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
This trial accepts healthy volunteersQualifiers
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 population
Low risk cohort is a community based sample. High risk cohort is a community based sample as well as an active list of patients followed in specialized department in the management of children with neurodevelopmental disorders. The persons involved in the study are the pregnant woman, her partner (if he is the biological father of the unborn child and lives with the mother), the newborn child, and the older sibling with autism.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaires
Other interventionParents will be asked to complete online self-questionnaires. These questionnaires will provide essential information on medical data, child development, lifestyle habits, nutritional habits, environmental exposures, and family social characteristics.
Biospecimen collection
Other interventionurine, hair, nails, baby tooth, stool, blood, umbilical cord blood, placenta
Neurodevelopmental assessment visit
Other interventionHigh-Risk Cohort : Clinical observations of the unborn child will be performed at 3 months, 6 months, 12 months, between 24 and 30 months, 36 months, and 72 months by psychologists or child psychiatrists in the participating hospitals. They will allow to evaluate the child's behaviors in the areas of communication and social interaction. A video recording of the baby at 3 months of age will allow the analysis of the General Movements Assessment. Low-Risk Cohort : linical observations of the unborn child will be performed at 72 months by psychologists or child psychiatrists in the participating hospitals.
DNA collection
Other interventionIf genetic consultation is provided to the family as part of the routine care, the results will be collected and additional blood samples may be taken.
Treatment groups
7,320 Participants
are divided into 2 treatment groupsGroup A: High-Risk Cohort4 interventions
Group B: Low Risk Cohort3 interventions
Trial outcomes
Primary outcomes
1
Autism Spectrum Disorder diagnosis
ASD diagnosis will be determined by the ADOS-2 (Autism Diagnostic Observation Schedule)
Time frame
between 60 and 66 months2
Autism Spectrum Disorder diagnosis
ASD diagnosis will be determined by the ADOS-2 (Autism Diagnostic Observation
Time frame
between 24 and 30 months3
Developmental Intelligence Disorder diagnosis
Measure of intelligence quotient by scales adapted to the child's age and level of development and developmental level: Weschler, or Mullen scales
Time frame
at 72 months4
Developmental Coordination Disorder diagnosis
Description: the diagnosis will be determined by the DCDQ-FE (Developmental Coordination Disorder Parent Questionnaire Coordination), a 15 items scale, which is the French-European version of the DCDQ-0, Developmental Coordination Disorder Parent Questionnaire Coordination to help identify Developmental Coordination Disorder in children aged 5 to 15 years. The items are grouped into three subdomains: 1) control during movement, 2) fine motor/writing, and 3) global coordination. Each item is rated on a 5-point scale, from 1 ("does not match my child at all") to 5 ("matches my child perfectly")."
Time frame
at 72 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov