Influencia de la fracción inspiratoria de oxígeno en la reanimación del recién nacido prematuro: ensayo clínico doble ciego

La reanimación de recién nacidos con 100% de oxígeno se asocia con aumento de la morbilidad y la mortalidad relacionada con hiperoxemia; por lo tanto, las guías de reanimación actuales aconsejan iniciar la reanimación de recién nacidos a término con aire ambiente. Los estudios clínicos y experimentales han mostrado un retraso en el inicio del esfuerzo respiratorio en pacientes que reciben alta concentraciones de oxígeno suplementario. La fracción óptima de oxígeno inspirado (FiO2) a la cual comenzar la reanimación de recién nacidos prematuros sigue siendo desconocida. Se han publicado estudios pequeños comparado FiO2 de 0,21 vs 1 en la reanimación de recién nacidos prematuros. Entre sus resultados cabe destacar que se precisó aumentar la FiO2 en los grupos de bajo oxígeno para alcanzar una saturación de oxígeno (SpO2) objetivo, lo que sugiere que la reanimación inicial de recién nacidos prematuros con aire ambiente podría resultar insuficiente. Asimismo, la FiO2 se redujo en los grupos de alto oxígeno en base a los objetivos de SpO2. Por tanto, nuestro objetivo fue evaluar la seguridad y eficacia de iniciar la reanimación de recién nacidos prematuros con una FiO2 intermedia. La hipótesis de trabajo es que comenzar la reanimación de recién nacidos prematuros (EG <30 semanas) con una FiO2 inicial de 0,3 disminuiría la tasa de intubación en la sala de partos en comparación con una FiO2 inicial de 0,6. Objetivo: Comprobar la hipótesis de que una FiO2 de 0,3 durante la reanimación de recién nacidos prematuros se traduce en menos estrés oxidativo y se asocia con mejores resultados clínicos en comparación con una FiO2 de 0,6. Diseño del estudio: Ensayo aleatorio doble ciego. Los recién nacidos prematuros de edad gestacional <30 semanas (n = 60) fueron asignados al azar a comenzar la reanimación con 30% de oxígeno (grupo de bajo oxígeno) o con 60% de oxígeno (grupo de alto oxígeno), después de lo cual la FiO2 se ajustó en función de los valores de saturación de oxígeno. Se utilizó un sistema de monitorización integral destinado a recoger en tiempo real los signos vitales de los recién nacidos, así como las concentraciones de oxígeno administradas durante la reanimación. La variable principal fue la tasa de intubación en la sala de partos. Los resultados secundarios incluyeron las principales enfermedades neonatales y marcadores de estrés oxidativo en sangre y orina. Resultados: La tasa de intubación no fue significativamente diferente entre los grupos de alto oxígeno y de bajo oxígeno (32,4% vs 20%, p = NS). Se precisó un aumento inicial de la FiO2 en todos los pacientes, excepto en dos (94,2%) en el grupo de bajo oxígeno. La FiO2 en ambos grupos se ajustó a una media de 0,4 alrededor de los 5 minutos en el grupo de bajo oxígeno y en torno a los 7 minutos en el grupo de alto oxígeno. No se observaron diferencias significativas en el resto de objetivos secundarios ni en los marcadores de estrés oxidativo entre ambos grupos. Conclusiones: El inicio de la reanimación en recién nacidos prematuros con una FiO2 de 0,3 es tan seguro como 0,6 de oxígeno, en términos de tasa de intubación y en marcadores de estrés oxidativo. La necesidad de incremento de la FiO2 en el grupo de bajo oxígeno hace necesario considerar que concentraciones iniciales más altas pueden conducir al logro más precoz de las saturaciones fisiológicas consideradas como objetivo.Resuscitation of infants at birth with 100% oxygen is associated with increased morbidity and mortality related to hyperoxemia; thus, current resuscitation guidelines advise starting the resuscitation of term infants with air. Clinical and experimental studies have shown a delay in the initiation of the respiratory effort in patients receiving high supplementary oxygen. The optimal fraction of inspired oxygen (FiO2) at which to start resuscitation of preterm infants remains unknown. Small studies on FiO2 for the resuscitation of preterm infants have compared FiO2 of 0,21 vs. 1. In those studies, FiO2 was increased in the low-oxygen groups according to oxygen saturation (SpO2) targets, suggesting that starting resuscitation of preterm infants with room air might provide insufficient oxygen. FiO2 was decreased in the high-oxygen groups based on the SpO2 targets. Thus, we aimed to assess the safety and efficacy of starting the resuscitation of preterm infants with an intermediate FiO2. We hypothesized that starting the resuscitation of preterm infants (GA <30 weeks) with an initial FiO2 of 0,3 would decrease the intubation rate at delivery room compared with an initial FiO2 of 0,6. Objective: To test the hypothesis that an initial FiO2 of 0,3 during resuscitation of preterm infants results in less oxidative stress and is associated with improved clinical outcomes compared with a FiO2 of 0,6. Study design: Double blind randomized trial. Preterm infants of gestational age <30 weeks (n = 60) were randomized to start resuscitation with either 30% oxygen (low-oxygen group) or 60% oxygen (high-oxygen group), after which the FiO2 was adjusted based on oxygen saturation values. Comprehensive monitoring system intended to collect real-time vital signs of newborns, as well as the concentrations of oxygen administered during resuscitation was used. The primary outcome was intubation in the delivery room. Secondary outcomes included major neonatal illnesses and blood and urine markers of oxidative stress. Results: The intubation rate was not significantly different between the low-oxygen and high-oxygen groups (32,4% vs 20%; p = NS). An initial FiO2 increase in all patients but two (94.2%) was needed in the low-oxygen group. The FiO2 in both groups was adjusted to a mean of 0,4 by 5 minutes in the low-oxygen group and by 7 minutes in the high-oxygen group. No differences in other secondary outcomes or markers of oxidative stress were noted between groups. Conclusion: Initial supplementation of preterm infants with 0,3 oxygen during the fetal-to-neonatal transition is as safe as 0,6 oxygen, with no differences in oxidative stress markers or intubation rate. The need of FiO2 increment in the low-oxygen group does consider that higher initial concentrations can lead to earlier achievement of the physiological targeted saturations

Digitalización y gestión de la infraestructura de recarga del vehículo eléctrico para su integración eficiente en la red de distribución

[ES] La integración del vehículo eléctrico (EV) es una pieza clave en la transición energética. Sin embargo, una alta penetración del EV supone un incremento de la demanda eléctrica con posibles consecuencias negativas sobre las redes de distribución. Para evitarlo, es necesario digitalizar las infraestructuras de recarga para ofrecer mecanismos de carga controlada con el objetivo de minimizar el impacto en la red y gestionar de manera activa y eficiente los recursos. En este artículo se presenta un piloto real de recarga con mecanismos de monitorización y de control de carga, en el que se muestran las ventajas de tener una infraestructura monitorizada, digitalizada y gestionada, así como los efectos que esto tiene sobre la red.La elaboración de este artículo se llevó a cabo en el marco de la red de Centros de Excelencia HySGrid+, con el título Desarrollo de comunidades locales energéticamente positivas con sistemas híbridos de generación renovable y almacenamiento financiado por el Ministerio de Ciencia, Innovación y Universidades a través del organismo CDTI, en el programa CER-20191019. Los autores agradecen la contribución del Instituto Valenciano de Competitividad Empresarial y del Fondo de Desarrollo Regional Europeo por hacer posible los desarrollos, permitiendo a ITE la difusión de los resultados y facilitando y promoviendo la transferencia de conocimiento a las empresas.Calatayud Martí, P.; Montagud Aguar, M.; Arcos Usero, L.; Romero-Chavarro, JC.; García Pellicer, M. (2020). Digitalización y gestión de la infraestructura de recarga del vehículo eléctrico para su integración eficiente en la red de distribución. Grupo Tecma Red. 138-143. http://hdl.handle.net/10251/178592S13814

Effects of Sepsis on Immune Response, Microbiome and Oxidative Metabolism in Preterm Infants

This is a narrative review about the mechanisms involved in bacterial sepsis in preterm infants, which is an illness with a high incidence, morbidity, and mortality. The role of the innate immune response and its relationship with oxidative stress in the pathogenesis are described as well as their potential implementation as early biomarkers. Moreover, we address the impact that all the mechanisms triggered by sepsis have on the dysbiosis and the changes on neonatal microbiota

Planificación del dimensionado, localización y operación óptima de sistemas de almacenamiento de energía en redes de distribución

[ES] El almacenamiento de energía distribuido puede desempeñar un papel clave en el funcionamiento de los futuros sistemas de energía con bajas emisiones de carbono, ya que pueden ayudar a facilitar la provisión de la flexibilidad necesaria para hacer frente a la intermitencia y volatilidad que presenta la generación renovable. En este contexto, este trabajo aborda una metodología de optimización que permite planificar y gestionar sistemas de almacenamiento distribuido de diferentes tecnologías y características en una red de distribución, teniendo en cuenta no solo los aspectos técnicos de la red y de los sistemas de almacenamiento sino también la incertidumbre vinculada a la variabilidad de la demanda y la generación renovable.Esta investigación ha sido financiada por el Fondo Europeo de Desarrollo Regional y el convenio de colaboración ITEIVACE correspondiente a la anualidad 2019. Este trabajo se ha realizado en el marco de HySGrid +, una red española de Centros de Excelencia que cuenta con el apoyo del Ministerio de Ciencia e Innovación a través del organismo CDTI, en el marco del programa Cervera "CER-20191019.Belinchón Calderón, A.; Escoto Simó, M.; González-Cobos, N.; Montagud Aguar, M.; Valentina Trujillo, A.; García Pellicer, M. (2020). Planificación del dimensionado, localización y operación óptima de sistemas de almacenamiento de energía en redes de distribución. Grupo Tecma Red. 70-75. http://hdl.handle.net/10251/178593S707

Survey of transfusion practices in preterm infants in Europe

BACKGROUND Preterm infants commonly receive red blood cell (RBC), platelet and fresh frozen plasma (FFP) transfusions. The aim of this Neonatal Transfusion Network survey was to describe current transfusion practices in Europe and to compare our findings to three recent randomised controlled trials to understand how clinical practice relates to the trial data. METHODS From October to December 2020, we performed an online survey among 597 neonatal intensive care units (NICUs) caring for infants with a gestational age (GA) of <32 weeks in 18 European countries. RESULTS Responses from 343 NICUs (response rate: 57%) are presented and showed substantial variation in clinical practice. For RBC transfusions, 70% of NICUs transfused at thresholds above the restrictive thresholds tested in the recent trials and 22% below the restrictive thresholds. For platelet transfusions, 57% of NICUs transfused at platelet count thresholds above 25×10$^{9}$/L in non-bleeding infants of GA of <28 weeks, while the 25×10$^{9}$/L threshold was associated with a lower risk of harm in a recent trial. FFP transfusions were administered for coagulopathy without active bleeding in 39% and for hypotension in 25% of NICUs. Transfusion volume, duration and rate varied by factors up to several folds between NICUs. CONCLUSIONS Transfusion thresholds and aspects of administration vary widely across European NICUs. In general, transfusion thresholds used tend to be more liberal compared with data from recent trials supporting the use of more restrictive thresholds. Further research is needed to identify the barriers and enablers to incorporation of recent trial findings into neonatal transfusion practice

The CoDiNOS trial protocol: an international randomised controlled trial of intravenous sildenafil versus inhaled nitric oxide for the treatment of pulmonary hypertension in neonates with congenital diaphragmatic hernia

INTRODUCTION: Congenital diaphragmatic hernia (CDH) is a developmental defect of the diaphragm that impairs normal lung development, causing pulmonary hypertension (PH). PH in CDH newborns is the main determinant for morbidity and mortality. Different therapies are still mainly based on 'trial and error'. Inhaled nitric oxide (iNO) is often the drug of first choice. However, iNO does not seem to improve mortality. Intravenous sildenafil has reduced mortality in newborns with PH without CDH, but prospective data in CDH patients are lacking. METHODS AND ANALYSIS: In an open label, multicentre, international randomised controlled trial in Europe, Canada and Australia, 330 newborns with CDH and PH are recruited over a 4-year period (2018-2022). Patients are randomised for intravenous sildenafil or iNO. Sildenafil is given in a loading dose of 0.4 mg/kg in 3 hours; followed by continuous infusion of 1.6 mg/kg/day, iNO is dosed at 20 ppm. Primary outcome is absence of PH on day 14 without pulmonary vasodilator therapy and/or absence of death within the first 28 days of life. Secondary outcome measures include clinical and echocardiographic markers of PH in the first year of life. We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a sample size of 330 patients is needed. An intention-to-treat analysis will be performed. A p-value (two-sided) <0.05 is considered significant in all analyses. ETHICS AND DISSEMINATION: Ethics approval has been granted by the ethics committee in Rotterdam (MEC-2017-324) and the central Committee on Research Involving Human Subjects (NL60229.078.17) in the Netherlands. The principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act and the national rules and regulations on personal data protection will be used. Parental informed consent will be obtained. TRIAL REGISTRATION NUMBER: NTR6982; Pre-results

Validación de una escala para la medición de los malos tratos a mujeres

ObjetivosAnalizar la validez de contenido y de constructo, así como la fiabilidad de un cuestionario diseñado para medir los malos tratos (MT) a mujeres por parte de su pareja.DiseñoEstudio descriptivo, transversal y multicéntrico.EmplazamientoCuatro centros de salud urbanos de Granada.ParticipantesSe incluyó a 391 mujeres≥14 años que consultaron en atención primaria y con pareja estable al menos 3 meses.Mediciones principalesCuestionario mediante entrevista, entre diciembre de 2000 y mayo de 2001, con 10 preguntas tipo Likert sobre maltrato físico, psíquico y sexual, características sociodemográficas y varios indicadores de salud. Analizamos la validez del contenido mediante el análisis factorial exploratorio, la fiabilidad de los factores con el alfa de Cronbach, y los coeficientes de correlación ítem-escala corregidos, así como validez de constructo.ResultadosObtenemos 2 factores empíricos de MT que no se corresponden con las dimensiones teóricas de maltrato físico, psíquico y sexual, y explican un 64,21% de la varianza; la primera incluye todas las preguntas de abuso psíquico, una del físico y la de abuso sexual; la segunda integra el resto de preguntas de maltrato físico y la de «romper objetos de la casa». Los factores muestran coeficientes de fiabilidad de 0,8688 y 0,7072. La comparación mediante la técnica de grupos extremos muestra que el cuestionario tiene validez de constructo.ConclusiónHemos obtenido un cuestionario fiable y válido para evaluar los malos tratos a mujeres, y su uso, particularmente en atención primaria, puede ser de utilidad para ampliar y profundizar el conocimiento del problema.ObjectivesTo analyse the validity of content and of structure and the reliability of a questionnaire designed to measure illtreatment (IT) of women by their partners.DesignDescriptive, transversal, multi-centre study.SettingFour urban health centres in Granada, Spain.ParticipantsThree hundred and ninety one women of 14 and over who consulted in primary care and had a stable partner for at least 3 months.Main measurementsQuestionnaire by means of interviews between December 2000 and May 2001, with 10 Likert-like questions on physical, psychological, and sexual mistreatment, social and demographic questions and various health indicators.We analysed content validity by means of exploratory factorial analysis, reliability of alpha-Cronbach factors and of corrected scale-item correlation coefficients, and structure validity.ResultsWe obtained 2 empirical IT factors that did not correspond to the theoretical dimensions of physical, psychological, and sexual mistreatment and explained 64.21% of variance. The first included all the questions on psychological abuse, one on physical abuse and the sexual abuse dimension. The second covered the remaining questions on physical IT and “breaking things in the home”. The factors gave reliability coefficients of 0.8688 and 0.7072. Comparison by means of extreme groups technique showed that the questionnaire’s structure is valid.ConclusionWe found this was a reliable and valid questionnaire for evaluating ill-treatment of women. Its use, particularly in primary care, could help expand and deepen understanding of the problem

Three-level methodology for secure and efficient grid integration of electric vehicle

[EN] The secure integration of electric vehicle (EV) plays a key role in the energy transition through a resilient and decarbonised economy. However, a massive EV penetration means a rise in electricity demand with negative consequences to the distribution systems (voltage drops, branches congestion, etc) if the charging infrastructure is not cybersecure and does not perform smart charging mechanisms. Furthermore, these new infrastructures and their operating procedures provide new chances to cyberattacks to be performed, aimed at either exploiting those grid vulnerabilities or acquiring some user's private information. Therefore, to ease the secure integration of EV charging infrastructures in the future network, this paper presents a three-level actuation methodology for charging infrastructures, which includes active management of EV supply equipment (EVSE) to allow dynamic control of charges, installation of ancillary protection systems, planning of EVSE's location within the distribution system and cybersecure management of the whole infrastructure. The presented methodology is based on a thorough analysis of the possible cyberattacks that may occur during the transactions of the charging process, as well as tests carried out on a real pilot, which demonstrate the possible impacts that an uncontrolled charging of the EV can have on the distribution network, thus identifying the vulnerabilities of the distribution network.The preparation of this article has been carried out within the framework of HySGrid+, a Spanish network of Centers of Excellence under the title "Development of energy-positive local communities with hybrid renewable generation and storage systems". HySGrid+ is funded by the Ministry of Science, Innovation and Universities through the CDTI agency, under the Cervera program "CER20191019". The authors of this article also thank the contribution of the "Instituto Valenciano de Competitividad Empresarial (IVACE)" and the European Regional Development Fund (ERDF) for making possible the development of this project, allowing the "Instituto Tecnológico de la Energía (ITE)" to disseminate the results of the research carried out and facilitating and promoting the transfer of knowledge to companies in the Valencian Community.Calatayud-Martí, P.; Romero-Chavarro, JC.; Montagud Aguar, M.; Arcos-Usero, L.; García Pellicer, M.; Quijano-Lopez, A. (2021). Three-level methodology for secure and efficient grid integration of electric vehicle. Dyna: Ingeniería e Industria. 96(3):264-269. https://doi.org/10.6036/1001326426996

Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol.

Background: Currently, the first line treatment of persistent ductus arteriosus (PDA) is either indomethacin or ibuprofen. However, the potentially life-threatening side effects associated to their use have prompted physicians to look for alternative options. The incorporation of paracetamol as an alternative to ibuprofen in the management of PDA is still based on insufficient clinical evidence. Hence, more clinical trials are needed to establish a therapeutic role for paracetamol in the management of PDA that take into consideration short- and long-term safety and efficacy outcomes. Study Design: This is a non-inferiority, randomized, multicenter, double-blinded study to evaluate the efficacy, and safety of intravenous (IV) paracetamol vs. IV ibuprofen (standard treatment) for PDA in preterm patients with a gestational age ≤ 30 weeks. At baseline, patients will be randomized (1:1) to treatment with paracetamol or ibuprofen. The primary endpoint is closure of the ductus after the first treatment course. Secondary endpoints are related to effectiveness (need for a second treatment course, rescue treatment, reopening rate, time to definitive closure, need for surgical ligation), safety (early and long-term complications), pharmacokinetics, and pharmacodynamics, pharmacogenetics, pharmacoeconomics, and genotoxicity. Long-term follow-up to 24 months of corrected postnatal age will be performed using Bayley III neurodevelopmental scale. Trial Registration: ClinicalTrials.gov Identifier: NCT04037514. EudraCT: 2015-003177-14