- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03347799
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
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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