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Completed

NCT Number: NCT03347799

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

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

24 week–40 week

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. algorithm validation

    Time frame: from birth up to 40 weeks post menstrual age

    risk of retinopathy occurence

Secondary outcomes

  1. risk factor for retinopathy

    Time frame: from birth up to 40 weeks post menstrual age

    standardized perinatal data collection

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: WINROP

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Nov 20, 2017
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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