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New study aims to catch hidden vision problems in infants early

NCT ID NCT07275021

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 60 infants at high risk for Cerebral Visual Impairment (CVI), a brain-based vision problem often missed until later childhood. Researchers will collect data from clinical exams, brain scans, and vision tests up to 24 months of age. The goal is to create a model that helps doctors identify CVI earlier, so children can get the support they need sooner.

What this could mean

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

What this could lead to
If successful, this study could lead to a predictive model for early detection of CVI, enabling timely visual rehabilitation and better developmental outcomes for at-risk infants.
What could go wrong
This is an observational study, not a treatment trial. It may not produce a reliable predictive model, and results may not apply to all infants with CVI.

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.

Participants

About 60 people

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

Started

Jul 2025

Expected to finish

Dec 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.

Who is studied

The study population includes preterm and term infants at high risk for cerebral visual impairment due to neurological injury diagnosed in the neonatal period. This includes: * Preterm infants born \<32 weeks gestation with intraventricular hemorrhage or white matter injury * Late preterm (34-36 weeks) and term (37-42 weeks) infants with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia or diagnosed with perinatal stroke Eligible infants are enrolled during their initial hospitalization and followed longitudinally into early childhood to assess visual development, neurodevelopmental outcomes, and early signs of cerebral visual impairment. Parent(s) or legal guardian(s) must be willing and able to provide informed consent.

Ages

31 to 42 weeks

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: * Preterm infants born \< 32 weeks gestational age with any of the following: * Germinal matrix/intraventricular hemorrhage (IVH) * White matter injury (WMI), including periventricular leukomalacia (PVL) * Late preterm infants (born 34-36 weeks gestation) or term infants (born 37-42 weeks gestation) with: * Neonatal encephalopathy treated with therapeutic hypothermia for suspected hypoxic-ischemic encephalopathy (HIE) * Infants diagnosed with perinatal stroke Parent(s) or legal guardian(s) willing and able to provide informed consent Exclusion Criteria: Neonates whose parent(s) or guardian(s) cannot commit to long-term follow-up

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia brain injury cortical blindness perinatal asphyxia periventricular leukomalacia vision disorder

As listed by the trial registrant

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

Late preterm or term (37-42WKS) with neonatal encephalopathy treated with hypothermia for hie Preterm less than 32WKS with ivh, wmi/PVL

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

  • Brigham and Women's Hospital, and Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States