NCT06915805 (BABY@NET) is a clinical trial in Autism Spectrum Disorder (ASD), sponsored by Istituto Superiore di Sanità.

Who is sponsoring NCT06915805?

NCT06915805 is sponsored by Istituto Superiore di Sanità.

What condition does NCT06915805 study?

NCT06915805 studies Autism Spectrum Disorder (ASD), Neurodevelopmental Disorders.

Is NCT06915805 still recruiting?

NCT06915805 is currently recruiting now. Last updated 8 April 2025.

Last reviewed 2025-04-08 · How we verify

NCT06915805: BABY@NET

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Last updated 8 April 2025

What this trial tests

trial in Autism Spectrum Disorder (ASD) in 296 participants. Currently enrolling.

Timeline

1 April 2023

Primary endpoint
1 November 2025

1 November 2025

Quick facts

Lead sponsor	Istituto Superiore di Sanità
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	296
Start date	1 April 2023
Primary completion	1 November 2025
Estimated completion	1 November 2025
Sites	5 locations across Italy

Conditions studied

Autism Spectrum Disorder (ASD) — all drugs for Autism Spectrum Disorder (ASD) →
Neurodevelopmental Disorders — all drugs for Neurodevelopmental Disorders →

Sponsor

Istituto Superiore di Sanità — full company profile →

Who can join

Adults 0 Months to 36 Months, any sex, with Autism Spectrum Disorder (ASD) or Neurodevelopmental Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 preventive actions. Early detection of ASD/NDDs requires the mainstreaming of child development monitoring into Child Psychiatry Units (CPUs) and Neonatal Intensive Care Units (NICUs) follow-up programs of at-risk infants. Since 2010, the ISS coordinates the Italian Network for early detection of Autism Spectrum Disorders (NIDA Network), actually involving 45 NICUs and 148 CPUs implicated in the diagnosis and treatment of infants at risk for ASD/NDDs in all Italian Regions. Within the NIDA Network, the ISS implemented a clinical protocol for monitoring at-risk infants for ASD/NDDs in the NICUs follow-up and CPUs. However, the implementation of the protocol in the clinical routine practice requires human resources with specific competences in child psychiatry test scoring and motor/vocal/social behavioral analysis. The BABY@NET project will add to 6-to-36 months well-established clinical NIDA protocol, the experimental data collection and analysis of behavioral and neurophysiological/biological features (vocal, motor, social, EEG, genetic/epigenetic, metabolomic, and secretome), in the first 12 months of age, found altered in ASD/NDDs children. The existing IT platform will be improved for collecting research data, audios/videos, tests and providing the telehealth support to those NICUs and CPUs that suffer from shortage of human resources and competences in testing and video scoring of high risk infants. Through statistical analysis of clinical, behavioral, and neurophysiological/biological endpoints, it is possible to identify early risk signals that can significantly anticipate ASD/NDDs diagnoses in at-risk and general populations. The clinical/experimental protocol combined with the digital infrastructure (e-health) will be implemented in NICUs and CPUs throughout the National Health Service (NHS) ensuring the population of at-risk newborns a specialized assessment, the neurodevelopmental surveillance and activation of personalized prevention interventions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Autism Spectrum Disorder (ASD)

Currently open trials in the same condition.

NCT07421830 — An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism · NA · recruiting
NCT07495761 — Prospective Study to Determine the Prevalence of Signs of Central Sensitization in Adults With ASD Without Intellectual · recruiting
NCT07276750 — Coaching and Leadership in Autism Support Settings · NA · recruiting
NCT07304440 — Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study · Phase 1, PHASE2 · recruiting
NCT07189442 — L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD · NA · recruiting

Other Istituto Superiore di Sanità trials

Trials by the same sponsor.

NCT06416137 — Dementia in Migrants Living in Italy: Promoting a Diversity-sensitive Clinical Approach and Provision of Care · not yet recruiting
NCT05680948 — Extended Follow-Up of the ISS T-003 Trial Volunteers (ISS T-003 EF-UP2020) · completed
NCT05793515 — Mechanisms of Inherited Retinal Dystrophies Using Whole Genome Sequencing and in Vitro and in Vivo Models · completed
NCT05473104 — PEERS® for Italy, a Study on Social Skills Intervention for Adolescents With Autism Spectrum Disorder (ASD). · Phase 2 · completed
NCT04716556 — TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06915805 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Istituto Superiore di Sanità
Last refreshed: 8 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06915805.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing