ROP Check Database Premature Infant Outcomes

December 17, 2025 updated by: Alaska Blind Child Discovery

ROP Check Premature Infant Outcomes

The goal of this observation of multi-centered care of infants covered by ROP Check cloud-based database is to compare demographic and clinical risk factors to evaluate and improve vision-protecting guidelines.

Study Overview

Status

Completed

Conditions

Detailed Description

Infants from multiple academic and community hospital neonatal intensive care units (NICUs) and their covering ophthalmologists had the serial eye examination and treatment data covered by ROP Check® cloud-based database. ROP Check assists neonatologists to implement guideline scheduling of infants according to the American Academy of Pediatrics (AAP). Outcome included progression to Type 1 retinopathy of prematurity (ROP) and treatment details such as intra-vitreal anti-VEGF injection and peripheral ablative laser. demographic data including birthweight, gestational age, gender, race/ethnicity are analyzed to determine risk factors severe ROP. Blindness-preventing guidelines are reviewed, analyzed and evidence-based updates are proposed.

Study Type

Observational

Enrollment (Actual)

7070

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Children's EYE & Strabismus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

NICU babies eligible for ROP examination

Description

Inclusion Criteria:

  • NICU infants

Exclusion Criteria:

  • Term birth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROP treatment: After examination, whether an infant reaching criteria for treatment and what treatment was given. Document the number and the proportion needing treatment.
Time Frame: 2010 through 2022
Type 1 ROP
2010 through 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaska Blind Child Discovery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 23, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROPCHECK24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Interest level of other parties

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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