Platform for the Prospective Mother-child Study of the Determinants of Neurodevelopmental Disorders

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

Qualifiers

Be pregnant (single or multiple pregnancy), at least 16 weeks of amenorrhea,

Have at least one biological child of 24 months or older,

At least 18 years of age

Be the biological father of the unborn child,

Disqualifiers

Unable to understand French or the study questionnaires

Participant on protective measures (guardianship or curatorship) or deprived of liberty by judicial or administrative decision, or subject to a legal protection measure

Not affiliated to a social security system

Refusal to participate. In the case of consent given for the born and unborn child, the consent must be given by the person(s) with parental authority.

Trial design

Treatments tested in this trial

  • Questionnaires
  • Biospecimen collection
  • Neurodevelopmental assessment visit
  • DNA collection

Treatment groups

7,320 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Montpellier

Lead sponsor

University Hospital, Lille

Collaborator

Hospices Civils de Lyon

Collaborator

University Hospital of Saint-Etienne

Collaborator

University Hospital, Rouen

Collaborator

University Hospital, Toulouse

Collaborator

Hôpital le Vinatier

Collaborator