NEO-SAFE: a clinical model for patients and healthcare personnel safety in primary level hospitals.

Patient safety is a major concern in medicine. Approximately, 4 million infants die each year worldwide and 23% of these deaths are caused by perinatal asphyxia. To prevent the long-term damage of asphyxia, the resuscitation flowchart must be perfectly and promptly performed. However, high effectiveness in performing resuscitation can only be achieved and maintained if the algorithm is frequently executed. Therefore, maintaining a high level of patient care is difficult in some remote centres. The aim of this study was to evaluate the effectiveness of a new organizational model of care-network between Hub & Spoke hospitals to improve both the safety of the newborns in hospitals with a low number of births and the well-being of operators. Our project, NEO-SAFE (NEOnatal SAFety and training Elba), began in 2017 and involved the neonatal intensive care unit and the NINA Center of the Pisa University Hospital (hub) and the Hospital of Elba Island (spoke). It consisted of a continuous training program, both with 'classic' training course and 'on-job tutoring' (on side and remotely), of the health workers at spoke (i.e. nurses, midwives, and paediatricians). All four milestones of the study design were achieved. During the project, NINA Center instructors organized training courses for the staff in Portoferraio. These courses were based on learning technical and non-technical skills in a training course of increasing difficulty. Staff training needs were also monitored during the project by means of periodic questionnaires, sentinel events, and specific requests. The curve described by the rate of newborns transfer to the Pisa neonatal intensive care unit (hub) shows a monotonous decreasing trend line. On the other hand, this project allowed operators to develop greater self-confidence and greater safety in managing emergency situations, reducing stress for them and improving patient safety. The project allowed the creation of a safe, effective, low-cost, and reproducible organizational model for centres with a low number of births. Moreover, the tele-medicine approach is an important improvement in the assistance and is a window on the future.

A New Web Score to Predict Health Status in Paediatric Patients with Chronic Diseases: Design and Development of the PENSAMI Study.

Paediatric chronic diseases (CD) are characterised by their ongoing duration and the fact that they are often managed throughout the lifespan, with the need to adjust lifestyle and expectations with the limitations coming from the CD. The aim of the PENSAMI study is to not only cure the disease, but to also care for the person from a clinical and psychosocial perspective. Data will be collected from 150 paediatric patients affected by heart disease, diabetes, and asthma admitted during in-hospital stay or outpatient visits, and from 200 healthy control subjects. The protocol will consist of two phases. The first one will aim at elaborating the predictive model by detecting (clinical, anthropometric at birth, environmental, lifestyle, social context, emotional state, and mental abilities) in order to develop a model predictive of the events considered: (1) re-hospitalisation; (2) severity and progression of the disease; (3) adherence to therapy; (4) HRQoL; (5) obesity and metabolic syndrome; (6) illness-stress related; (7) school drop-out; (8) school performance. The second one will address validating the previous predictive model. This model will aim to: (1) understand, prevent, and halt the progression of childhood CD; (2) develop new and improved diagnostic tools; (3) pave the way for innovative treatments and additional therapies to traditional clinical practice; and (4) create truly personalised therapeutic and preventive strategies in various sectors, such as cardiology, diabetes, and respiratory diseases.

Counterfeit homeopathic medicinal products: syrups. A simple and rapid LC-ESI-MS method to detect preservatives not declared in label.

A rapid and simple LC-ESI-MS method for the simultaneous detection and quantitation of six preservatives in homeopathic syrups has been developed. Counterfeit homeopathic syrups are suspected to contain preservatives that are not declared in label. For this reason a method to ascertain the absence of sorbic and benzoic acids, methyl-, ethyl-, propyl- and butyl-parabens, as the most frequently utilised preservatives, has been developed. Analytes were eluted with a linear gradient of acetonitrile-5mM ammonium acetate in 12 min using 2,4-dichlorobenzylalchol as Internal Standard. The HPLC separation was performed on an Eclipse XDB-C18 (2.1 mm x 50 mm-5 microm) column and the ESI-MS detection was performed in negative ion mode. Linearity of the method was studied in the range of 2 pg to 10 ng injected and correlation coefficients r2 > or =0.9992 were obtained. LOD ranged from 0.04 to 0.4 ng mL(-1).

S100B Protein concentration in milk-formulas for preterm and term infants. Correlation with industrial preparation procedures.

Human milk S100B protein possesses important neurotrophic properties. However, in some conditions human milk is substituted by milk formulas. The aims of the present study were: to assess S100B concentrations in milk formulas, to verify any differences in S100B levels between preterm and term infant formulas and to evaluate the impact of industrial preparation at predetermined phases on S100B content. Two different set of samples were tested: (i) commercial preterm (n = 36) and term (n = 36) infant milk formulas; ii) milk preterm (n = 10) and term infant (n = 10) formulas sampled at the following predetermined industrial preparation time points: skimmed cow milk (Time 0); after protein sources supplementation (Time 1); after pasteurization (Time 2); after spray-drying (Time 3). Our results showed that S100B concentration in preterm formulas were higher than in term ones (p < 0.01). In addition, S100B concentrations during industrial preparation showed a significant increase (p < 0.001) at Time 1 followed by a slight decrease (p > 0.05) at Time 2, whereas a significant (p < 0.001) dip was observed at Time 3. In conclusion, S100B showed a sufficient thermostability to resist pasteurization but not spry-drying. New feeding strategies in preterm and term infants are therefore warranted in order to preserve S100B protein during industrial preparation.

High-performance liquid chromatography analysis of anti-inflammatory pharmaceuticals with ultraviolet and electrospray-mass spectrometry detection in suspected counterfeit homeopathic medicinal products.

A simple high-performance liquid chromatography (HPLC) method with both ultraviolet (UV) and electrospray ionisation mass spectrometry (ESI-MS) detection has been developed for the determination of seven pharmaceuticals in counterfeit homeopathic preparations. Naproxen, Ketoprofen, Ibuprofen, Diclofenac, Piroxicam, Nimesulide and Paracetamol were separated by reversed phase chromatography with acetonitrile-water (0.1% acetic acid) mobile phase, and detected by UV at 245 nm and by ESI-MS in negative ionisation mode with the exception of Paracetamol which was detected in positive ionisation mode. Benzoic acid was used as internal standard (IS). This method was successfully applied to the analysis of homeopathic preparations like mother tinctures, solutions, tablets, granules, creams, and suppositories. Linearity was studied with UV detection in the 50-400 microg mL(-1) range and with ESI-MS in the 0.1-50 microg mL(-1) range. Good correlation coefficients were found in both UV and ESI-MS. Detection limits ranged from 0.18 to 41.5 ng in UV and from 0.035 to 1.00 ng in ESI-MS.