BABY@NET: A Technology-based National Surveillance Network for the Early Identification of Autism Spectrum Disorder and Other Neurodevelopmental Disorders in At-risk Populations

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Italy
IRCCS MEDEA - Associazione La Nostra Famiglia
RECRUITING
Como
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Naples
Istituto Superiore di Sanità
ACTIVE_NOT_RECRUITING
Rome
Ospedale Isola Tiberina-Gemelli Isola
RECRUITING
Rome
Contact Information
Primary
Maria Luisa Scattoni, Ph.D.
marialuisa.scattoni@iss.it
+39 0649903104
Backup
Patrizio Pezzotti, MSc
patrizio.pezzotti@iss.it
+39 3394438833
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 296
Treatments
Siblings of children diagnosed with ASD
The sibling population has a 10-fold higher risk than the general population of developing ASD.
Preterms
Infants of preterm birth (born between 26 and 31 gestational weeks) are considered at heightened risk for ASD/NDDs than the general population.
Small for Gestational Age (SGA)
SGA (weight below the 3rd percentile) are considered at heightened risk for ASD/NDDs than the general population.
Low-risk (LR) infants
LR infants are at term and appropriate for gestational age infants.
Sponsors
Collaborators: Federico II University, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Associazione La Nostra Famiglia, Como, Italy
Leads: Istituto Superiore di Sanità

This content was sourced from clinicaltrials.gov