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

NCT06729333 | Not Yet Recruiting

• 1 other identifier: XHEC-C-2024-205-1
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

retinopathy of prematurity; incidence rate; screening

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary hospital

You may qualify if:

• 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.

You may not qualify if:

• Death before the first screening;
• Death or loss to follow-up before complete retinal vascularization;
• Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;
• 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;
• Poor systemic condition preventing fundus examination;
• History of ocular trauma or surgery (excluding treatments for ROP);
• Poor-quality fundus images;

Sponsors & Collaborators

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

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

Location

MeSH Terms

Conditions

Premature Birth; Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ping Fei, MD

CONTACT

86+15000672472; shirleypingfei@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Ophthalmology

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 11, 2024
• Study Start: December 15, 2024
• Primary Completion: December 14, 2025
• Study Completion (Estimated): June 14, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

CN (1)