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NCT Number: NCT07764822

Eye Tracking and Autism 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.

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Key information

Conditions

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

Age range

14 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location contact

Hannah Rykovich, RN

CONTACT

[email protected]

317-274-4708

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eye-tracking Device

Device

Eye-tracking device for autism detection

Other names: Tobii Eye-Tracker 5L

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Caregiver attitudes towards use of the eye-tracking device

    Time frame: 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."

  2. Individual and Family Predictors (IFP)

    Time frame: Day 1

    Sociodemographic familial history and medical history information for the infant participant will be collected.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana University Health

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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