NCT07312669

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,070

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

13 years

First QC Date

November 23, 2025

Last Update Submit

December 17, 2025

Conditions

Retinopathy of Prematurity (ROP)

Keywords

gestational age, birthweight, race, gender

Outcome Measures

Primary Outcomes (1)

  • ROP treatment: After examination, whether an infant reaching criteria for treatment and what treatment was given. Document the number and the proportion needing treatment.

    Type 1 ROP

    2010 through 2022

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NICU babies eligible for ROP examination

You may qualify if:

  • NICU infants

You may not qualify if:

  • Term birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Children's EYE & Strabismus

Anchorage, Alaska, 99508, United States

Location

Related Publications (1)

  • 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.

    PMID: 28850643BACKGROUND

MeSH Terms

Conditions

Retinopathy of PrematurityBirth WeightCoitus

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 31, 2025

Study Start

January 1, 2010

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations

US(1)