Improve Screening Criteria for Retinopathy of Prematurity in Two French Center (DEREP3)

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

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.

Study Overview

• Status: Completed
• Conditions: Retinopathy of Prematurity
• Intervention / Treatment: Procedure: Laser; Procedure: Anti VEGF

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.

• Study Type: Observational
• Enrollment (Actual): 886

Contacts and Locations

Study Locations

• France
  • Corbeil-Essonnes, France, 91106
    • LEROUX Pauline

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 7 months (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cohort will be selected among all premature born between January 2016 and November 2020 and hospitalized in Centre Hospitalier Sud Francilien (Corbeil Essonnes 91) and Hopital Robert Debré (Paris 75).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infants with type 1 or 2 ROP found at routine screening.	Number	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from first retinal examination to treatment of ROP	days	Day 0
Postnatal age / SAC at first by gestational age	days	Day 0
Time from first retinal examination to diagnostic of severe ROP	days	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien
• Investigators: Principal Investigator: Pauline LEROUX, MD, Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 21, 2022
• Primary Completion (ACTUAL): June 16, 2022
• Study Completion (ACTUAL): June 16, 2022

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (ACTUAL): December 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: screening; premature; birth weight; retina; gestational age
• Additional Relevant MeSH Terms: Eye Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Retinal Diseases; Premature Birth; Retinopathy of Prematurity
• Other Study ID Numbers: 2021/0053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No