Eye Tracking and Autism in Former Preterm Infants

NCT07764822 — Not applicable, Not yet recruiting, 40 participants, Indiana University

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Eye-Tracking Biomarkers for Early Autism Detection in Former Preterm Infants

Registry	NCT07764822
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	40 (Estimated)
Sponsor	Indiana University (Other); collaborators: Indiana University Health
Conditions	Autism, Prematurity
Interventions	Eye-tracking device (Device)
Dates	start 2027-01-04 (estimated), primary completion 2028-01-03 (estimated), completion 2028-01-03 (estimated), first posted 2026-08-14, last updated 2026-08-14
Locations	1 site in United States

-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). Eligible participants referred for autism testing through EYP will undergo a traditional comprehensive diagnostic assessment by an EYP clinical psychologist.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention	Experimental	Device: Eye-tracking device	Eye-tracking device

Eye-tracking device (Device), also known as Tobii Eye-Tracker 5L: Eye-tracking device for autism detection

+Outcome measures

Primary outcomes

Number of participants with usable eye-tracking biomarker data [Day 1]: The number of participants from whom usable eye-tracking biomarker data is collected will be totaled.
Number of participants with suspected autism [Day 1]: The number of participants whose eye-tracker data suggest a potential autism diagnosis will be totaled.

Secondary outcomes

Caregiver attitudes towards use of the eye-tracking device [Day 1]: 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."
Individual and Family Predictors (IFP) [Day 1]: Sociodemographic familial history and medical history information for the infant participant will be collected.

+Eligibility

Sex: All, ages: 14 Months to 48 Months

Inclusion Criteria:

* 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)

Exclusion Criteria:

* Non-English-speaking participants and families.

+Locations (1)

Facility	City	Country	Status
Riley Hospital for Children	Indianapolis, Indiana	United States

+Investigators

Pyone David, MD, Principal investigator, Indiana University
Rebecca McNally Keehn, PhD, Principal investigator, Indiana University
Edgardo Szyld, MD, Principal investigator, Indiana University