Could pregnancy exposures shape neurodevelopment? massive study aims to find out
NCT ID NCT05681923
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 1,200 families who already have a child with autism (high-risk group) and 500 families from the general population (low-risk group) starting from early pregnancy. Researchers collect biological samples and survey data to explore how genetics, environment, diet, and lifestyle may influence the development of autism and other neurodevelopmental disorders. Children are monitored until age 6, when diagnoses can be reliably made.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this research could identify early risk factors and pave the way for earlier detection and intervention for autism and related conditions.
- What could go wrong
- This is an observational study, not a treatment trial. It may take years to yield actionable insights, and findings may not apply to all populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 7,320 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Mar 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA: General inclusion criteria (High risk and Low risk cohorts) Mother: * 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 Father: * Be the biological father of the unborn child, * At least 18 years of age Unborn Child: \- Have a woman study participant as mother. Specific inclusion criteria for the High risk cohort: * Autistic sibling: refers to the biological child(ren) of the mother and/or father participating in the study and being the parent(s) of the unborn child * Be at least 24 months old and less than 18 years old, * Have a confirmed diagnosis of Autism Spectrum Disorder based on medical records. If in doubt, the SRS-2 (Social Responsiveness Scale for Adults) and PEDS-DM (Parents' Evaluation of developmental status) questionnaires will be completed. Only children with positive scores on one of these questionnaires will be included after validation of the diagnosis by an expert committee, * In case of several children with Autism Spectrum Disorder based in the siblings, only the last born will be included. Remarks: * Autism Spectrum Disorder siblings resulting from a medically assisted procreation are eligible provided that part of the genetic heritage is common to that of the mother or father of the unborn child participating in the study. * If the father does not live with the mother of the unborn child, his participation is not required and does not preclude the participation of other family members. EXCLUSION CRITERIA: General non-inclusion criteria (High risk and Low risk cohorts): Father and mother: * 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. * Live at a distance from the recruitment center incompatible with follow-up. Specific non-inclusion criteria for the Low risk cohort: Mother and/or father of unborn child: \- Have a biological child with a diagnosis of Autism Spectrum Disorder or other neuro developmental disorder
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Montpellier
RECRUITINGMontpellier, 34 090, France
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