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.

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.

Feeding Practices in Very Preterm and Very Low Birth Weight Infants in an Area Where a Network of Human Milk Banks Is in Place.

Background: Great variability in enteral feeding practices for very preterm (<32 weeks gestational age-GA) and very low birth weight infants (VLBW; ≤1,500 g) have been reported. We aimed to describe data on enteral feeding in Tuscany (Italy), where a network of 6 donor milk banks is in place. Methods: A 4-years (2012-2015) observational study was performed analyzing the database "TIN Toscane online" on very preterm and VLBW infants. The database covers all 25 hospitals with a neonatal unit. Results: Data concerning the beginning of enteral nutrition were available for 1,302 newborns with a mean (standard deviation) GA of 29.3 (2.9) weeks, while information at the time of full enteral nutrition was available for 1,235 and at discharge for 1,140. Most infants (74.1%) started enteral feeding during the first 24 h of life. Overall, 80.1% of newborns were fed exclusive human milk, donor milk having the larger prevalence of use (66.8%). Few infants (13.3%) started with exclusive mother's milk. Full enteral feeding was achieved using exclusive human milk in most cases (80%). Full enteral feeding was reached earlier in newborns who were fed human milk than in those fed formula, regardless of GA. Sixty-four percent of infants were still fed with any human milk at discharge. When data at the achievement of full enteral nutrition and at discharge were analyzed stratified by the type of milk used to start enteral feeding, newborns initially fed donor milk presented the highest prevalence (91.3%) of exclusive human milk at full enteral feeding, an important period to prevent necrotizing enterocolitis, while no differences were observed at discharge. Conclusions: Donor milk was widely used for newborns during the first hours of life, when mother's milk availability may be quite challenging. Starting enteral nutrition with donor milk was associated with early start of enteral feeding and early achievement of full enteral nutrition without affecting mother lactation. The overall prevalence of human milk at discharge (when donor milk is not available anymore) was high (64%), irrespective of the type of milk used to start nutrition.

Variations in Oxygen Saturation Targeting, and Retinopathy of Prematurity Screening and Treatment Criteria in Neonatal Intensive Care Units: An International Survey.

BACKGROUND: Rates of retinopathy of prematurity (ROP) and ROP treatment vary between neonatal intensive care units (NICUs). Neonatal care practices, including oxygen saturation (SpO2) targets and criteria for the screening and treatment of ROP, are potential contributing factors to the variations. OBJECTIVES: To survey variations in SpO2 targets in 2015 (and whether there had been recent changes) and criteria for ROP screening and treatment across the networks of the International Network for Evaluating Outcomes in Neonates (iNeo). METHODS: Online prepiloted questionnaires on treatment practices for preterm infants were sent to the directors of 390 NICUs in 10 collaborating iNeo networks. Nine questions were asked and the results were summarized and compared. RESULTS: Overall, 329/390 (84%) NICUs responded, and a majority (60%) recently made changes in upper and lower SpO2 target limits, with the median set higher than previously by 2-3% in 8 of 10 networks. After the changes, fewer NICUs (15 vs. 28%) set an upper SpO2 target limit > 95% and fewer (3 vs. 5%) a lower limit < 85%. There were variations in ROP screening criteria, and only in the Swedish network did all NICUs follow a single guideline. The initial retinal examination was carried out by an ophthalmologist in all but 6 NICUs, and retinal photography was used in 20% but most commonly as an adjunct to indirect ophthalmoscopy. CONCLUSIONS: There is considerable variation in SpO2 targets and ROP screening and treatment criteria, both within networks and between countries.

Area-based study identifies risk factors associated with missed antenatal corticosteroid prophylaxis in women delivering preterm infants.

AIM: All women delivering a preterm infant should receive antenatal corticosteroid prophylaxis, but many miss this opportunity. We determined the risk factors associated with missed prophylaxis in a geographically defined area of Italy. METHODS: We prospectively studied all mothers who delivered babies between 24 and 31 completed weeks of gestation, from 2009 to 2013, in all maternity units in Tuscany. RESULTS: Of 1232 mothers, 186 (15.1%) did not receive prophylaxis. The risk was higher in migrant mothers, with an adjusted risk ratio (RR) of 1.28 and 95% confidence interval (95% CI) of 1.04-1.56, and in mothers hospitalised for less than 24 hours (RR 4.09, 95% CI: 2.90-5.78). Preterm prelabour rupture of membranes (RR 0.63, 95% CI: 0.41-0.96) and maternal antepartum transfer (RR 0.24, 95% CI: 0.18-0.32) were protective. Hospital level at birth and gestational age did not influence the prophylaxis rate. The population-attributable fractions were 50.4% for late hospital admissions and 10.2% for migrant status. CONCLUSION: In a highly organised network of hospitals, neither level of care nor gestational age influenced prophylaxis. Timely arrival of women in hospital, better recognition of the imminence of delivery and tighter steroids administration guidelines are the most relevant targets to further increase prophylaxis.

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.

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.

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.