Finding studies
Finding studies
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Lead
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
The clinical and instrumental variables that will be collected are all those relating to the diagnosis and management of neonatal epileptic seizures and the outcome of psychomotor development. The data will be those collected from the electronic medical record. The videoEEG reports will be completed by the re-evaluation of the original EEG tracing, whenever this data is available. The official ILAE classification of 2017 by Fisher e al. (2017) and the ILAE neonatal adaptation of 2021 by Pressler et al. (2021) will be used for the seizure type classification. The sample size is estimated at 140 subjects, approximately 10 subjects per year. The extimate derives from the calculation of the average annual incidence of newborns born in our center or transferred from other hospitals in the period 2008-2018. Since the etiology of neonatal crises is heterogeneous and there are no preliminary scientific data currently available on the topic, it is not possible to calculate exactly a priori the number of subjects necessary for the results to be significant. The data analysis will be primarily descriptive and epidemiological in order to detect trends in the associations between the variables. Only after this pilot phase will we try, where possible, to apply statistical tests for significance analysis. At this point, to evaluate the associations between categorical variables (such as between the "seizure type" category and the "etiology" category), where possible, the Chi-square or Fisher test will be used and the odds ratio calculation. To evaluate the association between quantitative variables such as the association between length of hospital stay and time of instituting the most effective drug from seizure onset (for each specific etiology), linear regression and Pearson correlation will be used. To evaluate the association between categorical variables (predictors) of the neonatal period (such as type of seizure, etiology, etc.) and developmental outcomes expressed as quantitative measures, the Spearman rank correlation test or MANOVA will be used.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
