NCT05152862

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
• Phase: —
• Study type: Observational
• Enrollment: 886 (actual)
• Sponsor: Centre Hospitalier Sud Francilien · Academic / Other
• Sex: All
• Age: 0 Years – 31 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
PROCEDURE	Laser	Retinal laser photocoagulation
PROCEDURE	Anti VEGF	Anti-VEGF intravitreous injection

Timeline

• Start date: 2022-03-21
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2021-12-10
• Last updated: 2024-11-26

Locations

1 site across 1 country: France