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

Abstract

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

The national, longitudinal NASCITA birth cohort study: prevalence of overweight or obesity at 12 months of age in children born healthy

“…The sample was representative of the national population for distribution by geographical area of residence and environment (rural/urban), and demographic characteristics of the families. [11,12] The anthropometric measures were collected by the paediatricians during the visits and, from this point of view, may be more accurate than when recorded by parents.…”

“…The methods of the NASCITA cohort have been described elsewhere. [11,12] Briefly, Italian health care is provided free or at a minimal charge. All Italian children receive primary health care exclusively from a family paediatrician until they are at least six years old as part of universalistic health system organization.…”

“…Some information was obtained for the NASCITA study in addition to the data routinely collected by the paediatricians during the well-child visits. [11,12]…”

“…Some information was obtained for the NASCITA study in addition to the data routinely collected by the paediatricians during the well-child visits. [11,12] During the first visit, paediatricians collected sociodemographic data regarding the parents, and information about their health status (e.g. smoking habits, chronic diseases), the pregnancy and the delivery.…”

National, longitudinal NASCITA birth cohort study to investigate the health of Italian children and potential influencing factors

“…A total of 139 paediatricians from throughout Italy, representing all geographic areas of the country, agreed to participate. 40 Enrolment took place between April 2019 and July 2020 and, within this time frame, each paediatrician enrolled, for a 1-year period, all newborns presenting for their first visit (which routinely takes place in the first 45 days of life in Italy) and whose parents gave informed consent. No other inclusion or exclusion criteria were present for enrolment.…”