Maternal Biomarkers and Environmental Contributors to Aut... | NCT07070804

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

NCT07070804

Sponsor

Indiana University

Status

Not yet recruiting

Last Update Posted

Nov 21, 2025Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Autism

Interventions

None-placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Aug 30, 2028Estimated

Completion Date

Aug 30, 2028Estimated

First Submitted Date

Jun 27, 2025

First Submission Date that Met QC Criteria

Jul 8, 2025

First Posted Date

Jul 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2025

Last Update Posted Date

Nov 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Estimated

Name	Type	Description	Arm Group Labels	Other Names
None-placebo	Other	No interventions performed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

child of nuMoM2b study participant

Exclusion Criteria:

no biological samples collected during pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

children of nuMoM2b cohort

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

deidentified data upon request per NIH guidance

Types

Study Protocol

Time Frame

After study completion

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001321	Autistic Disorder

Ancestor Terms

ID	Term
D000067877	Autism Spectrum Disorder
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided