Maternal Biomarkers and Environmental Contributors to Autism Spectrum Disorders in Children of First-time Mothers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: None-placebo.
- Who it may be relevant to
- Registry conditions: Autism. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will recruit nuMoM2b participants to complete autism screening surveys and will identify 200 children with autism and 400 controls for the study. It will then use existing biospecimens to measure pesticides in maternal urine and metabolomic urine and cord blood predictors of autism risk. All data will then be used to build a predictive model for autism risk at the child's birth.
Detailed description
NuMoM2b participans will be contacted as part of ongoing contacts and will be consented for their offspring to participate. The children will also undergo an Assent process. Screening for autism will occur using standard validated tools and anyone who screens positive will have remote diagnostic testing with trained study staff. The study aims to identify a cohort of 200 children with autism and will then randomly select a group of 400 children typically developing. Predictive models for autism will be constructed using pregnancy and birth data as well as biomarkers from maternal urine and cord blood. We will include metabolomic biomarkers as well as environmental exposures to assess if they improve the predictive model.
Interventions
- Other None-placebo
No interventions performed
Primary outcome measures
- Diagnosis of autims [Time frame: The children are age 11-14 currently. The outcome will be measured during contact with the children in the first 18 months of the project.]
Eligibility criteria
Inclusion criteria
- child of nuMoM2b study participant
Exclusion criteria
- no biological samples collected during pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07070804 · nuMoM2bAutism