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Maternal Risk, Fetal-Neonatal Brain Connectivity, and Early Neurodevelopment: A Longitudinal Observational Study

IRCCS San Raffaele · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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brain-connectivitybrain-developmentcognitive-developmentfunctional-connectivityneurodevelopmentpregnancy
This study aims to understand how a pregnant woman's health, lifestyle, and psychological state-especially when associated with known risk factors-might influence the developing brain of her baby, both before and after birth. Specifically, the research investigates whether differences in brain connectivity observed through fetal and neonatal magnetic resonance imaging (MRI) can predict how a child will develop cognitively, emotionally, and behaviorally from birth through early childhood. This is a prospective, observational study that will follow 160 pregnant women and their children over time. Participants will be enrolled at the Gynecology and Obstetrics Unit of San Raffaele Hospital in Milan. Using advanced brain imaging techniques (resting-state functional MRI), the study will examine how key brain systems-such as those involved in movement, hearing, vision, language, and attention-are connected during fetal life and shortly after birth. The study also evaluates how these patterns of brain connectivity relate to later developmental outcomes, assessed through standard neuropsychological tests from birth up to 6 years of age. One of the study's core hypotheses is that early patterns of brain connectivity-especially when combined with detailed profiles of maternal health and risk-can serve as early markers of a child's neurodevelopmental path. To explore this, the study uses an integrated approach that combines imaging data with clinical and psychological information from the mother (e.g., her stress levels, medical history, and lifestyle habits). Participants are grouped based on the "Maternal Frailty Inventory," a tool that captures the cumulative risk profile of each mother. The sample will include mothers with both low and medium-high risk scores. This grouping allows researchers to investigate how varying degrees of maternal risk are reflected in the baby's early brain organization and how this, in turn, influences developmental milestones. A secondary aim
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