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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03347799

Acronym

WINROP

Enrollment

570

Registered

2017-11-20

Start date

2012-07-01

Completion date

2017-09-01

Last updated

2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

Keywords

very premature infants, screening, retinopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

24 Weeks to 40 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
algorithm validation	from birth up to 40 weeks post menstrual age	risk of retinopathy occurence

Secondary

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

Outcome results