AutismNCT07764822
Eye Tracking and Autism in Former Preterm Infants
A study testing Eye-tracking device in people with Autism and Prematurity, run by Indiana University at 1 site in United States.
Trial summary
This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP). Read more about this study
- Who is it for?
- Ages 14 to 48 months
- Conditions the study is for
- Autism, Prematurity
- What is being tested?
- Eye-tracking device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2027to 3 Jan 2028
- Phase
- Interventional
- 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 14 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children born at <37 weeks' gestational age who are 14-48 months old at time of referral
- Ambulatory (i.e., cruising, walking)
- Without significant visual impairment
- Referred for autism testing through EYP (i.e. medium- or high-risk M-CHAT-R/F screening result at 16-22 months corrected age or by referral to Early Years based on caregiver or provider concern for autism)
Who cannot join
- Non-English-speaking participants and families.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
Hannah Rykovich, RN, 317-274-4708, hsrakow@iu.edu
About this study
Official title: Eye-Tracking Biomarkers for Early Autism Detection in Former Preterm Infants
This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP). Eligible participants referred for autism testing through EYP will undergo a traditional comprehensive diagnostic assessment by an EYP clinical psychologist.
- Conditions
- Autism, Prematurity
- Being tested
- Eye-tracking device
- Keywords
- autism, prematurity, eye tracking biomarkers
- Medical subject headings
- Autistic Disorder, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-tracking deviceDevice
Also called Tobii Eye-Tracker 5L
Eye-tracking device for autism detection
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Eye-tracking device Receives: Device: Eye-tracking device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with usable eye-tracking biomarker data
The number of participants from whom usable eye-tracking biomarker data is collected will be totaled.
Measured: Day 1
Number of participants with suspected autism
The number of participants whose eye-tracker data suggest a potential autism diagnosis will be totaled.
Measured: Day 1
Secondary outcomes (2)
Caregiver attitudes towards use of the eye-tracking device
Caregiver attitudes will be measured toward healthcare devices form. Caregivers will rate their openness to the use of devices or computer programs in medical care and how important the details of using these devices are to them. Participants will respond to questions on a 5 point Likert scale from "Not Important" to "Extremely Important."
Measured: Day 1
Individual and Family Predictors (IFP)
Sociodemographic familial history and medical history information for the infant participant will be collected.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start4 Jan 2027 (estimated)
- Primary completion3 Jan 2028 (estimated)
- Study completion3 Jan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health
- Responsible party
- Principal investigator, Pyone David, Indiana University
- Investigators
- Pyone David, MD, Principal investigator, Indiana UniversityRebecca McNally Keehn, PhD, Principal investigator, Indiana UniversityEdgardo Szyld, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764822
- Sponsor's protocol ID
- 31847
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye-Tracking Biomarkers for Early Autism Detection in Former Preterm Infants
- ClinicalTrials.gov ID
- NCT07764822
- Acronym / sponsor ID
- 31847
- Conditions
- Autism, Prematurity
- Keywords
- autism, prematurity, eye tracking biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 3 Jan 2028 (estimated)
- Study completion
- 3 Jan 2028 (estimated)
- First posted
- 14 Aug 2026 (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 is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP). Eligible participants referred for autism testing through EYP will undergo a traditional comprehensive diagnostic assessment by an EYP clinical psychologist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Eye-tracking deviceEye-tracking device |
Who may qualify
- Ages
- 14 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children born at <37 weeks' gestational age who are 14-48 months old at time of referral
- Ambulatory (i.e., cruising, walking)
- Without significant visual impairment
- Referred for autism testing through EYP (i.e. medium- or high-risk M-CHAT-R/F screening result at 16-22 months corrected age or by referral to Early Years based on caregiver or provider concern for autism)
Key exclusion criteria (1 listed)
- Non-English-speaking participants and families.
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 |
|---|---|---|
| Eye-tracking deviceAlso: Tobii Eye-Tracker 5LEye-tracking device for autism detection | Device | Intervention |
Primary outcome
Number of participants with usable eye-tracking biomarker data
Time frame: Day 1
The number of participants from whom usable eye-tracking biomarker data is collected will be totaled.
Number of participants with suspected autism
Time frame: Day 1
The number of participants whose eye-tracker data suggest a potential autism diagnosis will be totaled.
2 secondary outcomes
Caregiver attitudes towards use of the eye-tracking device
Time frame: Day 1
Individual and Family Predictors (IFP)
Time frame: Day 1
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 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Pyone David, MD principal investigator
Indiana University
Rebecca McNally Keehn, PhD principal investigator
Indiana University
Edgardo Szyld, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye-tracking device in people with Autism and Prematurity, run by Indiana University at 1 site in United States.
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 4 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with usable eye-tracking biomarker data (time frame: Day 1). The study lists 2 primary outcomes in all. 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 14 Aug 2026.