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.

Improving Pediatric/Neonatology Residents' Newborn Resuscitation Skills With a Digital Serious Game: DIANA.

Background: Serious games, and especially digital game based learning (DGBL) methodologies, have the potential to strengthen classic learning methodology in all medical procedures characterized by a flowchart (e.g., neonatal resuscitation algorithm). However, few studies have compared short- and long-term knowledge retention in DGBL methodologies with a control group undergoing specialist training led by experienced operators. In particular, resident doctors' learning still has limited representation in simulation-based education literature. Objective: A serious computer game DIANA (DIgital Application in Newborn Assessment) was developed, according to newborn resuscitation algorithm, to train pediatric/neonatology residents in neonatal resuscitation algorithm knowledge and implementation (from procedure knowledge to ventilation/chest compressions rate). We analyzed user learning curves after each session and compared knowledge retention against a classic theoretical teaching session. Methods: Pediatric/neonatology residents of the Azienda Ospedaliera Universitaria Pisana (AOUP) were invited to take part in the study and were split into a game group or a control group; both groups were homogeneous in terms of previous training and baseline scores. The control group attended a classic 80 min teaching session with a neonatal trainer, while game group participants played four 20 min sessions over four different days. Three written tests (pre/immediately post-training and at 28 days) were used to evaluate and compare the two groups' performances. Results: Forty-eight pediatric/neonatology residents participated in the study. While classic training by a neonatal trainer demonstrated an excellent effectiveness in short/long-term knowledge retention, DGBL methodology proved to be equivalent or better. Furthermore, after each game session, DGBL score improved for both procedure knowledge and ventilation/chest compressions rate. Conclusions: In this study, DGBL was as effective as classic specialist training for neonatal resuscitation in terms of both algorithm memorization and knowledge retention. User appreciation for the methodology and ease of administration, including remotely, support the use of DGBL methodologies for pediatric/neonatology residents education.

Maternal anthropometric variables and clinical factors shape neonatal microbiome.

Recent studies indicate the existence of a complex microbiome in the meconium of newborns that plays a key role in regulating many host health-related conditions. However, a high variability between studies has been observed so far. In the present study, the meconium microbiome composition and the predicted microbial metabolic pathways were analysed in a consecutive cohort of 96 full-term newborns. The effect of maternal epidemiological variables on meconium diversity was analysed using regression analysis and PERMANOVA. Meconium microbiome composition mainly included Proteobacteria (30.95%), Bacteroidetes (23.17%) and Firmicutes (17.13%), while for predicted metabolic pathways, the most abundant genes belonged to the class "metabolism". We observed a significant effect of maternal Rh factor on Shannon and Inverse Simpson indexes (p = 0.045 and p = 0.049 respectively) and a significant effect of delivery mode and maternal antibiotic exposure on Jaccard and Bray-Curtis dissimilarities (p = 0.001 and 0.002 respectively), while gestational age was associated with observed richness and Shannon indexes (p = 0.018 and 0.037 respectively), and Jaccard and Bray-Curtis dissimilarities (p = 0.014 and 0.013 respectively). The association involving maternal Rh phenotype suggests a role for host genetics in shaping meconium microbiome prior to the exposition to the most well-known environmental variables, which will influence microbiome maturation in the newborn.

Early-onset sepsis risk calculator: a review of its effectiveness and comparative study with our evidence-based local guidelines.

BACKGROUND: According to most early-onset sepsis (EOS) management guidelines, approximately 10% of the total neonatal population are exposed to antibiotics in the first postnatal days with subsequent increase of neonatal and pediatric comorbidities. A review of literature demonstrates the effectiveness of EOS calculator in reducing antibiotic overtreatment and NICU admission among neonates ≥34 weeks' gestational age (GA); however, some missed cases of culture-positive EOS have also been described. METHODS: Single-center retrospective study from 1st January 2018 to 31st December 2018 conducted in the Division of Neonatology at Santa Chiara Hospital (Pisa, Italy). Neonates ≥34 weeks' GA with birth weight ≤ 1500 g, 34-36 weeks' GA neonates with suspected intraamniotic infection and neonates ≥34 weeks' GA with three clinical signs of EOS or two signs and one risk factor for EOS receive empirical antibiotics. Neonates ≥34 weeks' GA with risk factors for EOS or with one clinical indicator of EOS undergo serial measurements of C-reactive protein and procalcitonin in the first 48-72 h of life; they receive empirical antibiotics in case of abnormalities at blood exams with one or more clinical signs of EOS. Two hundred sixty-five patients at risk for EOS met inclusion criteria; they were divided into 3 study groups: 34-36 weeks' GA newborns (n = 95, group A), ≥ 37 weeks' GA newborns (n = 170, group B), and ≥ 34 weeks' GA newborns (n = 265, group A + B). For each group, we compared the number of patients for which antibiotics would have been needed, based on EOS calculator, and the number of the same patients we treated with antibiotics during the study period. Comparisons between the groups were performed using McNemar's test and statistical significance was set at p < 0.05; post-hoc power analysis was carried out to evaluate the sample sizes. RESULTS: 32/265 (12.1%) neonates ≥34 weeks' GA received antibiotics within the first 12 h of life. According to EOS calculator 55/265 (20.7%) patients would have received antibiotics with EOS incidence 2/1000 live births (p < 0.0001). CONCLUSION: Our evidence-based protocol entails a further decrease of antibiotic overtreatment compared to EOS calculator. No negative consequences for patients were observed.

Polymorphic variants in Sweet and Umami taste receptor genes and birthweight.

The first thousand days of life from conception have a significant impact on the health status with short, and long-term effects. Among several anthropometric and maternal lifestyle parameters birth weight plays a crucial role on the growth and neurological development of infants. Recent genome wide association studies (GWAS) have demonstrated a robust foetal and maternal genetic background of birth weight, however only a small proportion of the genetic hereditability has been already identified. Considering the extensive number of phenotypes on which they are involved, we focused on identifying the possible effect of genetic variants belonging to taste receptor genes and birthweight. In the human genome there are two taste receptors family the bitter receptors (TAS2Rs) and the sweet and umami receptors (TAS1Rs). In particular sweet perception is due to a heterodimeric receptor encoded by the TAS1R2 and the TAS1R3 gene, while the umami taste receptor is encoded by the TAS1R1 and the TAS1R3 genes. We observed that carriers of the T allele of the TAS1R1-rs4908932 SNPs showed an increase in birthweight compared to GG homozygotes Coeff: 87.40 (35.13-139.68) p-value = 0.001. The association remained significant after correction for multiple testing. TAS1R1-rs4908932 is a potentially functional SNP and is in linkage disequilibrium with another polymorphism that has been associated with BMI in adults showing the importance of this variant from the early stages of conception through all the adult life.

Enhancing the future of simulation-based education in pediatrics.

Technology-enhanced simulation has emerged as a great educational tool for pediatric education. Indeed, it represents an effective method to instruct on technical and non-technical skills, employed by a large number of pediatric training programs. However, this unique pandemic era posed new challenges also on simulation-based education. Beyond the mere facing of the clinical and societal impacts, it is fundamental to take advantage from the current changes and investigate innovative approaches to improve the education of pediatric healthcare professionals. To this aim, we herein lay down the main pillars that should support the infrastructure of the future technology-enhanced simulation.

Effectiveness of a new sensorized videolaryngoscope for retraining on neonatal intubation in simulation environment.

BACKGROUND: In recent years, medical training has significantly increased the use of simulation for teaching and evaluation. The retraining of medical personnel in Italy is entrusted to the program of Continuous Education in Medicine, mainly based on theoretical training. The aim of this study is to assess whether the use of a new sensorized platform for the execution of the neonatal intubation procedure in simulation environment can complement theoretical retraining of experienced health professionals. METHODS: Neonatal intubation tests were performed using a commercial manikin and a modified video-laryngoscope by the addition of force and position sensors, which provide the user with feedback when the threshold is exceeded. Two categories carried out the simulation tests: anesthesiologists and pediatricians. The categories were divided into three groups each, and various configurations were tested: the first group of both specialists carried out the tests without feedback (i.e. control groups, gr. A and A1), the second groups received sound and visual feedback from the instrument (gr. B and B1) and the third ones had also the support of a physician expert in the use of the instrument (gr. C and C1). The instrumentation used by pediatricians was provided in a playful form, including a game with increasing difficulty levels. RESULTS: Both in the case with feedback only and in the case with humans support, anesthesiologists did not show a specific trend of improvement. Pediatricians, in comparison with anesthesiologists, showed a positive reaction to both the presence of feedback and that of experienced personnel. Comparing the performance of the two control groups, the two categories of experienced doctors perform similar forces. Pediatricians enjoyed the "Level Game", through which they were able to test and confront themselves, trying to improve their own performance. CONCLUSIONS: Our instrument is more effective when is playful and competitive, introducing something more than just a sound feedback, and allowing training by increasing levels. It is more effective if the users can adapt their own technique to the instrument by themselves, without any external help.

Micro-extraction by packed sorbent combined with UHPLC-ESI-MS/MS for the determination of prostanoids and isoprostanoids in dried blood spots.

This work presents a reliable analytical procedure combining micro-extraction by packed sorbent (MEPS) and ultra-high performance liquid chromatography-electrospray ionization tandem mass spectrometry to determine 8-iso prostaglandin F2α, 8-iso prostaglandin E2 and prostaglandin E2 in dried blood spots (DBSs). To reach this goal, we optimized a fast semi-automated MEPS procedure for the clean-up and pre-concentration of the analytes extracted from a single DBS (50 µL) by a 70:30 v/v methanol:water mixture. Limits of detection of about 20 pg mL-1, satisfactory recoveries (90-110%) and very good intra- and inter-day precisions (RSD ≤10%) were obtained for all the analytes. The innovative addition of internal standards on the filter paper before DBS sampling allowed to compensate changes in the amount of analyte during storage. Since prostanoids and isoprostanoids are biomarkers involved in the pathogenesis and progression of many diseases (e.g. ductal patency, diabetic nephropathy, and acute lung injury), our analytical method offers interesting diagnostic and prognostic opportunities in the medical field. The present method is currently used for the analysis of such biomarkers in DBSs from preterm newborns collected in the clinical setting.

Technical realization of a sensorized neonatal intubation skill trainer for operators' retraining and a pilot study for its validation.

BACKGROUND: In neonatal endotracheal intubation, excessive pressure on soft tissues during laryngoscopy can determine permanent injury. Low-fidelity skill trainers do not give valid feedback about this issue. This study describes the technical realization and validation of an active neonatal intubation skill trainer providing objective feedback. METHODS: We studied expert health professionals' performances in neonatal intubation, underlining chance for procedure retraining. We identified the most critical points in epiglottis and dental arches and fixed commercial force sensors on chosen points on a ©Laerdal Neonatal Intubation Trainer. Our skill trainer was set up as a grade 3 on Cormack and Lehane's scale, i.e. a model of difficult intubation. An associated software provided real time sound feedback if pressure during laryngoscopy exceeded an established threshold. Pressure data were recorded in a database, for subsequent analysis with non-parametric statistical tests. We organized our study in two intubation sessions (5 attempts each one) for everyone of our participants, held 24 h apart. Between the two sessions, a debriefing phase took place. In addition, we gave our participants two interview, one at the beginning and one at the end of the study, to get information about our subjects and to have feedback about our design. RESULTS: We obtained statistical significant differences between consecutive attempts, with evidence of learning trends. Pressure on critical points was significantly lower during the second session (p < 0.0001). Epiglottis' sensor was the most stressed (p < 0.000001). We found a significant correlation between time spent for each attempt and pressures applied to the airways in the two sessions, more significant in the second one (shorter attempts with less pressure, rs = 0.603). CONCLUSIONS: Our skill trainer represents a reliable model of difficult intubation. Our results show its potential to optimize procedures related to the control of trauma risk and to improve personnel retraining.

Simulation of childbirth improves clinical management capacity and self-confidence in medical students.

Background The learning process of physiological mechanisms of childbirth and its management are important elements in the education of medical students. In this study, we verify how the use of a high-fidelity simulator of childbirth improves competence of students in this regard. Methods A total of 132 medical students were recruited for the study in order to attend a physiological childbirth in a no-hospital environment after being assigned to two groups. The control group received only a normal cycle of lectures, while the simulation (SIM) group followed a specific training session on the simulator. Subsequently, both groups were assessed for their technical and non-technical skills in a simulated childbirth. Also, a self-assessment test regarding their self-confidence was administrated before and after simulation, and repeated after 8 weeks. Results The SIM group showed better performance in all the domains with a better comprehension of the mechanisms of childbirth, managing and assistance of labour and delivery. In addition, compared to the control group, they presented a better self-related awareness and self-assurance regarding the possibility of facing a birth by themselves. Conclusion The present study demonstrated that the use of a high-fidelity simulator for medical students allows a significant improvement in the acquisition of theoretical and technical expertise to assist a physiological birth.

Catheter and Laryngeal Mask Endotracheal Surfactant Therapy: the CALMEST approach as a novel MIST technique.

PURPOSE: Neonatal respiratory distress syndrome (RDS) is a major cause of mortality and morbidity among preterm infants. Although the INSURE (INtubation, SURfactant administration, Estubation) technique for surfactant replacement therapy is so far the gold standard method, over the last years new approaches have been studied, i.e. less invasive surfactant administration (LISA) or minimally invasive surfactant therapy (MIST). Here we propose an originally modified MIST, called CALMEST (Catheter And Laryngeal Mask Endotracheal Surfactant Therapy), using a particular laryngeal mask as a guide for a thin catheter to deliver surfactant directly in the trachea. MATERIALS AND METHODS: We performed a preliminary study on a mannequin and a subsequent in vivo pilot trial. RESULTS AND CONCLUSIONS: This novel procedure is quick, effective and well tolerated and might represent an improvement in reducing neonatal stress. Ultimately, CALMEST offers an alternative approach that could be extremely useful for medical staff with low expertise in laryngoscopy and intubation.

An active simulator for neonatal intubation: Design, development and assessment.

This study describes the technical realization and the pre-clinical validation of a instrumented neonatal intubation skill trainer able to provide objective feedback for the improvement of clinical competences required for such a delicate procedure. The Laerdal® Neonatal Intubation Trainer was modified by applying pressure sensors on areas that are mainly subject to stress and potential injuries. Punctual Force Sensing Resistors (FSRs) were characterized and fixed on the external side of the airway structure on the dental arches and epiglottis. A custom silicone tongue was designed and developed to integrate a matrix textile sensor for mapping the pressure applied on its whole surface. The assessment of the developed tool was performed by nine clinical experts who were asked to practice three intubation procedures apiece. Median and maximum forces, over threshold events (i.e. 2N for gingival arch sensors and 7N for epiglottis and tongue sensors respectively) and execution time were measured for each trainee. Data analysis from training sessions revealed that the epiglottis is the point mainly stressed during an intubation procedure (maximum value: 16.69N, median value: 3.11N), while the analysis carried out on the pressure distribution on the instrumented tongue provided information on both force values and distribution, according to clinicians' performance. The debriefing phase was used to enhance the clinicians' awareness of applied force and gestures performed, confirming that the present study is an adequate starting point for achieving and optimizing neonatal intubation skills for both residents and expert clinicians.

Effect of high-fidelity shoulder dystocia simulation on emergency obstetric skills and crew resource management skills among residents.

OBJECTIVE: To determine the effect of a simulation training program for residents in obstetrics and gynecology in terms of technical and nontechnical skills for the management of shoulder dystocia. METHODS: A prospective study was performed at a center in Italy in April-May 2015. Thirty-two obstetrics and gynecology residents were divided into two groups. Residents in the control group were immediately exposed to an emergency shoulder dystocia scenario, whereas those in the simulation group completed a 2-hour training session with the simulator before being exposed to the scenario. After 8weeks, the residents were again exposed to the shoulder dystocia scenario and reassessed. Participants were scored on their demonstration of technical and nontechnical skills. RESULTS: In the first set of scenarios, the mean score was higher in the simulation group than the control group in terms of both technical skills (P=0.008) and nontechnical skills (P<0.001). This difference was retained after 8weeks. CONCLUSION: High-fidelity simulation programs could be used for the training of residents in obstetrics and gynecology to diagnose and manage obstetric emergencies such as shoulder dystocia.

A novel simulator for mechanical ventilation in newborns: MEchatronic REspiratory System SImulator for Neonatal Applications.

Respiratory problems are among the main causes of mortality for preterm newborns with pulmonary diseases; mechanical ventilation provides standard care, but long-term complications are still largely reported. In this framework, continuous medical education is mandatory to correctly manage assistance devices. However, commercially available neonatal respiratory simulators are rarely suitable for representing anatomical and physiological conditions; a step toward high-fidelity simulation, therefore, is essential for nurses and neonatologists to acquire the practice needed without any risk. An innovative multi-compartmental infant respirator simulator based on a five-lobe model was developed to reproduce different physio-pathological conditions in infants and to simulate many different kinds of clinical scenarios. The work consisted of three phases: (1) a theoretical study and modeling phase, (2) a prototyping phase, and (3) testing of the simulation software during training courses. The neonatal pulmonary simulator produced allows the replication and evaluation of different mechanical ventilation modalities in infants suffering from many different kinds of respiratory physio-pathological conditions. In particular, the system provides variable compliances for each lobe in an independent manner and different resistance levels for the airway branches; moreover, it allows the trainer to simulate both autonomous and mechanically assisted respiratory cycles in newborns. The developed and tested simulator is a significant contribution to the field of medical simulation in neonatology, as it makes it possible to choose the best ventilation strategy and to perform fully aware management of ventilation parameters.

Comparative performances analysis of neonatal ventilators.

BACKGROUND: Mechanical ventilation is a therapeutic action for newborns with respiratory diseases but may have side effects. Correct equipment knowledge and training may limit human errors. We aimed to test different neonatal mechanical ventilators' performances by an acquisition module (a commercial pressure sensor plus an isolated chamber and a dedicated software). METHODS: The differences (ΔP) between peak pressure values and end-expiration pressure were investigated for each ventilator. We focused on discrepancies among measured and imposed pressure data. A statistical analysis was performed. RESULTS: We investigated the measured/imposed ΔP relation. The ΔP do not reveal univocal trends related to ventilation setting parameters and the data distributions were non-Gaussian. CONCLUSIONS: Measured ΔP represent a significant parameter in newborns' ventilation, due to the typical small volumes. The investigated ventilators showed different tendencies. Therefore, a deep specific knowledge of the intensive care devices is mandatory for caregivers to correctly exploit their operating principles.

An active one-lobe pulmonary simulator with compliance control for medical training in neonatal mechanical ventilation.

Mechanical ventilation is a current support therapy for newborns affected by respiratory diseases. However, several side effects have been observed after treatment, making it mandatory for physicians to determine more suitable approaches. High fidelity simulation is an efficient educational technique that recreates clinical experience. The aim of the present study is the design of an innovative and versatile neonatal respiratory simulator which could be useful in training courses for physicians and nurses as for mechanical ventilation. A single chamber prototype, reproducing a pulmonary lobe both in size and function, was designed and assembled. Volume and pressure within the chamber can be tuned by the operator through the device control system, in order to simulate both spontaneous and assisted breathing. An innovative software-based simulator for training neonatologists and nurses within the continuing medical education program on respiratory disease management was validated. Following the clinical needs, three friendly graphic user interfaces were implemented for simulating three different clinical scenarios (spontaneous breathing, controlled breathing and triggered/assisted ventilation modalities) thus providing physicians with an active experience. The proposed pulmonary simulator has the potential to be included in the range of computer-driven technologies used in medical training, adding novel functions and improving simulation results.

Preterm birth, respiratory failure and BPD: which neonatal management?

Preterm birth is a significant problem in the world regarding perinatal mortality and morbidity in the long term, especially bronchopulmonary dysplasia (BPD). Premature delivery is often associated to failure in transition to create an early functional residual capacity (FRC), since many preterm babies need frequently respiratory support. The first and most effective preventive measure to reduce the incidence of BPD is represented by the attempt to avoid preterm birth. Whenever this fails, the prevention of every known risk factors for BPD should start in the delivery room and should be maintained in the NICU through the use of tailored management of high-risk infants.

MEchatronic REspiratory System SImulator for Neonatal Applications (MERESSINA) project: a novel bioengineering goal.

Respiratory function is mandatory for extrauterine life, but is sometimes impaired in newborns due to prematurity, congenital malformations, or acquired pathologies. Mechanical ventilation is standard care, but long-term complications, such as bronchopulmonary dysplasia, are still largely reported. Therefore, continuous medical education is mandatory to correctly manage devices for assistance. Commercially available breathing function simulators are rarely suitable for the anatomical and physiological realities. The aim of this study is to develop a high-fidelity mechatronic simulator of neonatal airways and lungs for staff training and mechanical ventilator testing. The project is divided into three different phases: (1) a review study on respiratory physiology and pathophysiology and on already available single and multi-compartment models; (2) the prototyping phase; and (3) the on-field system validation.

Education in neonatology by simulation: between reality and declaration of intent.

An unexpected event is not rare in Neonatology and can be dramatic: the operators must act with the right skills and abilities in the shortest time. Often it is a team effort and each member must be trained adequately. According to the "Swiss cheese" model by J. Reason, an accident is never the consequence of a single error, but the very final result of a chain of misunderstandings, irregularities or negligence (cheese holes): several holes allow the final medical error. Therefore, we should avoid those holes in our work. The clinical risk is always around the corner. The legal issues are becoming more and more relevant and lead to a defensive medicine, which is definitely not the best practice. For this reason, raising the safety standards is mandatory. With this purpose, after a decade of experience in "traditional" training courses, we started testing a new strategy of continuous education in Neonatology by means of highfidelity simulation. Since 2008, we have arranged and managed a Center for Neonatal Simulation and Advanced Training in the Neonatology Unit of the University Hospital of Pisa. We have already delivered courses to pediatricians, neonatologists, anesthesiologists, gynecologists, emergency doctors, midwives and nurses, using an advanced Laerdal SimNewB simulator to teach diagnostic and therapeutic skills or communication strategies. The model has been proposed to the Italian Society of Neonatology and it has been decided to create a Task Force to discuss our model and encourage to use it in other Italian areas.

Correlation between placental histopathology and fetal/neonatal outcome: chorioamnionitis and funisitis are associated to intraventricular haemorrage and retinopathy of prematurity in preterm newborns.

INTRODUCTION: Placental anatomopathologic lesions are usually associated with pregnancy complications and neonatal impaired outcome. PATIENTS AND METHODS: We included in our study 122 patients with gestational age of 26-35 weeks. From the analysis of three pathological aspects (chorioamnionitis, funisitis and chronic hypoxia), a score was assigned to each lesion depending on the severity of the alteration, to establish a correlation with an impaired neonatal outcome in preterm newborns. RESULTS: We found a correlation between chronic hypoxia and preeclampsia, intrauterine growth restriction and/or small-for-gestational age status at birth. Our results also showed the strong association of fetal placental inflammatory status (chorioamnionitis and funisitis) with premature rupture of membranes, very low birth weight, birth at/before 32 gestational weeks, late-onset sepsis, patent duct arteriosus, intraventricular haemorrhage (IVH) and retinopathy of prematurity (ROP). CONCLUSIONS: We confirm that placental lesions are associated with impaired pregnancy and neonatal outcome. During pregnancy it may be useful to identify some markers of inflammatory status and chronic hypoxia for an early diagnosis and a detailed monitoring of pregnancy course. Placental pathological analysis is very important to predict the risk of developing serious complications of preterm birth as ROP and IVH.