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Completed

NCT Number: NCT06729333

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

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.

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Key information

Conditions

Premature Birth of Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Low Birthweight Infant Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Retinal Diseases Retinopathy of Prematurity Retinopathy of Prematurity (ROP) Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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;
  • Other conditions deemed exclusionary by the investigators.

Treatment and study plan

Primary outcomes

  1. The incidence rate of ROP

    Time frame: 6 months after the first screening

  2. Gestational age at which treatment-requiring ROP develops

    Time frame: 6 months after the first screening

  3. Birthweight at which treatment-requiring ROP develops

    Time frame: 6 months after the first screening

Secondary outcomes

  1. Gestational age of infants developing any ROP lesion

    Time frame: 6 months after the first screening

  2. Birthweight of infants developing any ROP lesion

    Time frame: 6 months after the first screening

  3. Postmenstrual age (PMA) at which ROP lesions occur

    Time frame: 6 months after the first screening

  4. PMA at which treatment-requiring ROP occurs

    Time frame: 6 months after the first screening

  5. Screening and treatment costs

    Time frame: 6 months after the first screening

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Acronym: SChiROP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2024
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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