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

NCT07070804 | Not Yet Recruiting

• 1 other identifier: nuMoM2bAutism
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism

Keywords

nuMoM2b; autism; prediction

Outcome Measures

Primary Outcomes (1)

• Diagnosis of autims

  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.

  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.

Interventions

None-placebo OTHER

No interventions performed

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

children of nuMoM2b cohort

You may qualify if:

• child of nuMoM2b study participant

You may not qualify if:

• no biological samples collected during pregnancy

Sponsors & Collaborators

• Indiana University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine for future use

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 17, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study completion