Use of Telemedicine Healthcare Systems in Pediatric Assistance at Territorial Level: Consensus Document of the Italian Society of Telemedicine (SIT), of the Italian Society of Preventive and Social Pediatrics (SIPPS), of the Italian Society of Pediatric Primary Care (SICuPP), of the Italian Federation of Pediatric Doctors (FIMP) and of the Syndicate of Family Pediatrician Doctors (SIMPeF).

Technological innovation can contribute to a reorganization of healthcare, particularly by supporting the shift in the focus of care from the hospital to the territory, through innovative citizen-centered models, and facilitating access to services in the territory. Health and social care delivery modalities, enabled by telemedicine, are crucial in this regard. The objective of this Consensus document, written by the main Italian Scientific Societies involved in the use of telemedicine in pediatrics, is to define a standard for its use at the territorial level in various declinations in the pediatric field; this paper also identifies priority areas for its application and the types of services that most require intervention and investment. The changes that are underway in digital transformation in all sectors are unstoppable, and for the digital transformation to take place in a productive sense, the contribution of not only all health professionals, but also of patients, is necessary. From this perspective, authors from different backgrounds were involved in the drafting of this Consensus and, in the future, other figures, primarily patients, are expected to be involved. In fact, this belongs to the vision of connected care, in which the citizen/patient actively participates in the treatment path so that they are assisted in a personalized, predictive and preventive way. The future scenario must be able to provide for the involvement of patients from the initial stages of planning any treatment path, even in the pediatric age, and increasing, where possible, the proximity of the health service to the families.

Use of Telemedicine Healthcare Systems in Children and Adolescents with Chronic Disease or in Transition Stages of Life: Consensus Document of the Italian Society of Telemedicine (SIT), of the Italian Society of Preventive and Social Pediatrics (SIPPS), of the Italian Society of Pediatric Primary Care (SICuPP), of the Italian Federation of Pediatric Doctors (FIMP) and of the Syndicate of Family Pediatrician Doctors (SIMPeF).

Telemedicine is considered an excellent tool to support the daily and traditional practice of the health profession, especially when referring to the care and management of chronic patients. In a panorama in which chronic pathologies with childhood onset are constantly increasing and the improvement of treatments has allowed survival for them into adulthood, telemedicine and remote assistance are today considered effective and convenient solutions both for the chronic patient, who thus receives personalized and timely assistance, and for the doctors, who reduce the need for direct intervention, hospitalizations and consequent management costs. This Consensus document, written by the main Italian Scientific Societies involved in the use of telemedicine in pediatrics, has the objectives to propose an organizational model based on the relationships between the actors who participate in the provision of a telemedicine service aimed at minors with chronic pathologies, identifying specific project links between the areas of telemedicine in the developmental age from the first 1000 days of life to the age adult. The future scenario will have to be able to integrate digital innovation in order to offer the best care to patients and citizens. It will have to be able to provide the involvement of patients from the very beginning of the design of any care pathway, increasing where possible the proximity of the health service to citizens.

Information and Training on the Use of Telemedicine in Pediatric Population: Consensus Document of the Italian Society of Telemedicine (SIT), of the Italian Society of Preventive and Social Pediatrics (SIPPS), of the Italian Society of Pediatric Primary Care (SICuPP), of the Italian Federation of Pediatric Doctors (FIMP), and of the Syndicate of Family Pediatrician Doctors (SIMPeF).

Telemedicine has entered the daily lives of doctors, although the digital skills of healthcare professionals still remain a goal to be achieved. For the purpose of a large-scale development of telemedicine, it is necessary to create trust in the services it can offer and to favor their acceptance by healthcare professionals and patients. In this context, information for the patient regarding the use of telemedicine, the benefits that can be derived from it, and the training of healthcare professionals and patients for the use of new technologies are fundamental aspects. This consensus document is a commentary that has the aim of defining the information on and training aspects of telemedicine for pediatric patients and their caregivers, as well as pediatricians and other health professionals who deal with minors. For the present and the future of digital healthcare, there is a need for a growth in the skills of professionals and a lifelong learning approach throughout the professional life. Therefore, information and training actions are important to guarantee the necessary professionalism and knowledge of the tools, as well as a good understanding of the interactive context in which they are used. Furthermore, medical skills can also be integrated with the skills of various professionals (engineers, physicists, statisticians, and mathematicians) to birth a new category of health professionals responsible for building new semiotics, identifying criteria for predictive models to be integrated into clinical practice, standardizing clinical and research databases, and defining the boundaries of social networks and new communication technologies within health services.

Development and Validation of a Novel Pre-Pregnancy Score Predictive of Preterm Birth in Nulliparous Women Using Data from Italian Healthcare Utilization Databases.

Background: Preterm birth is a major worldwide public health concern, being the leading cause of infant mortality. Understanding of risk factors remains limited, and early identification of women at high risk of preterm birth is an open challenge. Objective: The aim of the study was to develop and validate a novel pre-pregnancy score for preterm delivery in nulliparous women using information from Italian healthcare utilization databases. Study Design: Twenty-six variables independently able to predict preterm delivery were selected, using a LASSO logistic regression, from a large number of features collected in the 4 years prior to conception, related to clinical history and socio-demographic characteristics of 126,839 nulliparous women from Lombardy region who gave birth between 2012 and 2017. A weight proportional to the coefficient estimated by the model was assigned to each of the selected variables, which contributed to the Preterm Birth Score. Discrimination and calibration of the Preterm Birth Score were assessed using an internal validation set (i.e., other 54,359 deliveries from Lombardy) and two external validation sets (i.e., 14,703 and 62,131 deliveries from Marche and Sicily, respectively). Results: The occurrence of preterm delivery increased with increasing the Preterm Birth Score value in all regions in the study. Almost ideal calibration plots were obtained for the internal validation set and Marche, while expected and observed probabilities differed slightly in Sicily for high Preterm Birth Score values. The area under the receiver operating characteristic curve was 60%, 61% and 56% for the internal validation set, Marche and Sicily, respectively. Conclusions: Despite the limited discriminatory power, the Preterm Birth Score is able to stratify women according to their risk of preterm birth, allowing the early identification of mothers who are more likely to have a preterm delivery.

Opioids for newborn infants receiving mechanical ventilation.

BACKGROUND: Mechanical ventilation is a potentially painful and discomforting intervention that is widely used in neonatal intensive care. Newborn infants demonstrate increased sensitivity to pain, which may affect clinical and neurodevelopmental outcomes. The use of drugs that reduce pain might be important in improving survival and neurodevelopmental outcomes. OBJECTIVES: To determine the benefits and harms of opioid analgesics for neonates (term or preterm) receiving mechanical ventilation compared to placebo or no drug, other opioids, or other analgesics or sedatives. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 9), in the Cochrane Library; MEDLINE via PubMed (1966 to 29 September 2020); Embase (1980 to 29 September 2020); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to 29 September 2020). We searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials comparing opioids to placebo or no drug, to other opioids, or to other analgesics or sedatives in newborn infants on mechanical ventilation. We excluded cross-over trials. We included term (≥ 37 weeks' gestational age) and preterm (< 37 weeks' gestational age) newborn infants on mechanical ventilation. We included any duration of drug treatment and any dosage given continuously or as bolus; we excluded studies that gave opioids to ventilated infants for procedures. DATA COLLECTION AND ANALYSIS: For each of the included trials, we independently extracted data (e.g. number of participants, birth weight, gestational age, types of opioids) using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria and assessed the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). We evaluated treatment effects using a fixed-effect model with risk ratio (RR) for categorical data and mean difference (MD) for continuous data. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We included 23 studies (enrolling 2023 infants) published between 1992 and 2019. Fifteen studies (1632 infants) compared the use of morphine or fentanyl versus placebo or no intervention. Four studies included both term and preterm infants, and one study only term infants; all other studies included only preterm infants, with five studies including only very preterm infants. We are uncertain whether opioids have an effect on the Premature Infant Pain Profile (PIPP) Scale in the first 12 hours after infusion (MD -5.74, 95% confidence interval (CI) -6.88 to -4.59; 50 participants, 2 studies) and between 12 and 48 hours after infusion (MD -0.98, 95% CI -1.35 to -0.61; 963 participants, 3 studies) because of limitations in study design, high heterogeneity (inconsistency), and imprecision of estimates (very low-certainty evidence - GRADE). The use of morphine or fentanyl probably has little or no effect in reducing duration of mechanical ventilation (MD 0.23 days, 95% CI -0.38 to 0.83; 1259 participants, 7 studies; moderate-certainty evidence because of unclear risk of bias in most studies) and neonatal mortality (RR 1.12, 95% CI 0.80 to 1.55; 1189 participants, 5 studies; moderate-certainty evidence because of imprecision of estimates). We are uncertain whether opioids have an effect on neurodevelopmental outcomes at 18 to 24 months (RR 2.00, 95% CI 0.39 to 10.29; 78 participants, 1 study; very low-certainty evidence because of serious imprecision of the estimates and indirectness). Limited data were available for the other comparisons (i.e. two studies (54 infants) on morphine versus midazolam, three (222 infants) on morphine versus fentanyl, and one each on morphine versus diamorphine (88 infants), morphine versus remifentanil (20 infants), fentanyl versus sufentanil (20 infants), and fentanyl versus remifentanil (24 infants)). For these comparisons, no meta-analysis was conducted because outcomes were reported by one study. AUTHORS' CONCLUSIONS: We are uncertain whether opioids have an effect on pain and neurodevelopmental outcomes at 18 to 24 months; the use of morphine or fentanyl probably has little or no effect in reducing the duration of mechanical ventilation and neonatal mortality. Data on the other comparisons planned in this review (opioids versus analgesics; opioids versus other opioids) are extremely limited and do not allow any conclusions. In the absence of firm evidence to support a routine policy, opioids should be used selectively - based on clinical judgement and evaluation of pain indicators - although pain measurement in newborns has limitations.

Managerial features and outcome in neonatal intensive care units: results from a cluster analysis.

BACKGROUND: Healthcare organisations differ in performance even if they are located in the same country or region. Suitable managerial practices and organisational processes can lead to better health outcomes. As a result, hospitals are constantly looking for managerial arrangements that can improve outcomes and keep costs down. This study aims to identify different managerial models in neonatal intensive care units (NICUs) and their impact on a large number of outcomes. METHODS: The research was conducted in Italy, within the SONAR project. SONAR's aim was to identify the characteristics of NICUs, monitor outcomes and promote best practices. This study includes 51 of the 63 NICUs that took part in the SONAR project. Questionnaires on the activities and managerial features were administered to doctors and nurses working in NICUs. A total of 643 questionnaires were analysed from doctors and a total of 1601 from nurses. A cluster analysis was performed to identify managerial models of NICUs. RESULTS: Three managerial models emerged from cluster analysis: traditional, collaborative and individualistic. In the "traditional" model the doctor is above the nurse in the hierarchy, and the nurse therefore has exclusively operational autonomy. The "collaborative" model has as key elements professional specialisation and functional coordination. The "individualistic" model considers only individual professional skills and does not concern the organisational conditions necessary to generate organisational effectiveness. The results also showed that there is an association between managerial model and neonatal outcomes. The collaborative model shows best results in almost all outcomes considered, and the traditional model has the worst. The individualistic model is in the middle, although its values are very close to those of traditional model. CONCLUSIONS: Health management needs to assess NICU strategically in order to develop models to improve outcomes. This study provides insights for management useful for designing managerial characteristics of NICUs in order to achieve better results. NICUs characterised by a collaborative model in fact show better neonatal outcomes.

Use of antidepressants during pregnancy and neonatal outcomes: An umbrella review of meta-analyses of observational studies.

BACKGROUND: Pregnant women who suffer from depressive disorders are likely to be treated with antidepressant (AD) medications. Recent meta-analyses underlined the possible relation between AD use and several neonatal outcomes, although the underlying mechanisms remains unclear. METHODS: To summarise and evaluate the associations between AD use in pregnancy and neonatal outcomes, we conducted an umbrella review of meta-analyses of observational studies published up to December 2019 in PubMed and Embase. Summary risk estimates for the associations between use of AD as a whole, or specific AD classes and drugs, and the risk of neonatal outcomes were reported. RESULTS: Our review included 22 meta-analyses investigating 69 associations. However, none were supported by convincing evidence. Highly suggestive evidence regarded the associations between (i) any time AD exposure and the risk of preterm birth (relative risk, 1.68; 95% confidence interval 1.52, 1.86), (ii) any time exposure to selective serotonin reuptake inhibitors (SSRIs) and the risk of preterm birth (1.43; 1.22, 1.37) and (iii) respiratory distress (1.33; 1.14, 1.55), and (iv) SSRI exposure during the first trimester of pregnancy and the risk of cardiovascular malformations (1.25; 1.13, 1.39). Suggestive evidence was obtained for any time AD exposure on 1-min low Apgar score (absolute average difference, -0.34; -0.53, -0.14). CONCLUSIONS: Overall, the effects of AD exposure during pregnancy on neonatal outcomes have been extensively studied, but few of the associations are graded as high quality evidence. More prospective studies and large collaborations with comprehensive standardised reporting of analyses are needed.

Association between Adherence with Recommended Antenatal Care in Low-Risk, Uncomplicated Pregnancy, and Maternal and Neonatal Adverse Outcomes: Evidence from Italy.

Antenatal care (ANC) aims of monitoring wellbeing of mother and foetus during pregnancy. We validate a set of indicators aimed of measuring the quality of ANC of women on low-risk, uncomplicated pregnancy through their relationship with maternal and neonatal outcomes. We conducted a population-based cohort study including 122,563 deliveries that occurred between 2015 and 2017 in the Lombardy Region, Italy. Promptness and appropriateness of number and timing of gynaecological visits, ultrasounds and laboratory tests were evaluated. We assessed several maternal and neonatal outcomes. Log-binomial regression models were used to estimate prevalence ratio (PR), and corresponding 95% confidence interval (95% CI), for the exposure→outcome association. Compared with women who adhered with recommendations, those who were no adherent had a significant higher prevalence of maternal intensive care units admission (PR: 3.1, 95%CI: 1.2-7.9; and 2.7, 1.1-7.0 respectively for promptness of gynaecological visits, and appropriateness of ultrasound examinations), low Apgar score (1.6, 1.1-1.2; 1.9, 1.3-2.7; and 2.1, 1.5-2.8 respectively for appropriateness and promptness of gynaecological visits, and appropriateness of ultrasound examinations), and low birth weight (1.8, 1.5-2.3 for appropriateness of laboratory test examinations). Benefits for mothers and newborn are expected from improving adherence to guidelines-driven recommendations regarding antenatal care even for low-risk, uncomplicated pregnancies.

Antenatal Corticosteroid Prophylaxis in Singleton and Multiple Pregnancies.

BACKGROUND: The effects of antenatal corticosteroids (ANS) in multiple pregnancies are disputed. In this article, we examined whether estimated effects differ in singletons and multiples and in small for gestational age (SGA) preterm infants. METHODS: We studied 17 073 singletons (81% treated with ANS) and 8274 multiples (86% treated) born at 24-33 weeks from the Italian Neonatal Network (2005-2013). We used Poisson regression models with robust variance to estimate adjusted risk ratios (RR) of in-hospital death, severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), and the composite outcome of severe IVH and death. RESULTS: Mortality was lower among ANS-treated vs. ANS-untreated infants, both in singletons (RR 0.63, 95% confidence interval (CI) 0.58, 0.68) and in multiples (RR 0.85, 95% CI 0.73, 0.98). IVH and the composite outcome of IVH and death, but not PVL, also occurred less frequently among ANS-treated infants. For these outcomes, the effect of ANS was stronger in singletons than in multiples (+35%, +32%, and +22% for death, IVH, and the composite outcome, respectively). Also among SGA infants, singletons, and multiples, ANS-treated infants had lower risk of death, IVH and of composite outcome than untreated ones. CONCLUSIONS: In this large cohort of preterm infants, both multiples and singletons treated with ANS had a lower risk of mortality, of severe IVH, and of composite outcome of IVH and death, both in the overall sample and in SGA infants. Although ANS effect was weaker in multiples, our results support current recommendations to administer ANS prophylaxis in multiple pregnancies at risk of preterm delivery.

Correction: Mortality and Length of Stay of Very Low Birth Weight and Very Preterm Infants: A EuroHOPE Study.

[This corrects the article DOI: 10.1371/journal.pone.0131685.].

Neonatal respiratory distress syndrome: are risk factors the same in preterm and term infants?

OBJECTIVE: To analyze respiratory distress syndrome (RDS) incidence and risk factors at different gestational age. METHODS: We considered data from 321 327 infants born in Lombardy, a Northern Italian Region. We computed multivariate analysis to identify risk factors for RDS by dividing infants in early- and moderate-preterm, late-preterm and term infants. RESULTS: Low-birth weight is the main risk factor for RDS, with higher odds ratio in term births. The risk was higher in infants delivered by cesarean section and in male, for all gestational age. Pathological course of pregnancy resulted in increased risk only in late-preterm and term infants. Maternal age and multiple birth were not associated with increased risk in any group. Babies born at term after assisted conception were at higher risk of RDS. CONCLUSION: Our analysis suggests as some risk factors do not influence RDS incidence in the same way at different gestational age.

Does quality of developmental care in NICUs affect health-related quality of life in 5-y-old children born preterm?

BACKGROUND: Preterm birth and Neonatal Intensive Care Unit (NICU) stay are early adverse experiences, which may affect health-related quality of life (HRQoL) even in the absence of prematurity-related morbidities. The aim of this multicenter longitudinal study was to examine the relation between quality levels of NICU Developmental Care (DC) and HRQoL at 60 mo in children who were born preterm. METHODS: HRQoL of 102 very preterm (VPT) children from 20 NICUs and 110 full-term controls was assessed using TNO-AZL Preschool Children's Quality of Life Questionnaire (TAPQOL). In VPT children, we compared HRQoL by splitting NICUs into units with high- and low-quality of DC according to the following two factors: (i) the infant centered care (ICC), and (ii) the infant pain management (IPM). RESULTS: Compared to VPT children from NICUs with high-quality of ICC, VPT children from NICUs with low-quality in ICC scored lower in HRQoL component which resulted from the aggregation of lively, positive emotionality, social and motor functioning. No differences were found between VPT children from high-quality ICC NICUs and full-term children and for the IPM index. CONCLUSION: Findings suggest that higher quality of DC in NICU related to ICC might mitigate long-term negative quality of life outcomes.

Work environment, volume of activity and staffing in neonatal intensive care units in Italy: results of the SONAR-nurse study.

BACKGROUND: Neonatal units' volume of activity, and other quantitative and qualitative variables, such as staffing, workload, work environment, care organization and geographical location, may influence the outcome of high risk newborns. Data about the distribution of these variables and their relationships among Italian neonatal units are lacking. METHODS: Between March 2010-April 2011, 63 neonatal intensive care units adhering to the Italian Neonatal Network participated in the SONAR Nurse study. Their main features and work environment were investigated by questionnaires compiled by the chief and by physicians and nurses of each unit. Twelve cross-sectional monthly-repeated surveys on different shifts were performed, collecting data on number of nurses on duty and number and acuity of hospitalized infants. RESULTS: Six hundred forty five physicians and 1601 nurses compiled the questionnaires. In the cross-sectional surveys 702 reports were collected, with 11082 infant and 3226 nurse data points. A high variability was found for units' size (4-50 total beds), daily number of patients (median 14.5, range 3.4-48.7), number of nurses per shift (median 4.2, range 0.7-10.8) and number of team meetings per month. Northern regions performed better than Central and Southern regions for frequency of training meetings, qualitative assessment of performance, motivation within the unit and nursing work environment; mean physicians' and nurses' age increased moving from North to South. After stratification by terciles of the mean daily number of patients, the median number of nurses per shift increased at increasing volume of activity, while the opposite was found for the nurse-to-patient ratio adjusted by patients' acuity. On average, in units belonging to the lower tercile there was 1 nurse every 2.5 patients, while in those belonging to the higher tercile the ratio was 1 nurse every 5 patients. CONCLUSIONS: In Italy, there is a high variability in organizational characteristics and work environment among neonatal units and an uneven distribution of human resources in relation to volume of activity, suggesting that the larger the unit the greater the workload for each nurse. Urgent modifications in planning and organization of services are needed in order to pursue more efficient, homogeneous and integrated regionalized neonatal care systems.

What we talk about when we talk about NICUs: infants' acuity and nurse staffing.

OBJECTIVE: Organizational features of neonatal intensive care influence the care of sick neonates. We estimated the acuity-adjusted nurse-to-patient ratio (NPR) in a national sample of Italian NICUs and factors influencing it. METHODS: Twelve monthly cross-sectional surveys were prospectively carried out in 63 NICUs. Number and acuity of infants, and number of nurses were recorded. Infants' acuity was assessed by Rogowki's 2013 and British Association for Perinatal Medicine 2001 classifications. RESULTS: We collected 702 reports regarding 11 082 infants. Non-intensive infants represented about 75% of NICU residents. Very preterm infants (<1501 g birth weight or <30 weeks gestation) represented 10.8% of admissions, but 44% of all infants surveyed. Average acuity-adjusted NPR was 0.31 (interquartile range 0.28-0.38); NPR depended on case-mix (proportion of intensive infants), size of the unit (larger units had a lower NPR) and was higher during morning shifts (+18%). Clustering on hospitals, reflecting shared components within each hospital, explained 47% of the variability of NPR. CONCLUSIONS: The majority of infants cared for in NICUs are not intensive. NPR is influenced by acuity of infants, size of units, shifts, but is largely due to other unobserved hospital-related organizational features.

Cost of care and social consequences of very low birth weight infants without premature- related morbidities in Italy.

Aim of this study was to estimate the cost that is borne by the Italian National Health Service, families, and social security due to very low birth weight infants (VLBWIs) without prematurity-related morbidities up to the age of 18 months. We followed up on 150 VLBWIs and 145 comparable full-term infants (FTIs) who were born in one of 25 different neonatal intensive care units upon discharge from the hospital and at six and 18 months of age. The average length of the primary hospitalisation of the VLBWIs was 59.7 days (SD 21.6 days), with a total cost of €20,502 (SD €8409), compared with three days (SD 0.4 days) with a total cost of €907 (SD €304) for the FTIs. The total societal cost of the VLBWIs for the first 18 months of life was €58,098 (SD €21,625), while the corresponding figure for FTIs was €24,209 (SD €15,557). Among VLBWIs, both low birth weight and gestational age were correlated with the length of hospitalisation after birth (r(2) = 0.61 and r(2) = 0.57, respectively; p values < 0.0005). Our findings highlight that the existing DRGs and tariffs inadequately reflect the actual costs for Italian National Health Service.

Mortality and Length of Stay of Very Low Birth Weight and Very Preterm Infants: A EuroHOPE Study.

The objective of this paper was to compare health outcomes and hospital care use of very low birth weight (VLBW), and very preterm (VLGA) infants in seven European countries. Analysis was performed on linkable patient-level registry data from seven European countries between 2006 and 2008 (Finland, Hungary, Italy (the Province of Rome), the Netherlands, Norway, Scotland, and Sweden). Mortality and length of stay (LoS) were adjusted for differences in gestational age (GA), sex, intrauterine growth, Apgar score at five minutes, parity and multiple births. The analysis included 16,087 infants. Both the 30-day and one-year adjusted mortality rates were lowest in the Nordic countries (Finland, Sweden and Norway) and Scotland and highest in Hungary and the Netherlands. For survivors, the adjusted average LoS during the first year of life ranged from 56 days in the Netherlands and Scotland to 81 days in Hungary. There were large differences between European countries in mortality rates and LoS in VLBW and VLGA infants. Substantial data linkage problems were observed in most countries due to inadequate identification procedures at birth, which limit data validity and should be addressed by policy makers across Europe.

Mode of delivery and level of neonatal care in Lombardy: a descriptive analysis according to volume of care.

BACKGROUND: Using data from the Hospital Discharge data-base (SDO) and from the Certificate of Delivery Assistance data-base (CedAP) we analysed mode of delivery and neonatal care in public and private hospitals in Lombardy Region during 2012. METHODS: In Lombardy a standard form is used to register all discharges from public or private hospitals (the SDO data-base which contained information on inpatient activity provided to each patient by any hospital or clinic included in the Regional Health System. Further, information on maternal characteristics and pregnancy outcome are available for all deliveries in CedAP data-base. We obtained data regarding all deliveries (mother discharge data-base M-SDO)and newborns discharge (N-SDO) and the CedAP data-base over the period January-December 2012 by the Lombardy Health Directorate. After linkage (using an anonymous key) of the three data-base using anonymized codes we obtained a data-base by the linkage of CedAP and N-SDO records, which includes, after elimination of incorrect codes, information on 90863 neonates and a data-base obtained by the linkage of CedAP and M-SDO records, which includes information on 90868 mother and deliveries. Using these data-base we have analysed mode of delivery and neonatal care in Lombardy according to the volume of care (VoC = number of delivery per year in the care unit). RESULTS: In 2012, in Lombardy, less than 3% of newborns were born in hospitals reporting less than 500 deliveries/year and less than 30% in hospitals reporting < 1000 deliveries per year. Cesarean section rate was higher in units reporting less than 1000 deliveries/year (28.7% versus 27.5% in hospitals with more than 1000 deliveries/year). In hospitals reporting 500, 500-799, 800-999 deliveries/year the percentage of preterm births with gestational age <33 weeks ranged from 0.1% to 0.2%, but was 3.4% in hospitals reporting 2500 deliveries per year or more. A total of 0.6% of newborns weighing less than 1000 grams and 3.2% of newborns with birth weight between 1000 and 1499 grams was born in hospitals which reported 1000 deliveries or more. CONCLUSIONS: This article provides an overview of delivery and neonatal care in the Lombardy Region with a focus on volume of care.

Association of maternal hypertension and chorioamnionitis with preterm outcomes.

OBJECTIVES: We compared the relative effect of hypertensive disorders of pregnancy and chorioamnionitis on adverse neonatal outcomes in very preterm neonates, and studied whether gestational age (GA) modulates these effects. METHODS: A cohort of neonates 23 to 30 weeks' GA, born in 2008 to 2011 in 82 hospitals adhering to the Italian Neonatal Network, was analyzed. Infants born from mothers who had hypertensive disorders (N = 2096) were compared with those born after chorioamnionitis (N = 1510). Statistical analysis employed logistic models, adjusting for GA, hospital, and potential confounders. RESULTS: Overall mortality was higher after hypertension than after chorioamnionitis (odds ratio [OR], 1.39; 95% confidence interval [CI], 1.08-1.80), but this relationship changed across GA weeks; the OR for hypertension was highest at low GA, whereas from 28 weeks' GA onward, mortality was higher for chorioamnionitis. For other outcomes, the relative risks were constant across GA; infants born after hypertension had an increased risk for bronchopulmonary dysplasia (OR, 2.20; 95% CI, 1.68-2.88) and severe retinopathy of prematurity (OR, 1.48; 95% CI, 1.02-2.15), whereas there was a lower risk for early-onset sepsis (OR, 0.25; 95% CI, 0.19-0.34), severe intraventricular hemorrhage (OR, 0.65; 95% CI, 0.48-0.88), periventricular leukomalacia (OR, 0.70; 95% CI, 0.48-1.01), and surgical necrotizing enterocolitis or gastrointestinal perforation (OR, 0.47; 95% CI, 0.31-0.72). CONCLUSIONS: Mortality and other adverse outcomes in very preterm infants depend on antecedents of preterm birth. Hypertension and chorioamnionitis are associated with different patterns of outcomes; for mortality, the effect changes across GA weeks.

Changes in ventilator strategies and outcomes in preterm infants.

BACKGROUND: Although life-saving, intubation and mechanical ventilation can lead to complications including bronchopulmonary dysplasia (BPD). In order to reduce the incidence of BPD, non-invasive ventilation (NIV) is increasingly used. OBJECTIVE: The aim of our study was to describe changes in ventilator strategies and outcomes between 2006 and 2010 in the Italian Neonatal Network (INN). DESIGN: Multicentre cohort study. SETTINGS: 31 tertiary level neonatal units participating in INN in 2006 and 2010. PATIENTS: 2465 preterm infants 23-30 weeks gestational age (GA) without congenital anomalies. MAIN OUTCOMES MEASURES: Death, BPD and other variables defined according to Vermont Oxford Network. Logistic regressions, adjusting for confounders and clustering for hospitals, were used. RESULTS: Similar numbers of infants were studied between 2006 and 2010 (1234 in 2006 and 1231 in 2010). The baseline risk of populations studied (GA, birth weight and Vermont Oxford Network Risk-Adjustment score) did not change. After adjusting for confounding variables, infants receiving invasive mechanical ventilation decreased (OR=0.72, 95% CI 0.58 to 0.89) while NIV increased (OR=1.75, 95% CI 1.39 to 2.21); intubation in delivery room decreased (OR=0.64, 95% CI 0.51 to 0.79). Considering outcomes, there was a significant reduction in mortality (OR=0.73, 95% CI 0.55 to 0.96) and in the combined outcome mortality or BPD (OR=0.76, 95% CI 0.62 to 0.94). CONCLUSIONS: Despite a stable baseline risk, from 2006 to 2010, we observed a lower level of invasiveness, a reduction of mechanical ventilation and an increase of NIV use, and this was accompanied by a decrease in risk-adjusted mortality and BPD.

Survey of neonatal respiratory care and surfactant administration in very preterm infants in the Italian Neonatal Network.

INTRODUCTION: Variation of respiratory care is described between centers around the world. The Italian Neonatal Network (INN), as a national group of the Vermont-Oxford Network (VON) allows to perform a wide analysis of respiratory care in very low birth weight infants. METHODS: We analyzed the dataset of infants enrolled in the INN in 2009 and 2010 and, for surfactant administration only, from 2006 to 2010 from 83 participating centers. All definitions are those of the (VON). A questionnaire analysis was also performed with a questionnaire on centers practices. RESULTS: We report data for 8297 infants. Data on ventilator practices and outcomes are outlined. Variation for both practices and outcome is found. Trend in surfactant administration is also analyzed. CONCLUSIONS. The great variation across hospitals in all the surveyed techniques points to the possibility of implementing potentially better practices with the aim of reducing unwanted variation. These data also show the power of large neonatal networks in identifying areas for potential improvement.