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

Completed

• Conditions: Retinopathy of Prematurity

• Registration Number: NCT03347799
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-01
• Primary Completion: 2016-07-01
• Study Completion: 2017-09-01
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 570

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
risk factor for retinopathy	from birth up to 40 weeks post menstrual age	standardized perinatal data collection