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Introduction: Currently national and international registers can be difficult to search for childhood data and none of them focuses on paediatric trials. Randomised controlled trials are viewed as the most [...]

Unlabelled: The aims of the study were to measure the paediatric, off-label use of drugs in the Italian hospital setting and to reveal areas for priority intervention by investigating the therapeutic indications most involved. Prescriptions given to all children admitted to nine general paediatric hospital wards from December 1998 to February 1999 were analysed. In total, 4265 prescriptions were given to 1461 children, 10 of which were unlicensed and excluded from further analysis. Sixty percent of prescriptions (range between centres: 44-71%) were off-label and concerned 89% of children receiving medications (80-96%). The main drug classes were antibacterials, antiasthmatics and analgesics, and represented 56% of off-label prescriptions. Paracetamol (385 prescriptions) and beclomethasone (339) were the generic substances most often used off-label. The most common off-label categories were dosage/frequency (50% of prescriptions), indication and lack of paediatric licence (7% each). Fifty-four per cent of all indications that led to off-label prescribing involved only respiratory problems, fever, respiratory tract infections and bronchospasm.Conclusions: Despite prescription profile differences among centres, off-label use was high everywhere. Immediate action for more rational drug use is necessary and requires not only regulatory intervention but also a more evidence-based, therapeutic approach. [ABSTRACT FROM AUTHOR]

Abstract Background Treatment and prophylaxis of sepsis in very low birth weight neonates is a matter of concern and research is being undertaken with the aim to give rise to shared approaches based on solid evidence. As part of a European initiative, a survey was set up to describe the use of two drugs in this area. The Italian national practices concerning neonatal sepsis, as well as calls for related guidance, are described. Methods A standardized and previously tested questionnaire was submitted online to all Italian level III NICUs. A 5-point Likert scale was used to analyze attitudinal replies. Categorical variables were compared by χ2 analysis and 2-tailed P-values are reported. Results Data was provided by 38 Italian NICUs (36% of the country’s level III centers), 53% of which have 1–10 cases of bacterial sepsis monthly and 90% a prevalence of Conclusions Common approaches are needed to standardize and update a national drug strategy for the prevention and treatment of sepsis in very low birth weight newborns. This can be achieved through collaborative initiatives aimed at setting up guidelines, based on available data, and multicenter trials to produce new evidence that will address the knowledge gaps.

Presents a letter to the editor regarding an article in the New England Journal of Medicine, "Clinical trial registration: a statement from the International Committee of Medical Journal Editors," by C. De Angelis and colleagues.

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., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

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., (© 2024. The Author(s).)

The rapid spread of the SARS-CoV-2 virus has forced healthcare organizations to change their organization, introducing new ways of working, relating, communicating, and managing to cope with the growing number of hospitalized patients. Starting from the analysis of the narratives of healthcare workers who served in the intensive care units of 10 hospitals in Central and Northern Italy, this contribution intends to highlight elements present during the pandemic period within the investigated structures, which are considered factors that can influence the birth of organizational learning. Specifically, the data collected through interviews and focus groups were analyzed using the framework analysis method of Ritchie and Spencer. The conducted study made it possible to identify and highlight factors related to aspects of communication, relationships, context, and organization that positively influenced the management of the health emergency, favoring the improvement of the structure. It is believed that the identification of these factors by healthcare organizations can represent a valuable opportunity to rethink themselves, thus becoming a source of learning.

Purpose: The NASCITA Study, a national-level, population-based, prospective cohort study, was set up to better understand the early health status of Italian children, comprising their physical, cognitive and psychological development, and how it is affected by social and health determinants, including nurturing care. NASCITA will also assess geographical differences and disparities in healthcare., Participants: Participating family paediatricians from throughout Italy enrolled infants born during the enrolment period (April 2019-July 2020). The 5054 newborns seen by the 139 paediatricians for at least two visits, including the first well-child visit, and for whom parental consent was given, make up the baseline population., Findings to Date: Mothers had a mean age at delivery of 33.0 years and tended to have a high or medium level of education (42.5% university and 41.7% high school degrees) and to be employed (69.7%). One-third (36.1%) took folic acid supplementation appropriately, and 6.5% smoked or consumed alcohol (10.0%) during pregnancy. One-third (31.7%) of deliveries were caesarean deliveries. Concerning the newborns, 5.8% had a low birth weight and 6.2% were born prematurely. The majority (87.7%) slept in the supine position, and 63.6% were exclusively breast fed at 1 month, with a decreasing north to south prevalence (χ 2 t 52; p<0.001). Significant north-south differences were found in all areas, including parental education, behaviours in pregnancy and hospital practices. When compared with national level data, the cohort population's distribution, maternal sociodemographic characteristics and newborn physical characteristics reflect those of the Italian population., Future Plans: Data will continue to be collected during the well-child visits until the children are 6 years old, and multiple health outcomes will be studied, spanning child development and illness, as well as potentially related factors including caregiving routines. The findings will be used to develop specific interventions to improve children's health., Trial Registration Number: NCT03894566., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Knowing the research issues addressed by other cohorts when setting up new cohorts allows researchers to avoid unnecessary duplication of efforts, while permitting collaborations, including data merging data, to better tackle knowledge gaps. This study describes the topics addressed by European birth cohorts, the interaction between these cohort interests and aims, and describes the scientific publications deriving from the cohorts., Methods: A previous study found 66 pregnancy and 45 birth cohorts in Europe. In this study, between August and October 2020, the predominant key areas addressed by the 45 birth cohorts identified in the previous study were evaluated, as were the publications found in PubMed that were associated with the 45 cohorts. A network analysis was performed to show the connections between the 13 key areas identified. A focus on a topic in common between two areas was provided, describing the related publications., Results: A total of 1512 references were found in PubMed (148 publications per cohort). Thirteen predominant key areas were identified, the most common of which was "Environmental" (addressed by 20 cohorts). The Environmental, Genes, and Lifestyle exposure areas were the prevalent topics characterizing the network figure. The Environmental area had the largest number of interactions with the other areas, while the Prematurity area (4 cohorts) the least. The focus provided on smoking led to the comparison of 35 publications from the Environmental group of cohorts and 22 from the Prematurity group, but their objectives did not overlap., Conclusions: The results of this descriptive study show that the environment is a priority research area for cohorts in Europe and that cohorts with different research areas may have study issues in common, but may approach them from different viewpoints. Birth cohorts have wide-ranging aims and it would be almost impossible, and undesirable, to have perfectly overlapping and comparable objectives, but joining efforts would permit maximum use of available resources., (© 2022. The Author(s).)

We show a description of pregnancy cohorts in the European region. Our investigation identified 66 pregnancy cohorts, mostly hosted in Western Central Europe. Among these 66 cohorts, 24 began recruitment before the year 2000, while six cohorts are still enrolling. The most common topics were lifestyle, environment and nutrition with allergies and neurodevelopment being a minority. We observed a pattern of positive correlations between data collected using medical records, structured interviews, and the collection of biological samples. Objectively assessed data were negatively correlated with self-administered questionnaires. Eight cohorts addressed intrauterine exposure, focusing on environmental pollutants such as endocrine-disrupting chemicals. The effects of these compounds on the developing foetus have been studied greatly, but more research on their effects is still needed. Many cohorts investigated genetics through the collection of biological samples from the mothers and children, to improve knowledge on the mother-to-child transmission of genetic information, antibodies, microbiota, etc. Paediatric epidemiology represents an important field of research since preserving healthy lives from conception onwards is the most efficient way to improve population health. According to our report, it seems that this field of research is well developed in Europe, where numerous high profile studies are currently ongoing., Competing Interests: The authors declare no conflict of interest.

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., (©Michele Zanetti, Antonio Clavenna, Chiara Pandolfini, Claudia Pansieri, Maria Grazia Calati, Massimo Cartabia, Daniela Miglio, Maurizio Bonati. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 12.03.2021.)

Many birth cohorts have been carried out. We performed a review of European birth cohorts to see the countries involved, provide a panorama of the current research topics and design, and, more generally, provide input for those creating collaborations and laying out guidelines aimed at unifying cohort methodologies to enable data merging and maximize knowledge acquisition. We searched PubMed and Embase for articles referring to longitudinal, prospective European birth cohorts and searched online cohort inventories. We found references to 111 birth cohorts, 45 of which began enrolment at birth. These cohorts began between 1921 and 2015 and represented 19 countries, with varying sample sizes (236 to 21,000 children). As of 5 January 2020, were still recruiting. The main areas addressed were allergic diseases (14 cohorts) and environmental exposure (f12 cohorts) and most cohorts were publicly funded. Given the large costs of running cohorts and the importance of long follow-up periods in identifying the risk factors for disorders thought to have a perinatal/early life etiology, current cohorts must be designed to answer research questions considering several aspects, from genetic ones to psychological, social, and environmental ones. Furthermore, universally recognized methodological aspects are needed to permit the comparison and merging of cohort data.