NCT07070804

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Autism

Interventions

Type	Name	Description
OTHER	None-placebo	No interventions performed

Timeline

• Start date: 2026-09-01
• Primary completion: 2028-08-30
• Completion: 2028-08-30
• First posted: 2025-07-17
• Last updated: 2025-11-21