Status:
RECRUITING
Multi-observational Study for the Early Identification of Autism Spectrum Disorder (ASD) and Other Neurodevelopmental Disorders (NDD) in At-risk Populations
Lead Sponsor:
Istituto Superiore di Sanità
Collaborating Sponsors:
Associazione La Nostra Famiglia, Como, Italy
Federico II University
Conditions:
Autism Spectrum Disorder (ASD)
Neurodevelopmental Disorders
Eligibility:
All Genders
Up to 36 years
Brief Summary
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 dis...
Detailed Description
Background: The global prevalence of ASD has shown a marked increase in the last decades, with a median prevalence of 65/10,000. In Italy, a recent study of the National ASD Observatory estimated a pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT06915805
Start Date
April 1 2023
End Date
November 1 2025
Last Update
April 8 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS MEDEA - Associazione La Nostra Famiglia
Como, Italy, 22037
2
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
3
Azienda Ospedaliera Universitaria Federico II
Naples, Italy, 80131
4
Istituto Superiore di Sanità
Rome, Italy, 00161