Retinopathy of PrematurityWINROPNCT03347799
WINROP Algorithm Validation for Retinopathy Screening in a Cohort of Premature Infants
An observational study of Retinopathy of Prematurity, run by Central Hospital, Nancy, France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 24 to 40 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- How many people
- 570 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2012to 1 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 40 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- All infants born below 32 weeks gestation within the study period
- At least one eye examination recorded by Retcam
Who cannot join
- Any ophthalmic abnormality
- Any genetic abnormality
About this study
Official title: WINROP Algorithm Validation for Retinopathy Screening in Premature Infants: a Retrospective Cohort Analysis Over 4 Years
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
- Medical subject headings
- Retinopathy of Prematurity, Retinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
algorithm validation
risk of retinopathy occurence
Measured: from birth up to 40 weeks post menstrual age
Secondary outcomes (1)
risk factor for retinopathy
standardized perinatal data collection
Measured: from birth up to 40 weeks post menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Jul 2012
- Primary completion1 Jul 2016
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347799
- Sponsor's protocol ID
- PSS2016/WINROP-HASCOET/VS
- Acronym
- WINROP
- Status last verified
- Feb 2023
- First submitted
- 16 Nov 2017
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WINROP Algorithm Validation for Retinopathy Screening in Premature Infants: a Retrospective Cohort Analysis Over 4 Years
- ClinicalTrials.gov ID
- NCT03347799
- Acronym / sponsor ID
- WINROP / PSS2016/WINROP-HASCOET/VS
- Conditions
- Retinopathy of Prematurity
- Keywords
- very premature infants, screening, retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- All infants born below 32 weeks gestation within the study period
- At least one eye examination recorded by Retcam
Key exclusion criteria (2 listed)
- Any ophthalmic abnormality
- Any genetic abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
algorithm validation
Time frame: from birth up to 40 weeks post menstrual age
risk of retinopathy occurence
1 secondary outcome
risk factor for retinopathy
Time frame: from birth up to 40 weeks post menstrual age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
algorithm validation (time frame: from birth up to 40 weeks post menstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.