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Improve Screening Criteria for Retinopathy of Prematurity in Two French Center

Evaluation of the Criteria and Modalities of Screening for Retinopathy of Prematurity in Two French Tertiary NICU : is a Simplification Possible ?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05152862
Acronym
DEREP3
Enrollment
886
Registered
2021-12-10
Start date
2022-03-21
Completion date
2022-06-16
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

Keywords

birth weight, gestational age, premature, retina, screening

Brief 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.

Detailed description

Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in children worldwide. Despite a stable incidence over the last decades, improvements in neonatal care and survival of extremely premature lead to an increased screening and follow up of ROP. Retinal examination is painful and can result in clinical deterioration, it also generates significant health care costs. In this way, several studies suggest the need to optimize screening without ignoring severe ROP requiring treatment. Recently, SCREENROP in Canada and SWEDROP studies in Sweden contributed to a modification of the national screening guidelines with a reducing upper limit at 30 weeks of gestational age (GA) and a postponing of the first examination. Because of the population studied, those recommendations cannot be applicable in other countries. Recommendations in France are to screen infants \< 31 GA or 1250 g, first examination should be performed at PMA 31 in infants \< 27 GA and at 4 weeks postnatal age (PNA) in infants born at 27 GA or more. Our main hypothesis is that a reduction of the screening criteria by decreasing the upper limit of the threshold at 30 GA and/or postponing the first examination is acceptable in a population of premature newborns from two French tertiary NICU. This simplification of the screening modalities could reduced the number of fundus examinations performed, while limiting risks for the patient as well as costs. This study could be a pilot study for a national multicenter trial, with the objective of revising national screening guidelines.

Interventions

PROCEDURELaser

Retinal laser photocoagulation

PROCEDUREAnti VEGF

Anti-VEGF intravitreous injection

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 31 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of infants with type 1 or 2 ROP found at routine screening.Day 0Number

Secondary

MeasureTime frameDescription
Time from first retinal examination to treatment of ROPDay 0days
Postnatal age / SAC at first by gestational ageDay 0days
Time from first retinal examination to diagnostic of severe ROPDay 0days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026