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Study identifier: NCT06915805 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Autism Spectrum Disorder (ASD) · Neurodevelopmental Disorders  ·  Sponsor: Istituto Superiore di Sanità

PhaseN/A
Planned participants296
Who can joinAll sexes, 0 Months to 36 Months
Healthy volunteersYes

About this study

Autism spectrum disorder (ASD) is a neurodevelopmental disorder (NDD) that affects about 78 million people worldwide. Its prevalence and degree of impact on individuals and families place it among disorders of global importance. ASD resulted in 4.31 million (95% UI 2.82-6.23) global Disability-Adjusted Life Years (DALYs) in 2019, equivalent to 0.2% (0.1-0.2) of DALYs and contributed to 3.4% (2.7-4.3) of DALYs for the aggregate of mental disorders. Evidence shows that early and tailored intervention limits the impact of symptomatology and improves the quality of life of people with ASD and other NDDs and their families. Early identification of clinical signs (red flags) is the first step to facilitating prompt referral for an assessment and diagnosis. In many cases, features of ASD/NDDs manifest early in development (first 6-12 months), although the specificity of these signs is still unclear. Three infants' populations are at higher risk for developing ASD/NDDs compared to the general population: siblings of children diagnosed with ASD (18.7%), preterms, and Small for Gestational Age (SGA). In preterm infants, the prevalence of ASD has been estimated as 7% (95% IC, 4-9) and ADHD is diagnosed twice as often (OR: 1.6; 95% CI: 1.3-1.8). Moreover, the risk for developing ASD in SGA has been estimated as 1.17 (95% CI, 1.09-1.24). Setting up a system to monitor infant neurodevelopmental trajectories through a specific experimental and clinical protocol will enable strategic prevent…

This description comes directly from the study's public registry record.

Talk to the study team

Maria Luisa Scattoni, Ph.D.  ·  +39 0649903104  ·  marialuisa.scattoni@iss.it

Patrizio Pezzotti, MSc  ·  +39 3394438833  ·  patrizio.pezzotti@iss.it

Always discuss trial participation with your own doctor first.

Locations (5)

IRCCS MEDEA - Associazione La Nostra FamigliaComo, ItalyRecruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilan, ItalyRecruiting
Azienda Ospedaliera Universitaria Federico IINaples, ItalyRecruiting
Istituto Superiore di SanitàRome, ItalyActive Not Recruiting
Ospedale Isola Tiberina-Gemelli IsolaRome, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06915805