Actively Recruiting
BABYNET National Technology-Based Network for Early Detection of Autism Spectrum Disorder and Neurodevelopmental Disorders in At-Risk Infants
Led by Istituto Superiore di Sanità · Updated on 2025-04-08
296
Participants Needed
5
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Autism spectrum disorder ASD is a neurodevelopmental disorder affecting millions worldwide, with early symptoms often appearing in the first 6 to 12 months of life. This study focuses on infants at higher risk for ASD and other neurodevelopmental disorders NDDs, including siblings of children with ASD, preterm infants, and those small for gestational age SGA. It aims to improve early detection through a national surveillance network using both clinical and experimental protocols. The study involves monitoring infants from birth to 36 months using a combination of clinical assessments and advanced experimental methods. This includes tracking developmental milestones in motor skills, vocalizations, social behaviors, EEG activity, and collecting biological samples for genetic, epigenetic, metabolomic, and inflammatory markers. Data are collected at multiple time points and supported by telehealth services to assist health professionals in monitoring and scoring assessments. Participants will undergo structured interviews, physical measurements, developmental evaluations, and biological sample collections at scheduled visits between birth and 36 months. Researchers will analyze these data to identify early risk markers and build predictive models for ASDNDD diagnoses. The study also includes support for healthcare providers through an online platform and telehealth team, aiming to enhance early diagnostic and intervention processes for at-risk infants.
CONDITIONS
Brief Title
Multi-observational Study for the Early Identification of Autism Spectrum Disorder (ASD) and Other Neurodevelopmental Disorders (NDD) in At-risk Populations
Research Team
M
Maria Luisa Scattoni, Ph.D.
P
Patrizio Pezzotti, MSc
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