Massive thymic hemorrhage and hemothorax occurring in utero

Background: Thymic enlargement is a common and physiological finding in children and neonates' X-rays, but it is usually asymptomatic. Occasionally it can cause respiratory distress. In most cases the aetiology of this expansion remains unclear and it is diagnosed as a thymic hyperplasia. True thymic hyperplasia is defined as a gland expansion, both in size and weight, while maintaining normal microscopic architecture. Often it is a diagnosis of exclusion and prognosis is good. Thymic haemorrhage is an unusual condition related to high foetal and neonatal mortality. Case Presentation: We report a case of spontaneous massive thymic haemorrhage in a newborn developing at birth acute respiratory distress associated with severe bilateral haemothorax. Thymic enlargement was evident after pleural evacuation and confirmed by radiographic, Computed Tomography (CT) images and Magnetic Resonance Imaging (MRI) sequences. The spontaneous resolution of this enlargement seen with CT scan and MRI sequences suggested a thymic haemorrhage; surgery was not necessary. Conclusion: Thymic haemorrhage should be considered in newborn infants with pleural effusion, mediastinal space enlargement and Respiratory Distress

Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy

<p>Abstract</p> <p>Background</p> <p>Suboptimal translation of valid and relevant information in clinical practice is a problem for all health systems. Lack of information independent from commercial influences, limited efforts to actively implement evidence-based information and its limited comprehensibility are important determinants of this gap and may influence an excessive variability in physicians' prescriptions. This is quite noticeable in Italy, where the philosophy and methods of Evidence-Based Medicine still enjoy limited diffusion among practitioners. Academic detailing and pharmacist outreach visits are interventions of proven efficacy to make independent and evidence-based information available to physicians; this approach and its feasibility have not yet been tested on a large scale and, moreover, they have never been formally tested in Italy.</p> <p>Methods/Design</p> <p>Two RCTs are planned:</p> <p>1) a two-arm cluster RCT, carried out in Emilia-Romagna and Friuli Venezia Giulia, will evaluate the effectiveness of small group meetings, randomising about 150 Primary Care Groups (corresponding to about 2000 GPs) to pharmacist outreach visits on two different topics. Physicians' prescriptions (expressed as DDD per 1000 inhabitants/day), knowledge and attitudes (evaluated through the answers to a specific questionnaire) will be compared for target drugs in the two groups (receiving/not receiving each topic).</p> <p>2) A three-arm RCT, carried out in Sardinia, will evaluate both the effectiveness of one-to-one meetings (one pharmacist visiting one physician per time) and of a 'new' information format (compared to information already available) on changing physicians' prescription of specific drugs. About 900 single GPs will be randomised into three groups: physicians receiving a visit supported by "traditional" information material, those receiving a visit with "new" information material on the same topic and those not receiving any visit/material.</p> <p>Discussion</p> <p>The two proposed RCTs aim to evaluate the organisational feasibility and barriers to the implementation of independent information programs led by NHS pharmacists. The objective to assess a 10 or 15% decreases in the prescription of the targeted drugs is quite ambitious in such 'natural' settings, which will be minimally altered by the interventions themselves; this in spite of the quite large sample sizes used comparing to other studies of these kind. Complex interventions like these are not easy to evaluate, given the many different variables into play. Anyway, the pragmatic nature of the two RCTs appears to be also one of their major strengths, helping to provide a deeper insight on what is possible to achieve – in terms of independent information – in a National Health System, with special reference to Italy.</p> <p>Trial registration</p> <p>ISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT)</p

How can cry acoustics associate newborns’ distress levels with neurophysiological and behavioral signals?

IntroductionEven though infant crying is a common phenomenon in humans’ early life, it is still a challenge for researchers to properly understand it as a reflection of complex neurophysiological functions. Our study aims to determine the association between neonatal cry acoustics with neurophysiological signals and behavioral features according to different cry distress levels of newborns.MethodsMultimodal data from 25 healthy term newborns were collected simultaneously recording infant cry vocalizations, electroencephalography (EEG), near-infrared spectroscopy (NIRS) and videos of facial expressions and body movements. Statistical analysis was conducted on this dataset to identify correlations among variables during three different infant conditions (i.e., resting, cry, and distress). A Deep Learning (DL) algorithm was used to objectively and automatically evaluate the level of cry distress in infants.ResultsWe found correlations between most of the features extracted from the signals depending on the infant’s arousal state, among them: fundamental frequency (F0), brain activity (delta, theta, and alpha frequency bands), cerebral and body oxygenation, heart rate, facial tension, and body rigidity. Additionally, these associations reinforce that what is occurring at an acoustic level can be characterized by behavioral and neurophysiological patterns. Finally, the DL audio model developed was able to classify the different levels of distress achieving 93% accuracy.ConclusionOur findings strengthen the potential of crying as a biomarker evidencing the physical, emotional and health status of the infant becoming a crucial tool for caregivers and clinicians

Sperimentazione di un nuovo tipo di assistenza pediatrica: l'Osservazione Breve Intensiva (OBI) nell'esperienza di Modena

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Effects of Antioxidant Intake on Fetal Development and Maternal/Neonatal Health during Pregnancy

During pregnancy, cycles of hypoxia and oxidative stress play a key role in the proper development of the fetus. Hypoxia during the first weeks is crucial for placental development, while the increase in oxygen due to the influx of maternal blood stimulates endothelial growth and angiogenesis. However, an imbalance in the number of oxidative molecules due to endogenous or exogenous factors can overwhelm defense systems and lead to excessive production of reactive oxygen species (ROS). Many pregnancy complications, generated by systemic inflammation and placental vasoconstriction, such as preeclampsia (PE), fetal growth restriction (FGR) and preterm birth (PTB), are related to this increase of ROS. Antioxidants may be a promising tool in this population. However, clinical evidence on their use, especially those of natural origin, is scarce and controversial. Following PRISMA methodology, the current review addresses the use of natural antioxidants, such as epigallocatechin gallate (EGCG), melatonin and resveratrol (RESV), as well as other classical antioxidants (vitamin C and E) during the prenatal period as treatment of the above-mentioned complications. We review the effect of antioxidant supplementation on breast milk in lactating mothers

Long Term Effectiveness on Prescribing of Two Multifaceted Educational Interventions: Results of Two Large Scale Randomized Cluster Trials

<div><p>Introduction</p><p>Information on benefits and risks of drugs is a key element affecting doctors’ prescribing decisions. Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours.</p><p>Objectives</p><p>Testing the short and long-term effectiveness on general practitioners’ prescribing of small groups meetings led by pharmacists.</p><p>Methods</p><p>Two cluster open randomised controlled trials (RCTs) were carried out in a large scale NHS setting. Ad hoc prepared evidence based material were used considering a therapeutic area approach - TEA, with information materials on osteoporosis or prostatic hyperplasia - and a single drug oriented approach - SIDRO, with information materials on me-too drugs of 2 different classes: barnidipine or prulifloxacin. In each study, all 115 Primary Care Groups in a Northern Italy area (2.2 million inhabitants, 1737 general practitioners) were randomised to educational small groups meetings, in which available evidence was provided together with drug utilization data and clinical scenarios. Main outcomes were changes in the six-months prescription of targeted drugs. Longer term results (24 and 48 months) were also evaluated.</p><p>Results</p><p>In the TEA trial, one of the four primary outcomes showed a reduction (prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia: prescribing ratio −8.5%, p = 0.03). Another primary outcome (prescription of risedronate) showed a reduction at 24 and 48 months (−7.6%, p = 0.02; and −9,8%, p = 0.03), but not at six months (−5.1%, p = 0.36). In the SIDRO trial both primary outcomes showed a statistically significant reduction (prescription of barnidipine −9.8%, p = 0.02; prescription of prulifloxacin −11.1%, p = 0.04), which persisted or increased over time.</p><p>Interpretation</p><p>These two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting, and its potentially relevant long-term impact on prescribing habits, in particular when focusing on a single drug. National Health systems should invest in independent drug information programs.</p><p>Trial Registration</p><p>Controlled-Trials.com <a href="http://www.controlled-trials.com/ISRCTN05866587" target="_blank">ISRCTN05866587</a></p></div

Data_Sheet_1_How can cry acoustics associate newborns’ distress levels with neurophysiological and behavioral signals?.PDF

IntroductionEven though infant crying is a common phenomenon in humans’ early life, it is still a challenge for researchers to properly understand it as a reflection of complex neurophysiological functions. Our study aims to determine the association between neonatal cry acoustics with neurophysiological signals and behavioral features according to different cry distress levels of newborns.MethodsMultimodal data from 25 healthy term newborns were collected simultaneously recording infant cry vocalizations, electroencephalography (EEG), near-infrared spectroscopy (NIRS) and videos of facial expressions and body movements. Statistical analysis was conducted on this dataset to identify correlations among variables during three different infant conditions (i.e., resting, cry, and distress). A Deep Learning (DL) algorithm was used to objectively and automatically evaluate the level of cry distress in infants.ResultsWe found correlations between most of the features extracted from the signals depending on the infant’s arousal state, among them: fundamental frequency (F0), brain activity (delta, theta, and alpha frequency bands), cerebral and body oxygenation, heart rate, facial tension, and body rigidity. Additionally, these associations reinforce that what is occurring at an acoustic level can be characterized by behavioral and neurophysiological patterns. Finally, the DL audio model developed was able to classify the different levels of distress achieving 93% accuracy.ConclusionOur findings strengthen the potential of crying as a biomarker evidencing the physical, emotional and health status of the infant becoming a crucial tool for caregivers and clinicians.</p

% differences in primary outcomes at 6 months (main analysis), 12, 24 and 48 months.

<p>% differences in primary outcomes at 6 months (main analysis), 12, 24 and 48 months.</p