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Can smarter screening save premature Babies' sight?

NCT ID NCT06729333

Knowledge-focused Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 31, 2026 · Last updated Jul 31, 2026

Summary

This study is looking at thousands of premature and low-birth-weight babies in China to understand how common retinopathy of prematurity (ROP) is today. ROP is an eye condition that can lead to blindness if not caught early. The researchers want to find out the best time and criteria for screening, so that babies who need treatment are identified sooner, while avoiding unnecessary tests for those at lower risk.

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 could lead to more accurate and cost-effective screening guidelines for retinopathy of prematurity in China, potentially preventing blindness in preterm infants.
What could go wrong
The study is observational and does not test a treatment. Its findings depend on the participating hospitals and may not apply to all regions or healthcare 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.

Participants

4,841 people

The number who actually took part.

Started

Dec 2024

Finished

May 2026

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

Tertiary hospital

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: From December 2024 to May 2025, preterm infants (gestational age \<37 weeks) or low birth weight infants (birth weight \<2500 g) who receive their first ROP screening at Xinhua Hospital or partner institutions will be included. Exclusion Criteria: 1. Death before the first screening; 2. Death or loss to follow-up before complete retinal vascularization; 3. Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease; 4. Coexisting conditions affecting the classification or staging of ROP, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, Terson syndrome, or other ocular infections or diseases; 5. Poor systemic condition preventing fundus examination; 6. History of ocular trauma or surgery (excluding treatments for ROP); 7. Poor-quality fundus images; 8. Other conditions deemed exclusionary by the investigators.

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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.

Low birthweight infant Premature birth of newborn Retinopathy of prematurity (ROP)

Contacts and locations

Locations

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092, China

More trials for these conditions

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