Skip to main content
OpenTrials
Completed

NCT Number: NCT05152862

Improve Screening Criteria for Retinopathy of Prematurity in Two French Center

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LASER

Procedure

Retinal laser photocoagulation

Anti VEGF

Procedure

Anti-VEGF intravitreous injection

Primary outcomes

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

    Time frame: Day 0

    Number

Secondary outcomes

  1. Time from first retinal examination to treatment of ROP

    Time frame: Day 0

    days

  2. Postnatal age / SAC at first by gestational age

    Time frame: Day 0

    days

  3. Time from first retinal examination to diagnostic of severe ROP

    Time frame: Day 0

    days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

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

Acronym: DEREP3

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2021
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.