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Maternal Biomarkers and Environmental Contributors to Autism Spectrum Disorders in Children of First-time Mothers

Maternal Biomarkers and Environmental Contributors to Autism Spectrum Disorders in Children of First-time Mothers

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07070804
Enrollment
600
Registered
2025-07-17
Start date
2026-09-01
Completion date
2028-08-30
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Keywords

nuMoM2b, autism, prediction

Brief summary

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

No interventions performed

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* child of nuMoM2b study participant

Exclusion criteria

* no biological samples collected during pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of autimsThe children are age 11-14 currently. The outcome will be measured during contact with the children in the first 18 months of the project.Autism diagnoses will be made using the Autism Diagnostic Inventory on all children who screen positive. Alternatively, if already diagnosed clinically, we will request the diagnostic tool used previously for the child.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026