgG in 96%). There were no congenital cases of HIV neither cCMV (CI 95%:0-5.3%). Conclusions. The cCMV prevalence in newborns exposed to HIV was 0%, lower than reported before, probably related to a better and earlier ART during pregnancy, leading to a better immunological status.

Objetivo Analizar la valoración de la atención a los niños con patología crónica compleja (NPCC) en atención primaria (AP), desde el punto de vista de sus médicos y de sus familias. Diseño Estudio observacional, descriptivo y transversal. Emplazamiento Pediatría de AP y unidad de patología crónica compleja (UPCC) del Hospital Universitario La Paz (HULP). Participantes Pacientes y familiares de la UPCC y sus médicos de AP de la Comunidad de Madrid (CAM). Intervenciones Realización de encuestas validadas presenciales y online. Mediciones principales Grado de satisfacción en la formación, capacitación y manejo específico del NPCC según escalas tipo Likert. Resultados Se encuestaron 53 familias y 170 médicos de AP (96,5% pediatras). Los resultados de la encuesta a familiares revelan descoordinación entre niveles asistenciales (73,6%), escasa confianza en el primer nivel asistencial e impresión de poca capacidad de resolución de problemas por parte de pediatría de AP (50%). Entre los médicos de AP destaca la poca formación para el seguimiento de los NPCC (96,5%), escasa experiencia en su manejo (93%) e insuficiente comunicación con el hospital (80,5%). La falta de tiempo en las consultas es un problema común, percibido por pediatras y pacientes. Conclusiones La falta de coordinación entre AP y atención hospitalaria (AH) se detecta como un problema importante en la continuidad asistencial de NPCC. Son necesarias intervenciones que mejoren esta coordinación. La AP es cercana a la familia, pero precisa mejorar la formación y capacitación de los profesionales en problemas de salud y soporte tecnificado de NPCC, así como incrementar el tiempo necesario para su atención.

Objective To evaluate the efficacy of sample pooling compared to the individual analysis for the diagnosis of coronavirus disease 2019 (COVID-19) by using different commercial platforms for nucleic acid extraction and amplification. Methods A total of 3519 nasopharyngeal samples received at nine Spanish clinical microbiology laboratories were processed individually and in pools (342 pools of ten samples and 11 pools of nine samples) according to the existing methodology in place at each centre. Results We found that 253 pools (2519 samples) were negative and 99 pools (990 samples) were positive; with 241 positive samples (6.85%), our pooling strategy would have saved 2167 PCR tests. For 29 pools (made out of 290 samples), we found discordant results when compared to their correspondent individual samples, as follows: in 22 of 29 pools (28 samples), minor discordances were found; for seven pools (7 samples), we found major discordances. Sensitivity, specificity and positive and negative predictive values for pooling were 97.10% (95% confidence interval (CI), 94.11–98.82), 100%, 100% and 99.79% (95% CI, 99.56–99.90) respectively; accuracy was 99.80% (95% CI, 99.59–99.92), and the kappa concordant coefficient was 0.984. The dilution of samples in our pooling strategy resulted in a median loss of 2.87 (95% CI, 2.46–3.28) cycle threshold (Ct) for E gene, 3.36 (95% CI, 2.89–3.85) Ct for the RdRP gene and 2.99 (95% CI, 2.56–3.43) Ct for the N gene. Conclusions We found a high efficiency of pooling strategies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA testing across different RNA extraction and amplification platforms, with excellent performance in terms of sensitivity, specificity and positive and negative predictive values.

BackgroundCarbapenem-resistant Enterobacteriaceae (CRE) are an emerging problem in the paediatric population worldwide with high mortality rates in bloodstream infection (BSI).ObjectivesTo evaluate predictors of 30 day mortality in CRE BSI in a paediatric cohort.MethodsA retrospective observational single-centre study (December 2005–August 2018) was conducted. Cases of CRE BSI in children 0 to 16 years were included. Microbiological identification (MALDI Biotyper) and antimicrobial susceptibility testing (Vitek2® and MicroScan panel NBC44) according to EUCAST breakpoints were performed. PCR OXVIKP® was used to confirm carbapenemase genes (OXA-48, VIM, KPC, NDM). Demographic characteristics, underlying diseases, source of bacteraemia, antimicrobial therapy and outcomes were collected from medical records. Survival analysis to establish predictors of 30 day mortality was performed.ResultsThirty-eight cases were included; 76.3% were hospital-acquired infections and 23.7% related to healthcare. All patients had at least one underlying comorbidity and 52.6% were recipients of an organ transplant. VIM carbapenemase was the predominant mechanism (92.1%). Previous CRE colonization or infection rate was 52.6%. Intestinal tract (26.3%) and vascular catheter (21.1%) were the most common sources of infection. Crude mortality within 30 days was 18.4% (7/38); directly related 30 day mortality was 10.5%. Conditions associated with an increment in 30 day mortality were intensive care admission and inadequate empirical therapy (P ConclusionsCRE BSI mortality rate is high. The most important factor related to 30 day survival in our CRE BSI cohort in children was empirical treatment that included at least one active antibiotic.

Background: Zika virus (ZIKV) infection has been associated with congenital microcephaly and other neurodevelopmental abnormalities. There is little published research on the effect of maternal ZIKV infection in a non-endemic European region. We aimed to describe the outcomes of pregnant travelers diagnosed as ZIKV-infected in Spain, and their exposed children. Methods: This prospective observational cohort study of nine referral hospitals enrolled pregnant women (PW) who travelled to endemic areas during their pregnancy or the two previous months, or those whose sexual partners visited endemic areas in the previous 6 months. Infants of ZIKV-infected mothers were followed for about two years. Results: ZIKV infection was diagnosed in 163 PW, 112 (70%) were asymptomatic and 24 (14.7%) were confirmed cases. Among 143 infants, 14 (9.8%) had adverse outcomes during follow-up, three had a congenital Zika syndrome (CZS), and 11 other potential Zika-related outcomes. The overall incidence of CZS was 2.1% (95%CI: 0.4&ndash, 6.0%), but among infants born to ZIKV-confirmed mothers, this increased to 15.8% (95%CI: 3.4&ndash, 39.6%). Conclusions: A nearly 10% overall risk of neurologic and hearing adverse outcomes was found in ZIKV-exposed children born to a ZIKV-infected traveler PW. Longer-term follow-up of these children is needed to assess whether there are any later-onset manifestations.

Introduction: Human parechovirus (HPeV) is one of the recently described picornaviridae viruses that have been associated with fever without source (FWS), clinical sepsis, gastroenteritis, meningitis, or encephalitis in very young infants. The aim of this study is to describe the epidemiology and clinical features of these viruses. Patients and methods: A prospective multicentre 3-year study was conducted in 12 hospitals in Spain. Out of 850 specimens examined, 47 were positive (5.52%), with HPeV-3 being the most frequent (29 cases). Infections occurred throughout the year, but mainly in May and July, and a biennial distribution was observed. More than half (57%) were neonates, and only 2 children were older than 3 months. Fever was present in all children, with irritability in 45%, rash in 18.6%, and diarrhoea in 14%. The results of biochemical tests were all in normal range. The most common final diagnosis was FWS (61%), followed by clinical sepsis (29%). Up to 29% of infants were admitted to the intensive care unit, but only one patient had sequelae. Results: Out of 850 specimens examined, 47 were positive (5.52%) for HPeV, with HPeV-3 being the most frequent (29 cases). Infections occurred throughout the year, but mainly in May and July, and a biennial distribution was observed. More than half (57%) were neonates, and only 2 children were older than 3 months. Fever was present in all children, with irritability in 45%, rash in 18.6%, and diarrhoea in 14%. The results of biochemical tests were all in normal range. The most common final diagnosis was FWS (61%), followed by clinical sepsis (29%). Up to 29% of infants were admitted to the intensive care unit, but only one patient had sequelae. Conclusions: HPeV circulates in our country, mainly during spring and summer, and affects young infants with a FWS and clinical sepsis. Molecular diagnostic techniques in all hospitals could help in improving the management of patients with these infections. Resumen: Introducción: Los parechovirus humanos (HPeV) son virus de la familia Picornaviridae, recientemente descritos, a los que se atribuyen cuadros de fiebre sin foco (FSF), sepsis clínica, gastroenteritis, meningitis o encefalitis fundamentalmente en lactantes pequeños. Nuestro objetivo fue describir la epidemiología y las características clínicas de las infecciones por HPeV en nuestro medio. Pacientes y métodos: Estudio multicéntrico prospectivo, llevado a cabo en 12 hospitales a nivel nacional, entre 2013-2015, en niños 3 meses. Todos los pacientes presentaron fiebre, el 45% irritabilidad, el 18,6% exantema y el 14% diarrea. No se observa ninguna alteración específica en las pruebas bioquímicas. El diagnóstico final más frecuente fue FSF (61%) seguido de sepsis clínica (29%). Aunque un 29% de los niños precisaron ingreso en cuidados intensivos, solo un paciente presentó secuelas. Conclusiones: Los HPeV circulan en nuestro país, afectando fundamentalmente a lactantes < 2 meses y se asocian a FSF y sepsis clínica, con un predominio en primavera y verano. Sería de interés implementar las técnicas moleculares de diagnóstico en todos los hospitales para reconocer y manejar adecuadamente estas infecciones.

The Spanish Association of Paediatric (AEP) has, among its objectives, to develop activities aimed at the training of its members. Thus, in 2013, it began its most ambitious training project, the virtual platform, “Continuum”. Now it presents a new section aimed at Internal Medicine Residents (MIR) in Paediatrics and their tutors: “I Prepare My Rotation By”-PMRP, which has as objectives to reduce the variation in MIR training, to help the tutors in their teaching function, to facilitate collaborative and skill-based learning, reflective training, and the resolving of the particular problems of the professional profile of each paediatric speciality.PMRP is split into three main sections: “From where do we start” (with the sub-sections: self-assessment questionnaire and learning agreement), “Situations to resolve” (where the clinical scenarios that have been selected in the learning agreement are broken down), and “To where have we got” (which includes again the sub-sections at the beginning of the rotation in order to check if the expected objectives have been reached, and the assessment report). It also has other resources: prior knowledge, portfolio, and discussion forum.Five features of the proposed training model should be highlighted: the clinical scenario as a starting point; skill-based learning (based on the Global Paediatric Educational Consortium); the assessment as a training stimulus; the power of collaborative learning, and the participation of the different specialist societies of the AEP in the development of its contents. Resumen: La Asociación Española de Pediatría (AEP) tiene entre sus objetivos desarrollar actividades encaminadas a la formación de sus socios. Así, en 2013 puso en marcha su proyecto formativo más ambicioso, la plataforma de formación virtual, “Continuum”. Se presenta ahora una nueva sección dirigida a los Médicos Internos Residentes (MIR) en Pediatría y a sus tutores: “Preparo Mi Rotación Por”- PMRP -, que tiene como propósitos disminuir la variabilidad en la formación de los MIR, asistir a los tutores en su función docente, facilitar el aprendizaje colaborativo y basado en competencias, el entrenamiento reflexivo y la resolución de problemas propios del perfil profesional de cada especialidad pediátrica.PMRP se distribuye en tres secciones principales: “De dónde partimos” (con las subsecciones: cuestionario de autoevaluación y contrato de aprendizaje), “Situaciones a resolver” (donde se desglosan los escenarios clínicos que han sido escogidos en el contrato de aprendizaje) y “A dónde llegamos” (que vuelve a incluir las subsecciones del comienzo de la rotación, para comprobar si los objetivos previstos han sido alcanzados, y el informe de evaluación). Además, cuenta con otros recursos: conocimientos previos, porfolio y foro de debate.Cabe destacar cinco aspectos del modelo formativo propuesto esta nueva sección: el escenario clínico como punto de partida; el aprendizaje basado en competencias (fundamentado en el Global Pediatric Educational Consortium); la evaluación como estímulo de formación; el poder del aprendizaje colaborativo y la participación de las diferentes sociedades de especialidad de la AEP en el desarrollo de sus contenidos.

Resumen: Introducción: En España no existen presentaciones pediátricas de fármacos antituberculosos, salvo para rifampicina. Algunos pediatras prescriben fórmulas magistrales (FM), mientras que otros administran comprimidos triturados. No existe consenso al respecto, ni estudios de farmacocinética que avalen estos procedimientos. Ante esta situación, la Red Española de Estudio de la Tuberculosis Pediátrica (pTBred) desarrolla el Proyecto Magistral, con el objetivo de analizar, en su primera fase, la conveniencia de desarrollar formas farmacéuticas específicas para niños, así como estudiar otros aspectos relacionados con la administración de antituberculosos en niños. Material y métodos: Estudio transversal, multicéntrico y de ámbito nacional, mediante encuesta on-line enviada por correo electrónico a los instituciones pertenecientes a pTBred entre febrero y marzo del 2015 Resultados: Se recibieron 54 respuestas de 67 instituciones consultadas. La mayoría de los centros trituran los comprimidos. Un porcentaje elevado, aunque menor, administra FM, cuya disponibilidad es variable entre las instituciones. El 83% responde que sería ideal disponer de combinaciones fijas de antituberculosos, adaptadas a las dosis pediátricas y administradas mediante FM o en un comprimido. Entre las instituciones encuestadas existen diferencias en el tratamiento de la infección tuberculosa latente, el uso de la terapia directamente observada y la monitorización de efectos adversos. Conclusiones: Nuestra encuesta revela gran heterogeneidad en la prescripción de antituberculosos en niños debido a la falta de formulaciones específicas para esta edad, que podría tener implicaciones en la adherencia al tratamiento y evolución. pTBred propone elaborar un pionero y útil documento de consenso sobre la administración de medicación antituberculosa en niños. Abstract: Introduction: There are no paediatric formulations of anti-tuberculous drugs in Spain, with the only exception being rifampicin. Some paediatricians often prescribe composite formulations (CF), while others prefer to give crushed tablets. Nevertheless, there is no consensus in this regard, or any pharmacokinetic studies validating these procedures. In this situation, the Spanish Network for the Study of Paediatric Tuberculosis (pTBred) has launched the Magistral Project, which has as its first phase aims to analyse the desirability of developing child-friendly pharmaceutical formulations and other aspects regarding the anti-tuberculous drug prescription in children. Material and methods: A cross-sectional, multicentre, nationwide study was conducted, based on an online questionnaire sent to members of pTBred between February and March 2015. Results: Fifty-four responses from 67 consulted institutions were received. Most of the respondents reported prescribing crushed tablets. A significant number of those surveyed, although being fewer, prescribe CF, for which availability varies widely among institutions. Eighty-three percent replied that it would be essential to have fixed dose combinations of anti-tuberculous drugs, specifically adapted to paediatric doses and administered by CF or tablets. Among the surveyed institutions, differences were found in the management of latent tuberculosis infection, in the use of directly observed therapy, and in the monitoring of adverse events. Conclusions: Our survey reveals great diversity in anti-tuberculous drug prescription in children, due to the lack of suitable infant formulations, which could have an impact on treatment adherence and outcomes. pTBred intends to develop a pioneering and useful consensus document on the management of anti-tuberculous medication in children.

There are only a limited number of studies on the impact of influenza in the Spanish child population. The present work intends to increase this knowledge by studying some key aspects, such as the incidence of hospital admissions, clinic variables, comorbidities, and the vaccination status in the hospitalised children.A retrospective, observational study was conducted by reviewing the medical records of children under 15 years and hospitalised due to community acquired influenza confirmed microbiologically, during 2́flu seasons (2014-2015 and 2015-2016). The study was carried out in 10 hospitals of 6cities, which represent approximately 12% of the Spanish child population.A total of 907 children were admitted to hospital with main diagnosis of influenza infection (4472 years), estimating an average annual rate of hospitalisation incidence of 0.51 cases / 1,000 children (95% CI; 0.48-0.55). Just under half (45%) of the cases had an underlying disease considered a risk factor for severe influenza, and most (74%) had not been vaccinated. The percentage of children with underlying diseases increased with age, from 26% in children6 months to 74% in children10 years. Admission to the PICU was required in 10% (92) of the cases, mainly due to acute respiratory failure.Influenza continues to be an important cause of hospitalisation in the Spanish child population. Children6 months of age and children with underlying diseases make up the majority (50%) of the cases. Many of the severe forms of childhood influenza that occur today could be avoided if current vaccination guidelines were met.

Tuberculosis (TB) is the most important infectious disease all over the world, with a high morbidity and mortality. Paediatric tuberculosis has been a neglected epidemic, due to the difficulties in assessing its global impact, reduced incidence and lower infectivity compared to adults. In 2015, the WHO reported 1 million cases of paediatric TB and 169,000 deaths. In Europe, the emergence of MDR TB is a major concern, representing 16% of the new diagnosis in Eastern Europe. In 2014, it was estimated that about 219,000 children were infected by MDR-TB-strains in Europe, and 2120 developed the disease. Spain is the Western European country with more paediatric cases, with an incidence 4.3/100,000 inhabitants in 2014. Paediatric tuberculosis mortality in Spain is rare, but extra-pulmonary disease is associated with significant complications. The prevalence of paediatric drug resistant TB in Spain is over 4%, higher than the estimated incidence in adult population, representing mayor difficulties for therapeutic intervention. These data reveal that paediatric TB is still a Public Health priority in our country.The difficulties in diagnosis and the lack of optimal paediatric drug formulations are the major challenges for controlling the childhood's tuberculosis epidemic. A group of national paeditric TB experts has reviewed the international guidelines and the most recent evidences, and has established new recommendations for the management of paediatric TB contacts, latent infection and active TB disease, especially focused in drug resistant cases. This document replaces the former national guidelines from the Spanish Society for Pediatric Infectious Diseases, although the prior recommendations on the diagnosis remain valid. Resumen: La tuberculosis (TB) es la enfermedad infecciosa más importante del mundo, asociando enorme morbimortalidad. La TB pediátrica ha sido una epidemia oculta por su escasa capacidad infectiva y menor incidencia comparada con adultos. El informe-OMS 2015 estimó un millón de niños enfermos de TB en el mundo y 169.000 fallecidos. En Europa, el problema acuciante es la tuberculosis multirresistente, con tasas del 16% en nuevos diagnósticos, especialmente en países del este. En 2014, 219.000 niños se infectaron por cepas-MDR en Europa, 2.120 desarrollaron enfermedad. España es el país de Europa con mayor número de casos pediátricos, con una incidencia en 2014: 4,3/100.000 habitantes. La mortalidad por TB pediátrica en nuestro país es excepcional, pero las formas extrapulmonares ocasionan importantes complicaciones. La TB resistente en niños en España presenta una prevalencia >4%, superando incluso la notificada en adultos. Estos datos reflejan que la TB en niños en nuestro medio continúa siendo un problema de salud pública prioritario.Las dificultades diagnósticas del niño y la falta de formulaciones pediátricas óptimas son el mayor desafío para control de TB infantil. El Grupo de expertos de TB pediátrica realiza un análisis de las nuevas tendencias internacionales y guías terapéuticas de tuberculosis en niños, según nuevas evidencias disponibles; y considera una prioridad actualizar las guías pediátricas nacionales de exposición a TB, infección tuberculosa latente y enfermedad, y particularmente los casos de resistencia a fármacos. Este documento, por tanto, sustituye a todos los previos en cuanto a las pautas terapéuticas, aunque siguen estando vigentes las indicaciones diagnósticas.

Resumen: La tuberculosis (TB) es la enfermedad infecciosa más importante del mundo, asociando enorme morbimortalidad. La TB pediátrica ha sido una epidemia oculta por su escasa capacidad infectiva y menor incidencia comparada con adultos. El informe-OMS 2015 estimó un millón de niños enfermos de TB en el mundo y 169.000 fallecidos. En Europa, el problema acuciante es la tuberculosis multirresistente, con tasas del 16% en nuevos diagnósticos, especialmente en países del este. En 2014, 219.000 niños se infectaron por cepas-MDR en Europa, 2.120 desarrollaron enfermedad. España es el país de Europa con mayor número de casos pediátricos, con una incidencia en 2014: 4,3/100.000 habitantes. La mortalidad por TB pediátrica en nuestro país es excepcional, pero las formas extrapulmonares ocasionan importantes complicaciones. La TB resistente en niños en España presenta una prevalencia > 4%, superando incluso la notificada en adultos. Estos datos reflejan que la TB en niños en nuestro medio continúa siendo un problema de salud pública prioritario.Las dificultades diagnósticas del niño y la falta de formulaciones pediátricas óptimas son el mayor desafío para control de TB infantil. El Grupo de expertos de TB pediátrica realiza un análisis de las nuevas tendencias internacionales y guías terapéuticas de tuberculosis en niños, según nuevas evidencias disponibles; y considera una prioridad actualizar las guías pediátricas nacionales de exposición a TB, infección tuberculosa latente y enfermedad, y particularmente los casos de resistencia a fármacos. Este documento, por tanto, sustituye a todos los previos en cuanto a las pautas terapéuticas, aunque siguen estando vigentes las indicaciones diagnósticas. Abstract: Tuberculosis (TB) is the most important infectious disease all over the world, with a high morbidity and mortality. Pediatric tuberculosis has been a neglected epidemic, due to the difficulties in assessing its global impact, reduced incidence and lower infectivity compared to adults. In 2015, the WHO reported 1 million cases of paediatric TB and 169,000 deaths. In Europe, the emergence of MDR TB is a major concern, representing 16% of the new diagnosis in Eastern Europe. In 2014, it was estimated that about 219,000 children were infected by MDR-TB-strains in Europe, and 2,120 developed the disease. Spain is the Western European country with more paediatric cases, with an incidence 4.3/100,000 inhabitants in 2014. Paediatric tuberculosis mortality in Spain is rare, but extra-pulmonary disease is associated with significant complications. The prevalence of paediatric drug resistant TB in Spain is over 4%, higher than the estimated incidence in adult population, representing mayor difficulties for therapeutic intervention. These data reveal that paediatric TB is still a Public Health priority in our country.The difficulties in diagnosis and the lack of optimal paediatric drug formulations are the major challenges for controlling the childhood's tuberculosis epidemic. A group of national paeditric TB experts has reviewed the international guidelines and the most recent evidences, and has established new recommendations for the management of paediatric TB contacts, latent infection and active TB disease, especially focused in drug resistant cases. This document replaces the former national guidelines from the Spanish Society for Pediatric Infectios Diseases, although the prior recommendations on the diagnosis remain valid.

Introduction: Off-label drug use is a common practice in paediatrics. The aim of the present study was to estimate the knowledge of Spaniard paediatricians on off-label use. Materials and methods: Cross-sectional, multicentre, descriptive and national study from July 2012 to March 2013 using an on-line questionnaire on off-label use in children. An e-mail was sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP) or its Regional or Paediatric Specialties Societies. Results: Out of 673 responses received, 75.1% of Spanish paediatricians knew the meaning of off-label use, 61% of them prescribed medicines outside the conditions authorised in their Summary of Product Characteristics (SPC) and 47% knew of the importance of noting the off-label use in the medical record. However, just under half of paediatricians informed parents, and only 22% wrote it down in the medical record. Conclusions: Most Spanish paediatricians do not meet current regulations regarding off-label use. This regulation demands: justifying the decisions when off-label use is needed, and to write down in the medical record that, at least an oral consent from the parents has been obtained. This study reveals a fact that Spanish paediatricians must change. Meanwhile, it is a priority to continue with the implementation of consensus and clinical guidelines, to obtain more data on the efficacy and safety of off-label drug use in children, and to incorporate them into the SPC. Resumen: Introducción: Un número elevado de fármacos se prescriben en niños bajo condiciones no autorizadas en ficha técnica (uso off-label). El objetivo principal del estudio es estimar el conocimiento sobre el uso de fármacos fuera de ficha técnica por parte de los pediatras españoles. Material y métodos: Estudio transversal, multicéntrico, descriptivo, de ámbito nacional, mediante encuesta on-line, enviada por correo electrónico a pediatras socios de la Asociación Española de Pediatría o de sus sociedades de Especialidades y Regionales, entre julio del 2012 y marzo del 2013. Resultados: Se recibieron 673 respuestas. Un 71,5% de los pediatras españoles conocen el significado del término off-label, el 61% afirma que prescribe fármacos con indicaciones fuera de ficha técnica y un 47% conoce que dicho uso debe quedar reflejado en la historia clínica. Sin embargo, algo menos de la mitad informa a los padres y solo el 22% lo deja anotado en la historia clínica. Conclusiones: Muchos pediatras no cumplen con la normativa actual con respecto al uso de fármacos en condiciones no autorizadas en ficha técnica. Esta normativa exige: justificar las decisiones de uso off-label y registrar en la historia clínica que se ha obtenido el consentimiento, al menos verbal, de los padres. Se pone de manifiesto una realidad que los pediatras españoles deben cambiar. Mientras tanto, es prioritario continuar con la realización de documentos de consenso y guías de práctica clínica para ampliar la información sobre la eficacia y seguridad de los usos off-label en niños, y poder incorporarlos a las fichas técnicas autorizadas.

Resumen: La Asociación Española de Pediatría (AEP) tiene entre sus objetivos desarrollar actividades encaminadas a la formación de sus socios. Así, en 2013 puso en marcha su proyecto formativo más ambicioso, la plataforma de formación virtual «Continuum». Se presenta ahora una nueva sección dirigida a los médicos internos residentes (MIR) en Pediatría y a sus tutores: «Preparo Mi Rotación Por» (PMRP), que tiene como propósitos disminuir la variabilidad en la formación de los MIR, asistir a los tutores en su función docente, facilitar el aprendizaje colaborativo y basado en competencias, el entrenamiento reflexivo y la resolución de problemas propios del perfil profesional de cada especialidad pediátrica.PMRP se distribuye en tres secciones principales: «De dónde partimos» (con las subsecciones: cuestionario de autoevaluación y contrato de aprendizaje), «Situaciones a resolver» (donde se desglosan los escenarios clínicos que han sido escogidos en el contrato de aprendizaje) y «A dónde llegamos» (que vuelve a incluir las subsecciones del comienzo de la rotación, para comprobar si los objetivos previstos han sido alcanzados, y el informe de evaluación). Además, cuenta con otros recursos: conocimientos previos, porfolio y foro de debate.Cabe destacar cinco aspectos del modelo formativo propuesto en esta nueva sección: el escenario clínico como punto de partida; el aprendizaje basado en competencias (fundamentado en el Global Pediatric Educational Consortium); la evaluación como estímulo de formación; el poder del aprendizaje colaborativo, y la participación de las diferentes sociedades de especialidad de la AEP en el desarrollo de sus contenidos. Abstract: The Spanish Paediatric Association (AEP) has, among its objectives, to develop activities aimed at the training of its members. Thus, in 2013, it began its most ambitious training project, the virtual platform, «Continuum». Now it presents a new section aimed at Internal Medicine Residents (MIR) in Paediatrics and their tutors: «I Prepare My Rotation By» (PMRP), which has as objectives to reduce the variation in MIR training, to help the tutors in their teaching function, to facilitate collaborative and skill-based learning, reflective training, and the resolving of the particular problems of the professional profile of each paediatric speciality.PMRP is split into three main sections: «From where do we start» (with the sub-sections: self-assessment questionnaire and learning agreement), «Situations to resolve» (where the clinical scenarios that have been selected in the learning agreement are broken down), and «To where have we got» (which includes again the sub-sections at the beginning of the rotation in order to check if the expected objectives have been reached, and the assessment report). It also has other resources: prior knowledge, portfolio, and discussion forum.Five features of the proposed training model should be highlighted: the clinical scenario as a starting point; skill-based learning (based on the Global Paediatric Educational Consortium); the assessment as a training stimulus; the power of collaborative learning, and the participation of the different specialist societies of the AEP in the development of its contents.

Resumen: La Red Española de Estudio de la Tuberculosis Pediátrica ha evidenciado una falta de consenso nacional en la administración de antituberculosos en niños, propiciada por la escasez de presentaciones pediátricas específicas. Es prioritario homogeneizar el tratamiento de la tuberculosis en niños en nuestro país. Un grupo de expertos españoles en tuberculosis infantil y en el área de medicamentos pediátricos proponen una actuación conjunta, con la finalidad de mejorar esta situación en nuestro medio. Para ello se constituye un Grupo de Trabajo, liderado por pTBred, en el que participan otras 5 sociedades e instituciones científicas. Se proponen las siguientes fórmulas magistrales en forma de suspensión o solución oral para el tratamiento de la tuberculosis en niños: isoniacida 50 mg/ml, pirazinamida 100 mg/ml y etambutol 50 mg/ml. Se especifican materias primas, periodo de validez y condiciones de conservación y administración. Se establecen recomendaciones para el uso de fármacos combinados a dosis fijas. Si no se consigue la dosis apropiada mediante fármacos combinados a dosis fijas, y no se dispone de fórmula magistral, se recomienda la administración mediante comprimidos triturados. El adecuado cumplimiento terapéutico y la administración de dosis óptimas de los fármacos antituberculosos constituyen pilares fundamentales en el control y erradicación de la enfermedad. La oportunidad de disponer de este documento multidisciplinar en España favorecerá el correcto tratamiento de la tuberculosis pediátrica, y será una guía útil para todos los pediatras y farmacéuticos que lo precisen. Abstract: The Spanish Network for the Study of Paediatric Tuberculosis has shown a lack of national consensus on the treatment of tuberculosis in children, partly due to the unavailability of paediatric presentations of antituberculosis drugs. The harmonisation of tuberculosis treatment in children is a priority in Spain. A joint action is proposed by a group of Spanish experts in childhood tuberculosis and in the area of Paediatric Pharmacology. To this end, a pTBred-led workgroup of members from five scientific bodies has been created. Drug pharmaceutical compounding in oral suspensions or oral solutions are recommended as follows: isoniazid 50 mg/mL, pyrazinamide 100 mg/mL, and ethambutol 50 mg/mL. Raw materials, period of validity, and storage conditions are specified. Recommendations for the use of fixed-dose combination drugs are also established. If oral solutions/suspensions or fixed-dose combination drugs are not appropriate, the use of crushed tablets is recommended. Adherence to treatment and optimal dosing of antituberculosis drugs are critical in the control and eradication of TB. This multidisciplinary document provides an opportunity to promote the appropriate treatment of paediatric tuberculosis in Spain, and should become a useful tool for paediatricians and pharmacists.

The aim of the study was to determine the incidence of viruses causing aseptic meningitis, meningoencephalitis, and encephalitis in Spain. This was a prospective study, in collaboration with 17 Spanish hospitals, including 581 cases (CSF from all and sera from 280): meningitis (340), meningoencephalitis (91), encephalitis (76), febrile syndrome (7), other neurological disorders (32), and 35 cases without clinical information. CSF were assayed by PCR for enterovirus (EV), herpesvirus (herpes simplex [HSV], varicella-zoster [VZV], cytomegalovirus [CMV], Epstein-Barr [EBV], and human herpes virus-6 [HHV-6]), mumps (MV), Toscana virus (TOSV), adenovirus (HAdV), lymphocytic choriomeningitis virus (LCMV), West Nile virus (WNV), and rabies. Serology was undertaken when methodology was available. Amongst meningitis cases, 57.1% were characterized; EV was the most frequent (76.8%), followed by VZV (10.3%) and HSV (3.1%; HSV-1: 1.6%; HSV-2: 1.0%, HSV non-typed: 0.5%). Cases due to CMV, EBV, HHV-6, MV, TOSV, HAdV, and LCMV were also detected. For meningoencephalitis, 40.7% of cases were diagnosed, HSV-1 (43.2%) and VZV (27.0%) being the most frequent agents, while cases associated with HSV-2, EV, CMV, MV, and LCMV were also detected. For encephalitis, 27.6% of cases were caused by HSV-1 (71.4%), VZV (19.1%), or EV (9.5%). Other positive neurological syndromes included cerebellitis (EV and HAdV), seizures (HSV), demyelinating disease (HSV-1 and HHV-6), myelopathy (VZV), and polyradiculoneuritis (HSV). No rabies or WNV cases were identified. EVs are the most frequent cause of meningitis, as is HSV for meningoencephalitis and encephalitis. A significant number of cases (42.9% meningitis, 59.3% meningoencephalitis, 72.4% encephalitis) still have no etiological diagnosis. Grant sponsor: Fondo de Investigación Sanitaria, Instituto de Salud Carlos III, Spanish Ministry of Economy and Competitiveness; Grant number: PI07/90154 Sí

Introduction: There are no paediatric formulations of anti-tuberculous drugs in Spain, with the only exception being rifampicin. Some paediatricians often prescribe composite formulations (CF), while others prefer to give crushed tablets. Nevertheless, there is no consensus in this regard, or any pharmacokinetic studies validating these procedures. In this situation, the Spanish Network for the Study of Paediatric Tuberculosis (pTBred) has launched the Magistral Project, which aims at its first phase to analyse the desirability of developing child-friendly pharmaceutical formulations and other aspects regarding the anti-tuberculous drug prescription in children. Material and methods: A cross-sectional, multicentre, nationwide study was conducted, based on an online questionnaire sent to members of pTBred between February and March 2015. Results: Fifty-four responses from 67 consulted institutions were received. Most of the respondents reported prescribing crushed tablets. A significant number of those surveyed, although being fewer, prescribe CF, for which availability varies widely among institutions. Eighty-three percent replied that it would be essential to have fixed dose combinations of anti-tuberculous drugs, specifically adapted to paediatric doses and administered by CF or tablets. Among the surveyed institutions, differences were found in the management of latent tuberculosis infection, in the use of directly observed therapy, and in the monitoring of adverse events. Conclusions: Our survey reveals great diversity in anti-tuberculous drug prescription in children, due to the lack of suitable infant formulations, which could have an impact on treatment adherence and outcomes. pTBred intends to develop a pioneering and useful consensus document on the management of anti-tuberculous medication in children. Resumen: Introducción: En España no existen presentaciones pediátricas de fármacos antituberculosos, salvo para rifampicina. Algunos pediatras prescriben fórmulas magistrales (FM), mientras que otros administran comprimidos triturados. No existe consenso al respecto, ni estudios de farmacocinética que avalen estos procedimientos. Ante esta situación, la Red Española de Estudio de la Tuberculosis Pediátrica (pTBred) desarrolla el Proyecto Magistral, con el objetivo de analizar, en su primera fase, la conveniencia de desarrollar formas farmacéuticas específicas para niños, así como estudiar otros aspectos relacionados con la administración de antituberculosos en niños. Material y métodos: Estudio transversal, multicéntrico y de ámbito nacional, mediante encuesta on-line enviada por correo electrónico a los instituciones pertenecientes a pTBred entre febrero y marzo del 2015. Resultados: Se recibieron 54 respuestas de 67 instituciones consultadas. La mayoría de los centros trituran los comprimidos. Un porcentaje elevado, aunque menor, administra FM, cuya disponibilidad es variable entre las instituciones. El 83% responde que sería ideal disponer de combinaciones fijas de antituberculosos, adaptadas a las dosis pediátricas y administradas mediante FM o en un comprimido. Entre las instituciones encuestadas existen diferencias en el tratamiento de la infección tuberculosa latente, el uso de la terapia directamente observada y la monitorización de efectos adversos. Conclusiones: Nuestra encuesta revela gran heterogeneidad en la prescripción de antituberculosos en niños debido a la falta de formulaciones específicas para esta edad, que podría tener implicaciones en la adherencia al tratamiento y evolución. pTBred propone elaborar un pionero y útil documento de consenso sobre la administración de medicación antituberculosa en niños.

En los últimos años se han producido grandes avances en la atención de los niños con infección por el virus de la inmunodeficiencia humana (VIH), sobre todo en el tratamiento antirretroviral, que se ha traducido en un aumento en la supervivencia y en la calidad de vida. El objetivo que se pretende con el tratamiento antirretroviral de gran actividad (TARGA), consistente en la combinación de al menos tres fármacos potentes, es la máxima y más duradera supresión de la replicación viral, lo cual no siempre es posible, a pesar de lo cual existe una mejoría inmunológica y clínica franca. Persisten grandes obstáculos para conseguir y mantener una máxima supresión de la replicación viral a largo plazo, entre los que se destacan la dificultad de adherencia permanente, con regímenes complejos y la posible toxicidad de la medicación. Los efectos adversos del tratamiento son frecuentes, siendo preocupante la elevada prevalencia de complicaciones metabólicas con unas consecuencias futuras desconocidas. Estas dificultades están motivando una tendencia actual para el inicio del tratamiento más conservadora, así como la implementación de estrategias con opciones terapéuticas simplificadas y con menor toxicidad. Es necesario continuar el desarrollo de fármacos que permitan vencer las todavía importantes limitaciones del tratamiento antirretroviral actual. : In recent years, major advances have been made in the care of HIV-infected children, particularly in antiretroviral treatment, which have dramatically improved survival and quality of life. The goal of highly active antiretroviral therapy (HAART), which includes at least three potent drugs, is the maximal and most durable suppression of viral replication possible, which is often not achieved despite clear immunologic and clinical improvement. There are still major barriers to achieving this goal, mainly the difficulty of permanent adherence to complex regimens and treatment-related toxicities. Adverse events are frequent, including a high prevalence of metabolic complications with unknown consequences in the future. These drawbacks of antiretroviral treatment are leading to a more conservative initial approach, as well as to research into simpler and less toxic therapeutic options. New strategies should continue to be developed to overcome the still important limitations of current antiretroviral treatment.

The Spanish Network for the Study of Paediatric Tuberculosis has shown a lack of national consensus on the treatment of tuberculosis in children, partly due to the unavailability of paediatric presentations of antituberculosis drugs. The harmonisation of tuberculosis treatment in children is a priority in Spain. A joint action is proposed by a group of Spanish experts in childhood tuberculosis and in the area of Paediatric Pharmacology. To this end, a pTBred-led workgroup of members from five scientific bodies has been created. Drug pharmaceutical compounding in oral suspensions or oral solutions are recommended as follows: isoniazid 50 mg/mL, pyrazinamide 100 mg/mL, and ethambutol 50 mg/mL. Raw materials, period of validity, and storage conditions are specified. Recommendations for the use of fixed-dose combination drugs are also established. If oral solutions/suspensions or fixed-dose combination drugs are not appropriate, the use of crushed tablets is recommended. Adherence to treatment and optimal dosing of antituberculosis drugs are critical in the control and eradication of TB. This multidisciplinary document provides an opportunity to promote the appropriate treatment of paediatric tuberculosis in Spain, and should become a useful tool for paediatricians and pharmacists. Resumen: La Red Española de Estudio de la Tuberculosis Pediátrica ha evidenciado una falta de consenso nacional en la administración de antituberculosos en niños, propiciada por la escasez de presentaciones pediátricas específicas. Es prioritario homogeneizar el tratamiento de la tuberculosis en niños en nuestro país. Un grupo de expertos españoles en tuberculosis infantil y en el área de medicamentos pediátricos proponen una actuación conjunta, con la finalidad de mejorar esta situación en nuestro medio. Para ello se constituye un Grupo de Trabajo, liderado por pTBred, en el que participan otras 5 sociedades e instituciones científicas. Se proponen las siguientes fórmulas magistrales en forma de suspensión o solución oral para el tratamiento de la tuberculosis en niños: isoniacida 50 mg/ml, pirazinamida 100 mg/ml y etambutol 50 mg/ml. Se especifican materias primas, periodo de validez y condiciones de conservación y administración. Se establecen recomendaciones para el uso de fármacos combinados a dosis fijas. Si no se consigue la dosis apropiada mediante fármacos combinados a dosis fijas, y no se dispone de fórmula magistral, se recomienda la administración mediante comprimidos triturados. El adecuado cumplimiento terapéutico y la administración de dosis óptimas de los fármacos antituberculosos constituyen pilares fundamentales en el control y erradicación de la enfermedad. La oportunidad de disponer de este documento multidisciplinar en España favorecerá el correcto tratamiento de la tuberculosis pediátrica, y será una guía útil para todos los pediatras y farmacéuticos que lo precisen.

Human parechoviruses (HPeV) have been recently recognized as important viral agents in paediatric infections. The aims of this study were to investigate the HPeV infection prevalence in infants

In the last years, inhibitors of tumor necrosis factor alpha (antiTNFα) have been a major advance in the treatment of many rheumatic diseases and inflammatory bowel disease, also in the pediatric patient. However, antiTNFα use is associated with an increased risk of serious infections, including tuberculosis (TB). In adults, the new interferon γ release assays (IGRA) tests for the diagnosis of TB infection appear to show better sensitivity and specificity than the tuberculin skin test (TST) in these patients. Data in children are still very scarce. We have previously reported a latent tuberculosis infection (LTI) prevalence rate of 1.4% (95%CI: 0-2.9) in children on antiTNFα treatment, which is similar to that reported in healthy pediatric population studies in Spain. LTI was diagnosed in 3 adolescent girls (out of 221 patients) in whom QTF tested positive, while TST was positive in only one of them.