WINROP Algorithm Validation for Retinopathy Screening in a Cohort of Premature Infants (WINROP)

February 13, 2023 updated by: Jean-Michel HASCOET, Central Hospital, Nancy, France

WINROP Algorithm Validation for Retinopathy Screening in Premature Infants: a Retrospective Cohort Analysis Over 4 Years

When a child was born too early, it is more likely to develop an alteration of its visual function than in the case of term birth. Significant visual disturbances are found in 3% of children born prematurely, but visual impairment can be very severe, up to the loss of vision in case of retinopathy of prematurity (ROP) in the most immature infants. The introduction of screening surveillance systems, such as WINROP software, might reduce the need for stressful eye examination in low risk neonates. This retrospective study aimed at validating the WINROP algorithm in a cohort of premature infants, born below 32 weeks of gestation, who had systematic eye examination for ROP screening over 4 year period.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

570

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

5 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All infants, born from July 2012 to July 2016, from 24 to 32 weeks gestation had hospitalized in our level III NICU having had eye examination up to 40 weeks post menstrual age.

Description

Inclusion Criteria:

  • All infants born below 32 weeks gestation within the study period
  • At least one eye examination recorded by Retcam

Exclusion Criteria:

  • Any ophthalmic abnormality
  • Any genetic abnormality

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
algorithm validation
Time Frame: from birth up to 40 weeks post menstrual age
risk of retinopathy occurence
from birth up to 40 weeks post menstrual age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risk factor for retinopathy
Time Frame: from birth up to 40 weeks post menstrual age
standardized perinatal data collection
from birth up to 40 weeks post menstrual age

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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)

July 1, 2012

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSS2016/WINROP-HASCOET/VS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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