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Can a camera catch autism signs in preemie toddlers?

NCT ID NCT07764822

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This study tests whether an eye-tracking device can help detect autism in toddlers born prematurely (before 37 weeks). Children aged 14-48 months referred for autism evaluation will use the device, and researchers will see if the eye-tracking data points to autism. The goal is to see if this tool can be a useful addition to the standard diagnostic process.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Eye-tracking device (Tobii Eye-Tracker 5L)
What this could lead to
If successful, this could make autism screening faster and more objective for preterm children, potentially leading to earlier support.
What could go wrong
The study is small and early, so the eye-tracking tool may not prove reliable or may not work for all children. It is not a diagnostic test on its own.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 48 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autism Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism Prematurity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.