Early identification of autism and neurodevelopmental disorders in at-risk infants
BABY@NET: A Technology-based National Surveillance Network for the Early Identification of Autism Spectrum Disorder and Other Neurodevelopmental Disorders in At-risk Populations
This study is trying to find early signs of autism and other developmental disorders in babies who are at higher risk so they can get help sooner.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 296 (estimated) |
| Ages | 0 Months to 36 Months |
| Sex | All |
| Sponsor | Istituto Superiore di Sanità Academic / other |
| Locations | 5 sites (Como and 4 other locations) |
| Trial ID | NCT06915805 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the early identification of Autism Spectrum Disorder (ASD) and other neurodevelopmental disorders (NDD) in infants who are at higher risk due to factors such as being siblings of ASD children, being small for gestational age, or being born prematurely. The study aims to identify early clinical signs and potential biomarkers that could facilitate timely diagnosis and intervention. By employing a multidisciplinary approach, the research seeks to improve the quality of life for affected children and their families through early detection and tailored interventions.
Who should consider this trial
Good fit: Ideal candidates for this study include infants who are either siblings of children diagnosed with ASD, those born small for gestational age, or those born prematurely.
Not a fit: Patients who may not benefit from this study include those with major acquired perinatal brain lesions or severe medical conditions affecting brain development.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and intervention for children at risk of ASD and NDDs, significantly improving their developmental outcomes.
How similar studies have performed: Other studies have shown promise in early identification and intervention for ASD and NDDs, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Como and 4 other locations
- IRCCS MEDEA - Associazione La Nostra Famiglia — Como, Italy (Recruiting)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Federico II — Naples, Italy (Recruiting)
- Istituto Superiore di Sanità — Rome, Italy (Active_not_recruiting)
- Ospedale Isola Tiberina-Gemelli Isola — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Luisa Scattoni, Ph.D. — Istituto Superiore di Sanità
- Study coordinator: Maria Luisa Scattoni, Ph.D.
- Email: marialuisa.scattoni@iss.it
- Phone: +39 0649903104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.