JMIR Publications

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 six 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 cohort data at six months.

Methods:

Family pediatricians were contacted for participation in the cohort and began enrolling newborns in April 2019 at their first well-child visit. Information collected involves 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:

After 6 months, there were 160 participating pediatricians, distributed throughout Italy, and 2264 enrolled children, representing 24% of children born in 2018 covered by those same pediatricians. At the second routine visit (programmed in the first 60-90 days of life), 59% of the children were still being exclusively breastfed. Of the mothers who were no longer exclusively breastfeeding, a majority (59%) were giving formula milk and 41% breast and formula milk.

Conclusions:

The NASCITA Cohort is well underway and the current population size will already 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. Clinical Trial: ClinicalTrials.gov NCT03894566