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Could a smartphone app help babies see better?

NCT ID NCT07717671

Disease control Sponsor: Università degli Studi di Brescia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study tests a caregiver-led digital program called VIPPSTAR designed to improve vision and brain development in infants at risk of or with visual impairment. The program provides personalized activities integrated into daily routines, supported by remote coaching. Researchers will compare vision and developmental outcomes between infants who receive the digital program plus standard care and those who receive standard care alone.

What this could mean

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

Active substance
a caregiver-mediated digital intervention called VIPPSTAR, delivered via a dedicated platform with remote supervision and e-learning
What this could lead to
If successful, this could provide a scalable, home-based therapy to improve visual and developmental outcomes in infants with or at risk of visual impairment.
What could go wrong
This is an early-stage trial with a relatively small sample, and the digital intervention may not prove more effective than standard care. Results may not generalize to all settings.

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 150 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

1 day to 42 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: Study Sample 1 - Infants at Risk of Visual Impairment * Gestational age ≤32 weeks OR full-term/newborns\>32 weeks of age with neonatal distress (Apgar ≤5 at 10 minutes) * NAVEG score ≥3 * At least one neurological or neuroimaging abnormality: * 3 abnormal signs at ATNAT neurological examination OR Abnormal cranial ultrasound findings OR Abnormal MRI findings Exclusion Criteria: Study Sample 1 - Infants at Risk of Visual Impairment * Epileptic encephalopathy * Parents unable to understand local language Inclusion Criteria: Study Sample 2 - Infants/Toddlers With Visual Impairment * Age ≤42 months * Diagnosis of peripheral or cerebral visual impairment * Moderate or severe visual impairment documented by standardized visual acuity testing Exclusion Criteria: Study Sample 2 - Infants/Toddlers With Visual Impairment * Age \>42 months * Refractory epilepsy or epileptic encephalopathy * Participation in another interventional study within previous 12 months * Parents unable to understand local language

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Conditions

The condition(s) this trial relates to.

cortical blindness neurodevelopmental disorder Premature Birth vision disorder

As listed by the trial registrant

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

Cerebral visual impairment Neurodevelopmental disorders Prematurity Visual impairment

How to take part

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

  1. The places running it

    5 sites in 3 countries. 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

  • ASST Spedali Civili di Brescia

    Brescia, BS, 25123, Italy

  • Centrul Republican de Reabilitare pentru Copii

    Chisinau, MD-2019, Moldova

  • Department of Brain and Behavioral Sciences University of Pavia - Child Neurology and Psychiatry Unit IRCCS Mondino Foundation

    Pavia, BS, Italy

  • Katholieke Universiteit Leuven

    Leuven, 3000, Belgium

  • University of Brescia

    Brescia, BS, 25123, Italy

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