Actively Recruiting
Platform for the Prospective Mother-child Study of the Determinants of 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 with or without hyperactivity, autism spectrum disorder, language and social communication disorder, motor coordination disorder, learning disorder (dyslexia, dyscalculia, dysorthography), intellectual development disorder are frequent and long-lasting developmental difficulties that can be observed in children in various domains. They are often associated and have a significant impact on daily functioning at school and at home. The rate of people affected by neurodevelopmental disorders including autism spectrum disorder have increased significantly over the past 20 years. Improved screening only partly explains this evolution. A genetic predisposition plays an important role in the occurrence of these disorders, however, current scientific data suggest a multifactorial origin. Exposures such as those related to the use of pesticides, air pollution or the presence of endocrine disruptors in our diet could be involved in the genesis of neurodevelopmental disorders, particularly during intrauterine life, a period of great vulnerability. The current diagnostic pathways for autism rarely enable the early identification of babies at risk. Without early detection and timely targeted intervention, these children have a poor health outcome and do not reach their full potential. The general objective of the MARIANNE cohort is to constitute a French research infrastructure dedicated to research on the biological and environmental determinants of neurodevelopmental disorders including autism. This cohort is based on the follow-up of 1200 families with already a child affected by an autism spectrum disorder, which implies a high risk of neurodevelopmental disorders including autism spectrum disorder for the siblings, and of 500 families from the general population with no excess risk of neurodevelopmental disorders. The total number of subjects to be included (mother, father, unborn child and ASD sibling for the HR group) is thus 6300. The inclusion of these families will be at the beginning of a new pregnancy and the follow-up will be carried out from the second trimester of pregnancy until the children are 6 years old, the age at which the diagnosis of neurodevelopmental disorders is possible. Biological, clinical, social and environmental data will be collected at different stages of the follow-up and will be included into a large database.
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU Montpellier
Montpellier, France, 34 090
Actively Recruiting
Research Team
A
Amaria Baghdadli, MD PhD
CONTACT
M
Marie Christine Picot, MD PhD
CONTACT
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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