Improve Screening Criteria for Retinopathy of Prematurity in Two French Center

Retinopathy of Prematurity Clinical Trial

— DEREP3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05152862
• Other study ID #: 2021/0053
• Status: Completed
• Start date: March 21, 2022
• Est. completion date: June 16, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 886
• Est. completion date: June 16, 2022
• Est. primary completion date: June 16, 2022
• Gender: All
• Age group: 0 Years to 31 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Procedure:
• Laser
Retinal laser photocoagulation
• Anti VEGF
Anti-VEGF intravitreous injection

Locations

Country	Name	City	State
France	LEROUX Pauline	Corbeil-Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of infants with type 1 or 2 ROP found at routine screening.	Number	Day 0
Secondary	Time from first retinal examination to treatment of ROP	days	Day 0
Secondary	Postnatal age / SAC at first by gestational age	days	Day 0
Secondary	Time from first retinal examination to diagnostic of severe ROP	days	Day 0