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CompletedNCT03347799WINROPUpdated Feb 15, 2023

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

An observational study in Retinopathy of Prematurity, sponsored by Central Hospital, Nancy, France. Completed. Open to participants aged 24 Weeks to 40 Weeks. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by Central Hospital, Nancy, France · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
570
Ages
24 Weeks to 40 Weeks
Sex
All
01

Study 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.

02

Conditions studied

  • Retinopathy of Prematurity

Keywords

  • very premature infants
  • screening
  • retinopathy
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In context

Retinopathy of Prematurity

169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.

This study's enrollment of 570 is above the median of 175 across 57 observational studies indexed under Retinopathy of Prematurity.

Browse Retinopathy of Prematurity studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Weeks to 40 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any ophthalmic abnormality
  • Any genetic abnormality
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
570 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. algorithm validation

    risk of retinopathy occurence

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

Secondary outcomes

  1. risk factor for retinopathy

    standardized perinatal data collection

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2012 to primary completion in Jul 2016, 48 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2017
First posted
Nov 20, 2017
StartActual
Jul 1, 2012
Primary completionActual
Jul 1, 2016
CompletionActual
Sep 1, 2017
Last update
Feb 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03347799
Responsible party
Jean-Michel HASCOET (Professor, Central Hospital, Nancy, France) — Principal investigator
First posted
Nov 20, 2017
Start date
Jul 1, 2012
Primary completion
Jul 1, 2016
Completion
Sep 1, 2017
Last update
Feb 15, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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