Eye Tracking and Autism in Former Preterm Infants

NCT07764822 | Not Yet Recruiting FDA Device

• 1 other identifier: 31847
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Prematurity

Keywords

autism; prematurity; eye tracking biomarkers

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1

• Number of participants with suspected autism

  The number of participants whose eye-tracker data suggest a potential autism diagnosis will be totaled.

  Day 1

Secondary Outcomes (2)

• Caregiver attitudes towards use of the eye-tracking device

  Day 1

• Individual and Family Predictors (IFP)

  Day 1

Study Arms (1)

Intervention

EXPERIMENTAL

Eye-tracking device

Device: Eye-tracking device

Interventions

Eye-tracking device DEVICE

Eye-tracking device for autism detection

Also known as: Tobii Eye-Tracker 5L

Intervention

Eligibility Criteria

• Age: 14 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Non-English-speaking participants and families.

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Premature Birth

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Pyone David, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Rebecca McNally Keehn, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Edgardo Szyld, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): January 3, 2028
• Study Completion (Estimated): January 3, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

US (1)