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A new window into Babies' eyes: can advanced imaging improve care for premature infants?

NCT ID NCT06612541

Diagnosis Sponsor: Vanderbilt University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study is testing a new, noninvasive imaging device called HH-SECTR to see inside the eyes of premature infants with retinopathy of prematurity (ROP), a condition that can affect vision. The goal is to see if this technology can provide clearer, more detailed images of the retina than standard exams, helping doctors make better decisions about treatment. The study will include preterm infants born between 24 and 34 weeks of gestation and weighing less than 1500 grams at birth.

What this could mean

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

Active substance
HH-SECTR optical imaging technology
What this could lead to
If successful, this imaging method could help doctors spot and track retinopathy of prematurity more precisely, potentially leading to better and earlier treatment decisions for premature infants.
What could go wrong
This is an early-stage study with a small number of participants. The new imaging technique may not prove more accurate than standard exams, and it may not be feasible in all infants.

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 90 people

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

Started

Feb 2025

Expected to finish

Feb 2030

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

Preterm male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth.

Ages

24 to 34 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 male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth Exclusion Criteria: * Infants surgically treated for ROP * Infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team

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Conditions

The condition(s) this trial relates to.

Premature Birth retinopathy of prematurity

As listed by the trial registrant

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

Retinopathy of prematurity (ROP) Rop examination

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

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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