Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05681923
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2023-01-03
Brief Title:
Platform for the Prospective Mother-child Study of the Determinants of Neurodevelopmental Disorders
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Platform for the Prospective Mother-child Study of the Determinants of Autism Spectrum Disorder and Neurodevelopmental Disorders Neurodevelopmental Disorders
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MARIANNE
Brief Summary:
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
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
Detailed Description:
Context Various forms of Autism Spectrum Disorder ASD affect 52 million people worldwide ASD is an early-onset life-long and heterogeneous condition believed to arise from combinations of genetic and environmental influences but without specific known causes ASD is also a pervasive syndrome that greatly impacts the functioning of the individual throughout life in multiple domains as well as the family and the broader society Approximately 1 to 2 of the population is affected by an autism spectrum disorder and 10 to 15 if considering all neurodevelopmental disorders NDD They have increased dramatically over the past 20 years in line with improved screening and diagnostic practices However these factors explain only part of the observed increase and have raised questions about the contribution of environmental changes Research has shown that ASD overlaps or co-occurs with other clinical neurodevelopmental disorders NDDs such as attention-deficithyperactivity disorder or intellectual disabilities This raises the question of phenotypic variations or comorbid association between the disorders In addition there is a familial recurrence risk of ASD studies supporting that younger siblings of children with ASD have an 18 increased relative risk of being diagnosed with ASD themselves The current diagnostic pathways for ASD 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
Objectives The MARIANNE platform is a research infrastructure aiming to allow future scientific studies on the early external environmental social and internal genetic drivers of ASD and NDDs as well as on the outcome of children with ASD
The primary objective is to compare exposures and development from birth to 6 years of age in children with ASDNDD and those with normal development in a cohort study whose data will be used to build a large research infrastructure Specific descriptive etiological economic and social objectives are also included
Descriptive Objectives
To identify and clinically characterize cases of ASD and NDD
To describe the clinical course of ASD and NDD cases from birth to age 6 in different dimensions autistic psychiatric and neurodevelopmental symptoms health and development
Describe access to care and the care pathway of ASD and NDD cases use of health services treatments and interventions and the modalities of care specialized interventions schooling childcare
Etiological Objectives
To identify prenatal and perinatal risk factors for ASD and NDD related to the external exposome such as parental health and lifestyle socioeconomic characteristics maternal diet during pregnancy maternal medication use during pregnancy pregnancy and delivery complications clinical social health behaviors and interventions and environmental chemical exposures indoor outdoor and occupational
To study the interactions between exposome and genome risk factors in ASD or NDD
Economic and Social Objectives
Assess the medico-economic impact of ASD and NDD
To study the impact on child health and outcomes of parental mental health access to care and specialized interventions socioeconomic status and education
Methods
Cohort study including two groups of families recruited over the same period in the same maternity hospitals without any other matching criteria
At-risk families 1200 pregnant women over 18 years of age at increased risk of having a child with TSA or NDDs eg because they already have biological child andor a partners biological child with a confirmed ASD ii their partner and iii the future child The women should be able to read and respond to the questionnaires Both parents will agree to their child being monitored and to at least the mother being monitored as well
Control or Low-risk families 500 pregnant women not primiparius single or multiple pregnancies included from the 2nd trimester of pregnancy over the age of 18 years with no biological child over the age of 2 years with a known or suspected diagnosis of ASD or NDD If there are non-biological children in the family such as the fathers children the pregnant women may be included in the study if these children have never been suspected of or had a confirmed ASD or NDD These women should be able to read and respond to the questionnaires Both parents will agree to their child being monitored and to at least the mother being monitored as well
The follow-up will start during the second or third trimesters of pregnancy It will continue at birth and into childhood up until the age of 3 and 6 years when the diagnoses of ASD and other NDDs can be confirmed by clinical multidisciplinary assessment Biospecimens blood urine will be collected from the parents and children and stored in a biobank to allow future assays of exposure and effect biomarkers as well as genotyping The multidimensional questionnaires and examinations will provide a clinical biological and social assessment of the child hisher parents and hisher autistic elder sibling
Based on the estimated number of subjects needed 1200 families will be included in the high-risk cohort which after a 6-year follow-up is expected to identify approximately 200 children with ASD 340 with other ASD and 660 children with normal development
The control cohort will consist of 500 families of which approximately 445 children with normal development 5 with ASD and 50 with other NDD are expected The total number of subjects to be included mother father unborn child and ASD sibling for the HR group is thus 6300
Expected benefits With the recruitment of 1200 families MARIANNE cohort is expected to be one of the largest studies on ASD and NDDs with prenatal recruitment At a societal level the identification of biomarkers will facilitate the diagnosis and medical management of ASD and NDDs Another impact covers scientific advances fostered by a better understanding of the underlying etiopathogenic mechanisms Finally by proposing an evaluation of the care pathways of a large sample of children the MARIANNE platform will contribute to providing useful indicators for the piloting of national policies on access to care and management of ASD and NDDs in France
Objectives The MARIANNE platform is a research infrastructure aiming to allow future scientific studies on the early external environmental social and internal genetic drivers of ASD and NDDs as well as on the outcome of children with ASD
The primary objective is to compare exposures and development from birth to 6 years of age in children with ASDNDD and those with normal development in a cohort study whose data will be used to build a large research infrastructure Specific descriptive etiological economic and social objectives are also included
Descriptive Objectives
To identify and clinically characterize cases of ASD and NDD
To describe the clinical course of ASD and NDD cases from birth to age 6 in different dimensions autistic psychiatric and neurodevelopmental symptoms health and development
Describe access to care and the care pathway of ASD and NDD cases use of health services treatments and interventions and the modalities of care specialized interventions schooling childcare
Etiological Objectives
To identify prenatal and perinatal risk factors for ASD and NDD related to the external exposome such as parental health and lifestyle socioeconomic characteristics maternal diet during pregnancy maternal medication use during pregnancy pregnancy and delivery complications clinical social health behaviors and interventions and environmental chemical exposures indoor outdoor and occupational
To study the interactions between exposome and genome risk factors in ASD or NDD
Economic and Social Objectives
Assess the medico-economic impact of ASD and NDD
To study the impact on child health and outcomes of parental mental health access to care and specialized interventions socioeconomic status and education
Methods
Cohort study including two groups of families recruited over the same period in the same maternity hospitals without any other matching criteria
At-risk families 1200 pregnant women over 18 years of age at increased risk of having a child with TSA or NDDs eg because they already have biological child andor a partners biological child with a confirmed ASD ii their partner and iii the future child The women should be able to read and respond to the questionnaires Both parents will agree to their child being monitored and to at least the mother being monitored as well
Control or Low-risk families 500 pregnant women not primiparius single or multiple pregnancies included from the 2nd trimester of pregnancy over the age of 18 years with no biological child over the age of 2 years with a known or suspected diagnosis of ASD or NDD If there are non-biological children in the family such as the fathers children the pregnant women may be included in the study if these children have never been suspected of or had a confirmed ASD or NDD These women should be able to read and respond to the questionnaires Both parents will agree to their child being monitored and to at least the mother being monitored as well
The follow-up will start during the second or third trimesters of pregnancy It will continue at birth and into childhood up until the age of 3 and 6 years when the diagnoses of ASD and other NDDs can be confirmed by clinical multidisciplinary assessment Biospecimens blood urine will be collected from the parents and children and stored in a biobank to allow future assays of exposure and effect biomarkers as well as genotyping The multidimensional questionnaires and examinations will provide a clinical biological and social assessment of the child hisher parents and hisher autistic elder sibling
Based on the estimated number of subjects needed 1200 families will be included in the high-risk cohort which after a 6-year follow-up is expected to identify approximately 200 children with ASD 340 with other ASD and 660 children with normal development
The control cohort will consist of 500 families of which approximately 445 children with normal development 5 with ASD and 50 with other NDD are expected The total number of subjects to be included mother father unborn child and ASD sibling for the HR group is thus 6300
Expected benefits With the recruitment of 1200 families MARIANNE cohort is expected to be one of the largest studies on ASD and NDDs with prenatal recruitment At a societal level the identification of biomarkers will facilitate the diagnosis and medical management of ASD and NDDs Another impact covers scientific advances fostered by a better understanding of the underlying etiopathogenic mechanisms Finally by proposing an evaluation of the care pathways of a large sample of children the MARIANNE platform will contribute to providing useful indicators for the piloting of national policies on access to care and management of ASD and NDDs in France
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None