DEREP3: Improve Screening Criteria for Retinopathy of Prematurity in Two French Center
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- Number of infants with type 1 or 2 ROP found at routine screening. [Day 0]
Number
Secondary Outcome Measures
- Time from first retinal examination to treatment of ROP [Day 0]
days
- Postnatal age / SAC at first by gestational age [Day 0]
days
- Time from first retinal examination to diagnostic of severe ROP [Day 0]
days
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Infant with gestational age < 31 weeks and/or birth weight < 1250 g
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With at least one retinal examination
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holders of the parental rights informed and not objecting to the study
Exclusion Criteria:
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infants died before 28 days PNA
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infants with hydrocephaly.
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infants with significant congenital malformations or genetic abnormalities.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LEROUX Pauline | Corbeil-Essonnes | France | 91106 |
Sponsors and Collaborators
- Centre Hospitalier Sud Francilien
Investigators
- Principal Investigator: Pauline LEROUX, MD, Centre Hospitalier Sud Francilien
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/0053