Actively Recruiting
Platform for the Prospective Mother-child Study of the Determinants of Autism Spectrum Disorder and Neurodevelopmental Disorders
Led by University Hospital, Montpellier · Updated on 2025-01-16
6300
Participants Needed
1
Research Sites
567 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
U
University Hospital, Lille
Collaborating Sponsor
AI-Summary
What this Trial Is About
Neurodevelopmental disorders such as attention deficit disorder, autism spectrum disorder (ASD), language and social communication disorders, motor coordination disorders, learning disorders, and intellectual development disorders affect many children and impact daily functioning at school and home. These disorders have increased significantly over the past 20 years, with genetic predisposition and environmental exposures during pregnancy possibly playing important roles. Current diagnostic methods rarely allow early identification of babies at risk, limiting timely intervention opportunities. This research follows two groups of families: 1200 high-risk families with an older child diagnosed with ASD and 500 low-risk families without known ASD or neurodevelopmental disorders. The study starts in the second trimester of pregnancy and continues until the children reach 6 years old, when neurodevelopmental disorders can be diagnosed. Parents complete online questionnaires about medical, developmental, lifestyle, nutritional, environmental, and social factors. Biological samples such as urine, hair, nails, blood, and placenta will be collected for future analysis. Children in the high-risk group have developmental assessments at multiple ages up to 72 months, while low-risk children are assessed at 72 months. Participants will be evaluated through clinical observations, questionnaires, and biological sample collection throughout pregnancy and early childhood. Researchers will monitor diagnoses of ASD and other neurodevelopmental disorders, along with socioeconomic, lifestyle, maternal diet, medication use, and environmental exposures. The study aims to understand risk factors and outcomes, improve early detection, and guide care pathways for ASD and related disorders. Total participants include mothers, fathers, unborn children, and siblings, reaching approximately 6300 individuals in the study.
CONDITIONS
Official Title
Platform for the Prospective Mother-child Study of the Determinants of Neurodevelopmental Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be pregnant (single or multiple pregnancy), at least 16 weeks of amenorrhea
- Have at least one biological child of 24 months or older
- Be at least 18 years of age (mother)
- Be the biological father of the unborn child
- Be at least 18 years of age (father)
- Have a woman study participant as mother (unborn child)
- For the high-risk cohort, have a sibling aged between 24 months and less than 18 years with a confirmed diagnosis of Autism Spectrum Disorder
- In cases of multiple ASD siblings, only the last born is included
- ASD siblings from medically assisted procreation are eligible if sharing genetic heritage with the mother or father of the unborn child
You will not qualify if you...
- Unable to understand French or the study questionnaires
- Under legal protective measures or deprived of liberty
- Not affiliated with a social security system
- Refusal to participate or lack of parental authority consent
- Living too far from recruitment center for follow-up
- For the low-risk cohort, having a biological child diagnosed with Autism Spectrum Disorder or another neurodevelopmental disorder
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU Montpellier
Montpellier, France, 34 090
Actively Recruiting
Research Team
A
Amaria Baghdadli, MD PhD
M
Marie Christine Picot, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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