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A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China

NCT ID: NCT06729333

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-15

Study Completion Date

2026-06-14

Brief Summary

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The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.

Detailed Description

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Conditions

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Premature Birth of Newborn Retinopathy of Prematurity (ROP) Low Birthweight Infant

Keywords

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retinopathy of prematurity incidence rate screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Peiquan Zhao

Director of the Department of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Ping Fei, MD

Role: CONTACT

Phone: 86+15000672472

Email: [email protected]

Facility Contacts

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Ping Fei, MD

Role: primary

Peiquan Zhao, PhD

Role: backup

Other Identifiers

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XHEC-C-2024-205-1

Identifier Type: -

Identifier Source: org_study_id