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Eye Tracking and Autism in Former Preterm Infants

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07764822
Enrollment
40
Registered
2026-08-14
Start date
2027-01-04
Completion date
2028-01-03
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Prematurity

Keywords

autism, prematurity, eye tracking biomarkers

Brief 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.

Interventions

Eye-tracking device for autism detection

Sponsors

Indiana University
Lead SponsorOTHER
Indiana University Health
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Months to 48 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with usable eye-tracking biomarker dataDay 1The number of participants from whom usable eye-tracking biomarker data is collected will be totaled.
Number of participants with suspected autismDay 1The number of participants whose eye-tracker data suggest a potential autism diagnosis will be totaled.

Secondary

MeasureTime frameDescription
Caregiver attitudes towards use of the eye-tracking deviceDay 1Caregiver 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 1Sociodemographic familial history and medical history information for the infant participant will be collected.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPyone David, MD

Indiana University

PRINCIPAL_INVESTIGATORRebecca McNally Keehn, PhD

Indiana University

PRINCIPAL_INVESTIGATOREdgardo Szyld, MD

Indiana University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026