Pilot study on efficacy and safety of video-EEG monitoring to early identify newborns affected by mild hypoxic-ischemic encephalopathy who may benefit from therapeutic hypothermia: correlation between early video-EEG monitoring and 24-months neurodevelopmental outcome in treated and non-treated newborns.

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Other

Population studied

• Age groups:
  • Term newborn infants (0 – 27 days)
  • Children (2 to < 12 years)
• Estimated number of subjects:
  40

Study design details

• Main study objective:
  The main objective of this study is to determine in a cohort of newborns affected by mild hypoxic ischemic encephalopathy, treated or non-treated with therapeutic hypothermia, the correlation between early video-EEG monitoring, performed within 6 hours of birth, and 24-months neurodevelopmental outcome, assessed using the Griffiths III Developmental Scales.
• Outcomes:
  The correlation between early video-EEG monitoring, performed within 6 hours of birth, and 24-months neurodevelopmental outcome, assessed using the Griffiths III Developmental Scales, in a cohort of newborns affected by mild hypoxic ischemic encephalopathy, treated or non-treated with therapeutic hypothermia.
• Data analysis plan:
  The Shapiro-Wilk test will be used to assess the normal distribution of variables and, if they will be asymmetric, the Mann–Whitney's U-test will be applied for comparisons of non-normally distributed continuous and discrete variables. The Chi-square test with Yate’s continuity correction and Fisher’s exact test will be used for the comparisons of categorical variables. Correlations will be checked using the Spearman’s rho correlation coefficient. Kruskal-Wallis and Mann-Whitney U post hoc tests, positive predictive values (PPV) and negative predictive values (NPV) will be analyzed to explore differences between neonatal mild HIE classification and v-EEG classification with developmental score at 24 months using the Griffiths III mental development scales. All statistical analysis will be performed using IBM-SPSS® version 26.0 (IBM Corp. Armonk, NY, USA, 2019). In all analyses, a two-sided p-value < 0.05 will be considered significant.