160
Participants
Start Date
July 31, 2025
Primary Completion Date
November 30, 2031
Study Completion Date
January 31, 2033
Maternal Frailty Inventory (MaFra) Questionnaire
A validated psychometric inventory designed to assess maternal clinical, psychological, and lifestyle risk factors during pregnancy. The composite risk score is used to stratify participants into low- or medium/high-risk categories. Administered during pregnancy, the inventory informs classification and predictive modeling of fetal and child neurodevelopmental outcomes.
Fetal Resting-State Functional MRI
Non-invasive resting-state functional MRI scans performed during gestation (fetal) life to assess functional connectivity across sensorimotor, auditory, visual, language, and attention networks. Imaging data are analyzed to derive local and global connectivity measures and indices of segregation and integration among functional brain systems. Structural MRI is used to confirm normal brain morphology.
Maternal Emotional Reactivity
During fetal rs-fMRI acquisition, mothers listen to emotionally evocative musical excerpts while rating their emotional responses. These self-reported ratings (valence and arousal) are later correlated with fetal brain connectivity responses.
Neonatal Resting-State Functional MRI
Non-invasive MRI scanning protocol conducted during the neonatal period to acquire resting-state functional MRI (rs-fMRI) data. The scan is performed while the newborn is in a natural sleep state, using motion-optimized sequences to assess functional connectivity between brain regions. The focus is on sensorimotor, auditory, visual, language, and attention networks. Structural MRI is also acquired to verify normative brain morphology. Imaging outcomes are used in longitudinal analyses to link early brain connectivity with cognitive and behavioral development.
Longitudinal Neurodevelopmental Testing Battery
Standardized neuropsychological and behavioral assessments are administered at multiple timepoints between birth and 72 months of age. Domains evaluated include sensorimotor skills, cognitive abilities, language development, executive function, social-emotional regulation, and adaptive behaviors. Data are used to compute specific and composite scores that reflect neurocognitive and behavioral profiles. These are later integrated with prenatal and neonatal brain imaging and maternal risk data to model individual neurodevelopmental trajectories.
Neuroradiology Unit and CERMAC, IRCCS Ospedale San Raffaele, Milan
IRCCS San Raffaele
OTHER