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

Recruitingn/aAges 0 Months - 36 MonthsAllIstituto Superiore di Sanità
NCT06915805 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 unc

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

5 sites
IRCCS MEDEA - Associazione La Nostra Famiglia
Como, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Istituto Superiore di Sanità
Rome, Italy
Ospedale Isola Tiberina-Gemelli Isola
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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