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

NCT03347799 | Completed

• 1 other identifier: PSS2016/WINROP-HASCOET/VS
• Study Type: observational
• Target: 570
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Retinopathy of Prematurity

Keywords

very premature infants; screening; retinopathy

Outcome Measures

Primary Outcomes (1)

• algorithm validation

  risk of retinopathy occurence

  from birth up to 40 weeks post menstrual age

Secondary Outcomes (1)

• risk factor for retinopathy

  from birth up to 40 weeks post menstrual age

Eligibility Criteria

• Age: 24 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• All infants born below 32 weeks gestation within the study period
• At least one eye examination recorded by Retcam

You may not qualify if:

• Any ophthalmic abnormality
• Any genetic abnormality

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Retinopathy of Prematurity; Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 20, 2017
• Study Start: July 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2017
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share