Multi-observational Study for the Early Identification of Autism Spectrum Disorder (ASD) and Other Neurodevelopmental Disorders (NDD) in At-risk Populations

Launched by ISTITUTO SUPERIORE DI SANITÀ · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on finding ways to identify autism spectrum disorder (ASD) and other neurodevelopmental disorders (NDD) early in infants who are considered at-risk. It’s important because early detection can lead to timely support and interventions that can improve the quality of life for children with these conditions. The study will collect and analyze various types of data from infants aged 0 to 3 years, particularly looking at behaviors and biological markers that may indicate a risk for ASD or NDD. This research aims to create a system that monitors the development of at-risk infants in hospitals, ensuring they receive the specialized care they need.

To participate, infants must fit specific criteria. They may be considered at-risk if they are siblings of children already diagnosed with ASD, are born preterm, or have a low birth weight. Infants born after 37 weeks of pregnancy and weighing at least 5.5 pounds may also be eligible. The study excludes infants with certain serious health issues or those born extremely prematurely. Families involved can expect close monitoring and support, with the goal of improving early diagnosis and intervention strategies for their children. This trial is currently recruiting participants and is part of a broader initiative to enhance care for vulnerable infants across Italy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Low-risk (LR) infants: born after 37 GW and with birth weight \>= 2500 g;
• • High-risk (HR) infants: siblings of children already diagnosed with ASD; SGA: birth weight below the 3rd percentile; Preterm: born between 26+0 and 31+6 GW;
• • Apgar index over 7 at 5th minute.
• Exclusion Criteria:
• • Infants born before 26 GW;
• • Presence of major acquired perinatal brain lesions, severe cardiovascular, organ and system diseases, known genetic syndromes related to ASD, and medical conditions affecting brain development or infant's ability to participate in the study.