AutismNCT07070804
Maternal Biomarkers and Environmental Contributors to Autism Spectrum Disorders in Children of First-time Mothers
An observational study of Autism, run by Indiana University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children of nuMoM2b cohort
Who may be able to join
- child of nuMoM2b study participant
Who cannot join
- no biological samples collected during pregnancy
About this study
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.
Read the 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
- Being tested
- None-placebo
- Keywords
- nuMoM2b, autism, prediction
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None-placeboOther
No interventions performed
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Sep 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Haas, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070804
- Sponsor's protocol ID
- nuMoM2bAutism
- Status last verified
- Nov 2025
- First submitted
- 27 Jun 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: deidentified data upon request per NIH guidance
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Biomarkers and Environmental Contributors to Autism Spectrum Disorders in Children of First-time Mothers
- ClinicalTrials.gov ID
- NCT07070804
- Acronym / sponsor ID
- nuMoM2bAutism
- Conditions
- Autism
- Keywords
- nuMoM2b, autism, prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children of nuMoM2b cohort
Key inclusion criteria (1 listed)
- child of nuMoM2b study participant
Key exclusion criteria (1 listed)
- no biological samples collected during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None-placeboNo interventions performed | Other | – |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Yes. deidentified data upon request per NIH guidance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.