ROP Check Database Premature Infant Outcomes

NCT ID: NCT07312669

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7070 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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 CheckĀ® 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.

Conditions

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Retinopathy of Prematurity (ROP)

Keywords

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gestational age, birthweight, race, gender

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* NICU infants

Exclusion Criteria

* Term birth
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alaska Blind Child Discovery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alaska Children's EYE & Strabismus

Anchorage, Alaska, United States

Site Status

Countries

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United States

References

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Arnold RW, Jacob J, Matrix Z. Toward Achieving 100% Adherence for Retinopathy of Prematurity Screening Guidelines. J Pediatr Ophthalmol Strabismus. 2017 Nov 1;54(6):356-362. doi: 10.3928/01913913-20170329-04. Epub 2017 Aug 29.

Reference Type BACKGROUND
PMID: 28850643 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: ROP Study protocol with Statistical Analysis Plan

View Document

Other Identifiers

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ROPCHECK24

Identifier Type: -

Identifier Source: org_study_id