CompletedNot Applicable

Improve Screening Criteria for Retinopathy of Prematurity in Two French Center

France886 participantsStarted 2022-03-21

Plain-language summary

The aim of the study is to assess whether a delay of the first examination can be safely considered in French population. Secondary objectives are to describe retinopathy of prematurity (ROP) in a population of premature from two French tertiary NICU and to identify co-morbidities associated with the development of severe ROP.

Who can participate

Age range

0 Years – 31 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infant with gestational age \< 31 weeks and/or birth weight \< 1250 g * With at least one retinal examination * holders of the parental rights informed and not objecting to the study Exclusion Criteria: * infants died before 28 days PNA * infants with hydrocephaly. * infants with significant congenital malformations or genetic abnormalities.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of infants with type 1 or 2 ROP found at routine screening.

Timeframe: Day 0

Trial details

NCT IDNCT05152862

SponsorCentre Hospitalier Sud Francilien

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-16

View on ClinicalTrials.gov More Retinopathy of Prematurity trials