Improve Screening Criteria for Retinopathy of Prematurity in Two French Center

NCT ID: NCT05152862

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 886 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2022-06-16

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.

Conditions

Retinopathy of Prematurity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Laser

Retinal laser photocoagulation

Intervention Type: PROCEDURE

Anti VEGF

Anti-VEGF intravitreous injection

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 31 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pauline LEROUX, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

LEROUX Pauline

Corbeil-Essonnes, France, France

Countries

France

Other Identifiers

2021/0053

Identifier Type: -

Identifier Source: org_study_id