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NCT03347799 Clinical Trial

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

Retinopathy of Prematurity Clinical Trial

— WINROP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03347799
Other study ID # PSS2016/WINROP-HASCOET/VS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2012
Est. completion date September 1, 2017

Study information
Verified date February 2023
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 570
Est. completion date September 1, 2017
Est. primary completion date July 1, 2016
Accepts healthy volunteers No
Gender All
Age group 24 Weeks to 40 Weeks
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary algorithm validation risk of retinopathy occurence from birth up to 40 weeks post menstrual age
Secondary risk factor for retinopathy standardized perinatal data collection from birth up to 40 weeks post menstrual age
See also
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