Maternal Risk, Fetal-Neonatal Brain Connectivity, and Early Neurodevelopment: A Longitudinal Observational Study
Launched by IRCCS SAN RAFFAELE · Jul 9, 2025
Trial Information
Current as of July 25, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This single-center, prospective longitudinal observational cohort study-entitled Maternal Risk, Fetal-Neonatal Brain Connectivity, and Early Neurodevelopment (MaMRI-NeUCogI)-is designed to explore the relationship between maternal risk profiles, early-life brain connectivity, and developmental outcomes from birth to early childhood (up to 72 months). The protocol aims to trace the temporal continuity between functional neurodevelopmental markers present in utero or shortly after birth and subsequent cognitive, behavioral, and emotional trajectories during early childhood.
Scientific Ration...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Pregnant women (biologically female) receiving care at the Gynecology and Obstetrics Unit, San Raffaele Hospital, Milan.
- • Age ≥ 18 years at time of enrollment.
- • Singleton pregnancy.
- • Gestational age within the range suitable for fetal MRI acquisition (typically 24-35 weeks gestation).
- • Willing and able to provide written informed consent.
- • Willing to undergo fetal and/or neonatal resting-state fMRI as part of the observational study protocol.
- • Willing to complete maternal questionnaires assessing clinical, lifestyle, and emotional factors (e.g., MaFra Inventory, anxiety scales).
- • Willing to participate in postnatal follow-up assessments of the child, including neurodevelopmental evaluations from birth to 72 months.
- • Fetuses with normal brain morphology confirmed by structural MRI.
- • Fetuses and neonates without signal alterations on structural MRI.
- Exclusion Criteria:
- • Twin or multiple gestation pregnancies.
- • Fetal diagnosis of any major structural or genetic anomaly known to impact neurodevelopment.
- • Evidence of fetal brain parenchymal signal alterations or neurodevelopmental abnormalities as assessed by structural MRI and confirmed by an experienced neuroradiologist.
- • Maternal contraindications to undergoing MRI (e.g., presence of non-MRI-compatible implants or severe claustrophobia).
About Irccs San Raffaele
IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, Mi, Italy
Patients applied
Trial Officials
Andrea Falini, Doctor of Medicine
Study Director
1. Vita-Salute San Raffaele University, Milan, Italy; 2. Neuroradiology Unit and CERMAC, IRCCS Ospedale San Raffaele, Milan, Italy
Pasquale Anthony Della Rosa, PhD - Psychology
Principal Investigator
Neuroradiology Unit and CERMAC, IRCCS Ospedale San Raffaele, Milan, Italy
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported