A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China (SChiROP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Birth of Newborn; Retinopathy of Prematurity (ROP); Low Birthweight Infant

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Ping Fei, MD; Phone Number: 86+15000672472; Email: shirleypingfei@126.com

Study Locations

• China
  • Shanghai, China, 200092
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Contact: Ping Fei, MD; Phone Number: 86+15000672472; Email: shirleypingfei@126.com
    • Contact: Peiquan Zhao, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Tertiary hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): December 14, 2025
• Study Completion (Estimated): June 14, 2026

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: retinopathy of prematurity; screening; incidence rate
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Body Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Infant, Premature, Diseases; Infant, Newborn, Diseases; Eye Diseases; Premature Birth; Birth Weight; Retinal Diseases; Retinopathy of Prematurity
• Other Study ID Numbers: XHEC-C-2024-205-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No