Parental practices that influence children's development: how often are they implemented and by whom-results from the NASCITA birth cohort study.

This study aims to assess how commonly 15 parental practices, known to have positive effects on child and adult health, are carried out by families in Italy, if they are related, and which characteristics are associated with implementation. Children participating in the NASCITA Cohort, a prospective study in which family pediatricians in Italy collect data on children and their families, were included if they had sufficient data. Data on practice implementation, socio-demographic characteristics, and interrelatedness between practices were analyzed. In all, 3337 children were included. Their mothers had an average age at birth of 33 years (range 17-52) and medium-high levels of education (86% of mothers) and employment (72%). No smoking or alcohol in pregnancy, supine infant sleeping position, and tummy time were the most commonly implemented practices (by over 85% of mothers, each), while the least common was exclusive breastfeeding at 6 months (28%). Parental practices are related and several socio-demographic characteristics influence their implementation, with mother's educational level and geographic area of residence influencing most of the practices (each influencing 12 of 15 practices). Low educational level (OR 0.34; 95% CI 0.26-0.44), being born abroad (OR 0.43; 95% CI 0.34-0.56), and residing in the South (OR 0.49; 95% CI 0.41-0.58) most reduce the probability of implementing numerous supportive practices (all three P < 0.001).    Conclusion: Socio-demographic factors contribute significantly to carrying out supportive practices. Future interventions should address the identified inequalities, prioritizing families most in need. Direct involvement of pediatricians is warranted given their favorable position for promoting positive behaviors. What is Known: • Several parental actions in the early life of a child are known to have positive effects on later child health and development. • While folic acid supplementation and exclusive breastfeeding have been promoted for years, other supporting actions are less well-known. What is New: • Rates of parental adherence to the different supportive actions varied greatly and actions were often scantly adopted. • Socio-demographic characteristics influenced adherence, with young, unemployed mothers with low educational levels, living in the South, or who were born abroad adhering significantly less.

Pediatrician and parental evaluation of child neurodevelopment at 2 years of age.

BACKGROUND: The early identification of infants with a risk for neurodevelopmental disorders in the first few years of life is essential for better developmental outcomes. Screenings should be carried out by combining the family pediatricians' and parents' perspectives, the two fundamental sources of information on children's health. The present study has three aims: (a) to test the feasibility of parent-report instruments to detect warning signs in their children's development; (b) to ascertain whether there is an agreement between the family pediatricians' (FP) clinical judgments of warning signs and the parental perceptions; (c) to determine whether there is a link between parents' distress and child development. METHODS: Within the NASCITA birth cohort, in addition to the family pediatrician's clinical evaluation with routine tools, the Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) was completed by parents to assess the child's language, social skills, behavior, and sensory areas. Parents were also asked to complete the Parenting Stress Index, Short Form (PSI-SF) to verify the magnitude of stress in the parent-child system. Univariate and multivariate analyses were performed to evaluate the association between child and parental characteristics and the presence of warning signs. RESULTS: The follow-up assessment was completed for 435 infants: 69 (15.8%) presented warning signs: 43 in the pediatrician's assessment and 36 in the M-CHAT-R (10 in both). A total of 16 children (14 with warning signs) received a diagnosis after a specialist evaluation. Being male (OR 2.46, 95%CI: 1.23-4.91) and having sleep disorders (OR 2.43, 95% CI 1.17-5.04) was associated with a greater likelihood of warning signs in the multivariate analysis, while reading aloud was a protective factor (not exposed versus exposed (OR = 3.14; 95% CI 1.60-6.17). For 73 children (18.4%), at least one parent tested positive for PSI-SF. An increased prevalence of parental distress was observed in children with warning signs (OR 2.36, 95% CI 1.27-4.37). CONCLUSIONS: Integrating physician and parental perspectives during well-child visits and in clinical practice appears feasible and can improve the identification of children at risk of developmental disorders.

Psychological distress among Italians during the 2019 coronavirus disease (COVID-19) quarantine.

BACKGROUND: Quarantine as a preventive action to reduce people's exposure to a contagious disease has substantial psychological impact. We aimed to collect information on psychologically distressing experiences of Italians living in quarantine during the COVID-19 pandemic. METHODS: From 6 to 20 April 2020 participants filled out an online questionnaire. Demographic and physical symptoms data from the prior 14 days of quarantine were collected. Psychological impact of quarantine was assessed by the COVID-19 Peritraumatic Distress Index (CPDI). RESULTS: In all, 20,158 participants completed the online survey. Of these, 11,910 (59.1%) were from Lombardy, the region with 37.7% of positive cases identified during the survey period. 30.1% of responders were male. About half (55.9%) of responders were 18-50 years old, 54.3% had a tertiary level of education, 69.5% were workers, 84.1% were living in houses with ≥3 rooms, and 13.7% were living alone. 9.7% had had contact with COVID-19 positive people. Of all responders, 9978 (48.6%) reported a psychological impact, 8897 (43.4%) of whom reported mild or moderate and 1081 (5.2%) severe psychological impact. The multivariate analysis, after adjustments, showed that an increasing CPDI score was associated with gender (female), first-second educational level, being unemployed, living in a ≤2 room house, having had new health problems during the previous 14 days, and not having been out of the house in the previous week. Concerning the type of psychological distress, 2003 responders (9.9%) reported moderate to severe depressive symptoms, 1131 (5.5%) moderate to severe anxiety symptoms, and 802 (3.9%) moderate to severe physical symptoms. A positive correlation was found between responder rate (per 10.000 residents) and positive COVID-19 cases (per 10.000 residents) by region (rs = + 0.83, p = < 0.0001), and between responder rate and region latitude (rs = + 0.91, p = < 0.0001), with a greater response rate in the north. Considering Lombardy Region responders, a negative correlation between CPDI score and distance from place of residence to the red zone (Nembro-Alzano) was found. Higher prevalence of psychological distress was found up to 25 km away from the red zone and, in particular, severe distress up to 15 km. CONCLUSIONS: Policy makers and mental health professionals should be aware of quarantine's adverse mental health consequences. Factors influencing the success of quarantine and infection control practices for both disease containment and community recovery should be identified and additional support to vulnerable persons at increased risk of adverse psychological and social consequences of quarantine should be guaranteed.

Distance learning in Italian primary and middle school children during the COVID-19 pandemic: a national survey.

BACKGROUND: School closure created difficulties for parents, who were asked to care for their children and help them with schooling, while working at home. We aimed to explore the experiences in organising school for children at home and its implications on children's psychological well-being and educational progress during the quarantine for the COVID-19 pandemic. METHODS: A nationwide online survey of mothers of primary and middle school students was conducted during the COVID-19 pandemic. Demographic data and information on distance learning organisation and children's attitudes and behavioural changes were collected. RESULTS: 2149 mothers completed the survey, with a final sample of 1601 subjects. Large differences between primary and middle school emerged: lessons were less organised and routines were more instable for the youngest, who could not pay attention for more than 20 min (28.3%) and needed breaks every 10 min (21.6%), with lower quality of learning (40.6%), increased restlessness (69.1%), and aggressiveness (33.3%). A large use of screens was reported, with an abuse in screen time in 2%. Two thirds of mothers did not approve of distance learning (72.2%) because of their role in replacing teachers (77.8%), the effort required (66%), and the great commitment required (78.3%). CONCLUSIONS: Distance learning increased educational deprivation and social inequalities, especially for the youngest children, who lost almost one year of school. The situation was even worse for children with disabilities, who were neglected by the institutions. This period should be considered as an opportunity to correct the weaknesses of our school system.

Informatics Methodology Used in the Web-Based Portal of the NASCITA Cohort Study: Development and Implementation Study.

BACKGROUND: Many diseases occurring in adults can be pinned down to early childhood and birth cohorts are the optimal means to study this connection. Birth cohorts have contributed to the understanding of many diseases and their risk factors. OBJECTIVE: To improve the knowledge of the health status of Italian children early on and how it is affected by social and health determinants, we set up a longitudinal, prospective, national-level, population-based birth cohort, the NASCITA study (NAscere e creSCere in ITAlia). The main aim of this cohort is to evaluate physical, cognitive, and psychological development; health status; and health resource use in the first 6 years of life in newborns, and potential associated factors. A web-based system was set up with the aim to host the cohort; provide ongoing information to pediatricians and to families; and facilitate accurate data input, monitoring, and analysis. This article describes the informatics methodology used to set up and maintain the NASCITA cohort with its web-based platform, and provides a general description of the data on children aged over 7 months. METHODS: Family pediatricians were contacted for participation in the cohort and enrolled newborns from April 2019 to July 2020 at their first well-child visit. Information collected included basic data that are part of those routinely collected by the family pediatricians, but also parental data, such as medical history, characteristics and lifestyle, and indoor and outdoor environment. A specific web portal for the NASCITA cohort study was developed and an electronic case report form for data input was created and tested. Interactive data charts, including growth curves, are being made available to pediatricians with their patients' data. Newsletters covering the current biomedical literature on child cohorts are periodically being put up for pediatricians, and, for parents, evidence-based information on common illnesses and problems in children. RESULTS: The entire cohort population consists of 5166 children, with 139 participating pediatricians, distributed throughout Italy. The number of children enrolled per pediatrician ranged from 1 to 100. The 5166 enrolled children represent 66.55% (5166/7763) of the children born in all of 2018 covered by the same pediatricians participating in the cohort. The number of children aged over 7 months at the time of these analyses, and for whom the most complete data were available upon initial analyses, was 4386 (2226/4381 males [50.81%] and 142/4370 twins [3.25%]). The age of the mothers at birth of the 4386 children ranged from 16 to 54 years. Most newborns' mothers (3758/4367, 86.05%) were born in Italy, followed by mothers born in Romania (101/4367, 2.31%), Albania (75/4367, 1.72%), and Morocco (60/4367, 1.37%). Concerning the newborns, 138/4386 (3.15%) were born with malformations and 352/4386 (8.03%) had a disease, most commonly neonatal respiratory distress syndrome (n=52), neonatal jaundice (n=46), and neonatal hypoglycemia (n=45). CONCLUSIONS: The NASCITA cohort is well underway and the population size will permit significant conclusions to be drawn. The key role of pediatricians in obtaining clinical data directly, along with the national-level representativity, will make the findings even more solid. In addition to promoting accurate data input, the multiple functions of the web portal, with its interactive platform, help maintain a solid relationship with the pediatricians and keep parents informed and interested in participating. TRIAL REGISTRATION: ClinicalTrials.gov NCT03894566; https://clinicaltrials.gov/ct2/show/NCT03894566.

Evaluation of the Pattern of Use of a Pediatric Emergency Department in Italy.

OBJECTIVES: The aim of this study was to evaluate access to a pediatric emergency department (PED) in a large hospital, in particular to estimate the prevalence of potentially avoidable accesses and the characteristics of return visits. METHODS: Clinical health records from the PED of San Gerardo Hospital, Monza, Italy, were retrospectively reviewed. The study population was composed of subjects younger than 18 years who attended the PED during the period from October 1, 2017, to November 30, 2017.Accesses were defined nonurgent if characterized by white or green triage codes and patient's discharge as the outcome and were defined potentially avoidable if nonurgent and with no diagnostic/therapeutic procedures performed except a visit by the ED pediatrician.Return visits were defined as accesses that occurred within 72 hours of the first index visit. RESULTS: A total of 2064 children and adolescents younger than 18 years had at least 1 ED attendance between October and November 2017, for a total of 2364 accesses.The most frequent diagnoses were upper respiratory tract infections (29.5% of accesses), followed by gastroenteritis (7.0%) and abdominal pain (7.0%). In all, 1810 accesses (88%) were classified as "nonurgent," and 1228 (60%) potentially avoidable, 373 of which were probably avoidable because they occurred when the primary care physician was available.The number of return visits was 98 (5% of the accesses): 74 were nonurgent, 31 of which potentially avoidable. On 17 occasions, both index and return visits were potentially avoidable. CONCLUSIONS: We confirm that most of the accesses to a PED are nonurgent and potentially avoidable. Interventions are needed to improve the appropriateness of use of emergency services.

NASCITA Italian birth cohort study: a study protocol.

BACKGROUND: Young children's healthy development depends on nurturing care, which ensures health, nutrition, responsive caregiving, safety and security, and early learning. Infancy and childhood are characterized by rapid growth and development, and these two factors contribute largely to determining health status and well-being across the lifespan. Identification of modifiable risk factors and prognostic factors during the critical periods of life will contribute to the development of effective prevention and intervention strategies. The NASCITA (NAscere e creSCere in ITAlia) study was created to evaluate physical, cognitive, and psychological development, health status and health resource utilization during the first six years of life in a cohort of newborns, and to evaluate potential associated factors. METHODS: NASCITA is an ongoing, dynamic, prospective, population-based birth cohort study of an expected number of more than 5000 newborns who will be recruited in 22 national geographic clusters starting in 2019. It was designed to follow children from birth to school entry age for a wide range of determinants, disorders, and diseases. Recruitment of the newborns (and their parents) will take place during the first routine well-child visit, which takes place at the office of the pediatrician assigned to them by the local health unit of residence, and which is scheduled for all newborns born in Italy within the first 45 days of their life. Data will be web-based and collected by the family pediatricians during each of the 7 standard well-child visits scheduled for all children during their first 6 years of life. Information on every contact with the enrolled children in addition to these prescheduled visits will be also recorded. DISCUSSION: The NASCITA cohort study provides a framework in which children are followed from birth to six-years of age. NASCITA will broaden our understanding of the contribution of early-life factors to infant and child health and development. NASCITA provides opportunities to initiate new studies, also experimental ones, in parts of the cohort, and will contribute relevant information on determinants and health outcomes to policy and decision makers. Cohort details can be found on https://coortenascita.marionegri.it. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03894566. Ethics committee approval: 6 February 2019, Verbale N 59.

Waiting times for diagnosis of attention-deficit hyperactivity disorder in children and adolescents referred to Italian ADHD centers must be reduced.

BACKGROUND: To investigate timely access to and the time needed to complete the diagnostic path of children and adolescents with suspected attention deficit hyperactivity disorder (ADHD) in the 18 Italian Lombardy Region ADHD reference centers. METHODS: Data of children and adolescents enrolled in the Regional ADHD disease-oriented Registry for suspected ADHD who requested their first visit in 2013-2017 were analyzed. RESULTS: The sample comprised 2262 children and adolescents aged 5-17 years who accessed the ADHD centers for diagnostic classification and management. The median waiting time was of 177 days (range 66-375) from the request for the initial appointment to the completion of the diagnostic path, with a three - fold difference between centers. In addition to the center, the strongest significant predictors of long waiting times were age comorbidities, the severity of the disorder, and having already completed some diagnostic procedures provided by the common standard path. CONCLUSIONS: To guarantee an equal standard of care in ADHD centers for all children and adolescents there is a pressing need to reduce the times to complete the diagnostic path. It is the task of both policymakers and each center to optimize the quality of the service and of the care delivered.

Age level vs grade level for the diagnosis of ADHD and neurodevelopmental disorders.

A number of worldwide studies have demonstrated that children born later in the school year are more likely to receive an ADHD diagnosis than their same school-year peers. There is, however, variation in findings between countries. We aimed to confirm whether relative age is associated with ADHD diagnosis, with or without comorbidities, and to investigate whether relative age is associated with ADHD type and severity, and if this age relationship is in common with other neurodevelopmental disorder. We used the Lombardy Region's ADHD registry. Data on children aged 6 years and older from September 1, 2011 to December 31, 2017 were considered. We calculated incidence ratios to assess the inter-relations between relative age within the school year, using age at diagnosis of ADHD or of other psychiatric disorder, year of diagnosis, and total number of children born in Lombardy during the corresponding timeframe. Data on ADHD type, severity of diagnosed disorder clinical global impressions-severity scale, and repetition of a school-grade were also considered. 4081 children, 2856 of whom with ADHD, were identified. We confirmed that the cumulative incidence of ADHD diagnosis was greatest for younger children, in particular for boys, for whom the prevalence is greater. The relative age effect was not accounted for by ADHD comorbid disorders, ADHD of combined type or severity. The relative age effect was also observed for children with other neurodevelopmental disorders (without ADHD), with a similar profile as ADHD children: the incidence ratio was 1.78 (95% CI 1.07-2.97; p < 0.0247) for boys diagnosed before age ten. The findings have a potential implication for diagnostic and therapeutic practice, educational advice, and policies, besides to better plan and organize service systems and appropriately inform parents, children, and citizens.

Postnatal depression screening in a paediatric primary care setting in Italy.

BACKGROUND: Postnatal depression is a non-psychotic depressive disorder that begins within 4 weeks of childbirth and occurs in 13% of mothers and 10% of fathers. A prospective study with the aim to evaluate the prevalence of postnatal depression by screening parents with the Edinburgh Postnatal Depression Scale (EPDS) in the Italian paediatric primary care setting was performed. METHODS: Mothers and fathers of infants born between 1 February and 31 July 2012, living in Italy's Milan-1 local health unit area, represented the target population of this pilot study. Parents attending well-child visits at any of the family paediatricians' offices between 60 to 90 days postpartum were asked to participate in the screening and to fill out the EPDS questionnaire. A cut-off score of 12 was used to identify parents with postnatal depression symptoms. Maternal and paternal socio-demographic variables and information concerning pregnancy and delivery were also collected. To investigate the association between screening positivity (dependent variable) and socio-demographic variables and factors related to pregnancy and delivery, a Pearson's χ2 test was used. Moreover, a stepwise multivariate logistic regression was carried out to evaluate the risk factors that most influence the probability of suffering from postnatal depression. RESULTS: In all, 126 out of 2706 (4.7%, 95% CI 3.9-5.5%) mothers and 24 out of 1420 (1.7%, 95% CI 1.0-2.4%) fathers were found to be positive for depressive symptoms. Women with mood disorders and anxiety during pregnancy were at increased risk of postpartum depression (OR 22.9, 95% CI 12.1-43.4). Only 11 mothers (8.7%) positive to EPDS screening attended a psychiatric service, and for 8 of them the diagnosis of postnatal depression was confirmed. CONCLUSIONS: The prevalence of postnatal depression was lower than previously reported. Routine screening resulted ineffective, since few mothers found positive for depression symptoms decided to attend psychiatric services.

Emergency department visits in older people: pattern of use, contributing factors, geographical differences and outcomes.

AIMS: To assess the pattern of use of Emergency Departments (EDs), factors contributing to the visits, geographical distribution and outcomes in people aged 65 years or more living in the Italian Lombardy Region in 2012. METHODS: Based on an administrative database the study population was divided into groups according to the number of ED visits. A multinomial logistic regression model was performed to compare the characteristics of each group. The Getis-Ord's G statistic was used to evaluate the clusters of high and low visit prevalence odd ratios (OR) at district level. To estimate the severity of the disease leading to ED attendance, visits were stratified based on the level of emergency and outcome. RESULTS: About 2 million older people were included in the analyses: 78 % had no ED visit, 15 % only 1, 7 % 2 or more. Male sex, age 85 years or more, high number of drugs, ED visits and hospital admissions in the previous year and the location of an ED within 10 km from the patient's place were all factors associated with a higher risk to have more ED visits. Clusters of high and low prevalence of visits were found for occasional users. Overall, 83 % of ED visit with a low emergency triage code at admission had as visit outcome discharge at home. CONCLUSIONS: In older people several variables were associated with an increased risk to have a high number of ED visits. Most of the visits were done for non-urgent problems and significant geographic differences were observed for occasional users.

Comorbidity prevalence and treatment outcome in children and adolescents with ADHD.

Although ADHD comorbidity has been widely studied, some issues remain unsolved. This multicenter observational study aims to examine comorbid psychiatric disorders in a clinical sample of newly diagnosed, treatment naïve children and adolescents with and without ADHD and, to compare treatment efficacy based on the type of comorbidity. We performed an analysis of the medical records of patients identified from the Regional ADHD Registry database, enrolled in 18 ADHD centers in the 2011-2016 period. 1919 of 2861 subjects evaluated (67%) met the diagnostic criteria for ADHD: 650 (34%) had only ADHD, while 1269 (66%) had at least one comorbid psychiatric disorder (learning disorders, 56%; sleep disorders, 23%; oppositional defiant disorder, 20%; anxiety disorders, 12%). Patients with ADHD of combined type and with severe impairment (CGI-S ≥5) were more likely to present comorbidity. 382 of 724 (53%) followed up patients improved after 1 year of treatment. ADHD with comorbidity showed greater improvement when treated with combined interventions or methylphenidate alone. Specifically, combined treatment showed significant superiority for ADHD with learning disorders (ES 0.66) and ODD (ES 0.98), lower for ADHD with sleep or anxiety disorders. Training intervention alone showed only medium efficacy (ES 0.50) for ADHD and learning disorders. This study was the first describing comorbidity patterns of ADHD in Italy, confirming, in a multicenter clinical setting, that ADHD is more often a complex disorder. Findings highlight important diagnostic, therapeutic, and service organization aspects that should be broadly extended to ensure an appropriate and homogenous ADHD management.

Psychotropic medicine prescriptions in Italian youths: a multiregional study.

The aim of the study was to evaluate the trend of paediatric psychotropic drug prescriptions in Italy. Data sources were regional, outpatient prescription databases. Seven Italian regions, covering 50 % of the Italian population, provided data from 2006 to 2011. Prevalence and incidence of prescriptions by age and gender were evaluated for psychotropic, antidepressant, antipsychotic, and attention-deficit/hyperactivity disorders (ADHD) medications. The hospital admission rate for psychiatric conditions was calculated, also at the local health unit (LHU) level. The presence of trends in prescription prevalence and incidence during the 6 year period was assessed. Finally, the correlation between prevalence, prescription, hospital admission rates, latitude, longitude, and average annual income at the LHU level was also investigated. In 2011, 8834 youths received at least one psychotropic drug prescription, with a prevalence of 1.76 ‰ (95 % CI 1.72-1.80). The incidence of new psychotropic drug users was 1.03 ‰ (1.00-1.06). The prevalence of antidepressants was 1.02 ‰ (0.99-1.04), while that of antipsychotics was 0.70 ‰ (0.68-0.72), and that of ADHD medications 0.19 ‰ (0.18-0.21). The psychotropic drug prevalence increased with increasing age. Males were more exposed to psychotropic drugs than females (AUC0-17 male/female = 1.23). Antipsychotics were the most prescribed psychotropic drugs in males, while antidepressants were in females. Between-region prevalence ranged from 1.56 to 2.17 ‰. The overall prevalence of psychotropic drug from 2006 to 2011 was stable (χ(t)2 ≤ 0.001, p = 0.97). No correlation was found between prevalence and the variables investigated. Psychotropic drug prescription was very limited and stable. No geographical patterns were found.

Comparing recurrent antibiotic prescriptions in children treated with a brand name or a generic formulation.

PURPOSE: The aim of this study was to investigate the rate of recurrent prescriptions and hospital admissions in children receiving a brand name or generic antibiotic prescription. METHODS: The data source was a database of reimbursed prescriptions. Outpatient children/adolescents <18 years old (Lombardy Region, Italy) were included. The observational period was February-April 2010. A recurrence was defined as an antibiotic prescription occurring within 28 days after an index prescription. The rate of recurrent prescriptions and hospital admissions was calculated for generic/brand name formulations and for each age strata (0-5, 6-11, and 12-17 years old) for four antibiotics: amoxicillin, amoxicillin clavulanate, clarithromycin, and cefaclor. The percentage of therapy switches was calculated. Cochran-Mantel-Haenszel test was used to compare the age-adjusted outcomes. RESULTS: In all, 17.5% (57 346) of children received at least one recurrent prescription. The rate of recurrent prescriptions was slightly lower in children receiving any generic (OR 0.96; 95%CI 0.93-0.98), compared with any brand name, antibiotic. The percentage of hospital admissions occurring in children initially treated with a brand name (1.01%; 95%CI 0.98-1.08) or generic (1.03%; 0.96-1.06) antibiotic was not different (p = 0.43). For children receiving amoxicillin clavulanate, the hospital admission rate was slightly higher in the brand name group (p = 0.002), while no differences were found for the other active substances. CONCLUSIONS: Children treated with generic antibiotics had no worse safety and effectiveness outcomes when compared with those receiving brand name ones. These results provide additional evidence on the safety of generic antibiotics.

Impact of the systematic introduction of low-cost bubble nasal CPAP in a NICU of a developing country: a prospective pre- and post-intervention study.

BACKGROUND: The use of Nasal Continuous Positive Airway Pressure Ventilation (NCPAP) has begun to increase and is progressively replacing conventional mechanical ventilation (MV), becoming the cornerstone treatment for newborn respiratory distress syndrome (RDS). However, NCPAP use in Lower-Middle Income Countries (LMICs) is poor. Moreover, bubble NCPAP (bNCPAP), for efficacy, cost effectiveness, and ease of use, should be the primary assistance technique employed in newborns with RDS. OBJECTIVE: To measure the impact on in-hospital newborn mortality of using a bNCPAP device as the first intervention on newborns requiring ventilatory assistance. DESIGN: Prospective pre-intervention and post-intervention study. SETTING: The largest Neonatal Intensive Care Unit (NICU) in Nicaragua. PARTICIPANTS: In all, 230 (2006) and 383 (2008) patients were included. INTERVENTION: In May 2006, a strategy was introduced to promote the systematic use of bNCPAP to avoid intubation and MV in newborns requiring ventilatory assistance. Data regarding gestation, delivery, postnatal course, mortality, length of hospitalisation, and duration of ventilatory assistance were collected for infants assisted between May and December 2006, before the project began, and between May and December 2008, two years afterwards. OUTCOME MEASURES: The pre- vs post-intervention proportion of newborns who died in-hospital was the primary end point. Secondary endpoints included rate of intubation and duration of NICU stay. RESULTS: Significant differences were found in the rate of intubation (72 vs 39%; p < 0.0001) and the proportion of patients treated exclusively with bNCPAP (27% vs 61%; p <0.0001). Mortality rate was significantly reduced (40 vs 23%; p < 0.0001); however, an increase in the mean duration of NICU stay was observed (14.6 days in 2006 and 17.5 days in 2008, p = 0.0481). The findings contribute to the evidence that NCPAP, particularly bNCPAP, is the first-line standard of care for efficacy, cost effectiveness, and ease of use in newborns with respiratory distress in LMICs. CONCLUSIONS: This is the first extensive survey performed in a large NICU from a LMICs, proving the efficacy of the systematic use of a bNCPAP device in reducing newborn mortality. These findings are an incentive for considering bNCPAP as an elective strategy to treat newborns with respiratory insufficiency in LMICs.

Antibiotic and anti-asthmatic drug prescriptions in Italy: geographic patterns and socio-economic determinants at the district level.

PURPOSE: To analyse the prevalence rate of antibiotics and anti-asthmatics in children and adolescents at the healthcare district level. METHODS: Data sources were three regional prescription databases. A total of 175 healthcare districts (3.3 million children/adolescents) participated in the study, providing data for the year 2008. Prevalence rate was standardised by age. The ANOVA test was used to compare prevalence rates of districts in the three regions. The standardised prevalence ratio (SPR) was calculated for each district and a map of the index was elaborated. The correlation among latitude, average annual income per inhabitant, hospitalisation rate, number of paediatricians per 1,000 resident children and prevalence rate was evaluated by district (Spearman's test). RESULTS: The antibiotic prevalence rate was, on average, 47.9 % (34.0 to 67.9 % between districts), while the anti-asthmatic prevalence was 21.4 % (11.7-35.6 %). The prevalence was higher in districts from the southern regions (antibiotics F = 92.1, anti-asthmatics F = 107.5; p < 0.001). There was a significant correlation between the prevalence of antibiotics and anti-asthmatics (rS = 0.77 p < 0.001), and the prevalence of both was inversely related to latitude (respectively rS = -0.71, -0.72; p < 0.001) and average income (rS = -0.77, -0.73; p < 0.001). Children/adolescents living in districts in the lower quintile of average income were more exposed to antibiotic (OR = 1.75; 1.74-1.77) and anti-asthmatic (OR 1.56, 1.55-1.57) prescriptions. CONCLUSIONS: A lower income at the district level is related to higher antibiotic and anti-asthmatic drug prescription rates. Local socio-economic inequities can concur in prescribing distribution and must be considered when planning educational interventions to reduce over-prescription.

Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial.

Background: Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. Methods: We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). Findings: The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01-2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. Interpretation: As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice. Funding: The study was funded by the Italian Medicines Agency within the "2016 Call for Independent Drug Research".

Geographical differences in the prevalence of chronic polypharmacy in older people: eleven years of the EPIFARM-Elderly Project.

PURPOSE: To compare the geographical differences in the prevalence of chronic polypharmacy in community-dwelling older people over 11 years. METHODS: This study analyzed nearly two million patients aged 65-94 years recorded in the Drug Administrative Database of the Lombardy Region (Northern Italy) from 2000 to 2010. Chronic polypharmacy was defined as taking five or more drugs in 1 month for at least 6 months (consecutive or not) in a year. RESULTS: There was a significant spatial autocorrelation that increased at the municipality level from 2000 (Moran's I Index = 0.26, z score = 16.91, p < 0.0001) to 2010 (Moran's I Index = 0.36, z score = 23.78, p < 0.0001). Clusters of high (Z(G) > 1.96) and low (Z(G) < -1.96) prevalence rates of chronic polypharmacy were found and were not influenced by age. Chronic polypharmacy weakly correlated with hospital admission (2000: ρ = 0.08, p = 0.0032; 2005: ρ = 0.11, p < 0.0001; 2010: ρ = 0.18, p < 0.0001), but not with mortality. CONCLUSIONS: There were geographical differences in the prevalence of older people with chronic polypharmacy that were only partly explained by health indicators. Targeted activities on prescription practice to ensure that the prescribing of chronic polypharmacy is appropriate are required.