2-Brain Regulation for Improved Neuroprotection during Early Development (2-BRAINED): a translational hyperscanning research project.

Introduction: Very preterm (VPT) birth is a major risk condition for child development and parental wellbeing, mainly due to multiple sources of stress (e.g., separation and pain exposure) during the neonatal intensive care unit (NICU) stay. Early video-feedback (VF) interventions proved effective in promoting VOT infants' development and parental wellbeing. Electroencephalography (EEG) hyperscanning allows the assessment of brain-to-brain co-regulation during live interaction between infants and parents, offering promising insights into the mechanisms behind the interactive benefits of early VF interventions.

Goals: This study aimed to compare indices of brain-to-brain co-regulation between dyads of full-term (FT) and VPT infants interacting with their mothers and investigate the effect of an early post-discharge VF intervention on the brain-to-brain co-regulation indices of VPT dyads.

Methods And Analysis: VPT and FT dyads will be enrolled at birth, and the former will be randomly allocated to one of two arms: VF intervention or care as usual. Short-term effectiveness will be assessed through ratings of mother-infant interaction videotaped before and after the VF intervention or care as usual. Mothers of VPT and FT infants will report on their mental state, parenting stress and bonding, and infant temperament and sensory profile at 3 and 6 months (corrected age, CA). At 9 months CA, all dyads will participate in a lab-based EEG-hyperscanning paradigm to assess brain-to-brain co-regulation through phase-locking value (PLV) and other explorative indices.

Ethics And Dissemination: This study was funded by the Italian Ministry of Health and received approval by the Ethics Committee of Pavia (Italy) and participating hospitals. Research findings will be reported in scientific publications, presented at international conferences, and disseminated to the general public.

Study Registration Number: GR-2021-12375213 (Italian Ministry of Health registry).