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

Not yet recruiting

• Conditions: Premature Birth of Newborn; Retinopathy of Prematurity (ROP); Low Birthweight Infant

• Registration Number: NCT06729333
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Study Start: 2024-12-15
• Primary Completion: 2025-12-14
• Study Completion: 2026-06-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence rate of ROP	6 months after the first screening
Gestational age at which treatment-requiring ROP develops	6 months after the first screening
Birthweight at which treatment-requiring ROP develops	6 months after the first screening

Secondary Outcome Measures

Name	Time	Method
Gestational age of infants developing any ROP lesion	6 months after the first screening
Birthweight of infants developing any ROP lesion	6 months after the first screening
Postmenstrual age (PMA) at which ROP lesions occur	6 months after the first screening
PMA at which treatment-requiring ROP occurs	6 months after the first screening
Screening and treatment costs	6 months after the first screening

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China