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临床试验/NCT05152862
NCT05152862已完成不适用

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

Centre Hospitalier Sud Francilien1 个研究点 分布在 1 个国家目标入组 886 人开始时间: 2022年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
886
试验地点
1
主要终点
Number of infants with type 1 or 2 ROP found at routine screening.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
0 Years 至 31 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • infants died before 28 days PNA
  • infants with hydrocephaly.
  • infants with significant congenital malformations or genetic abnormalities.

结局指标

主要结局

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

时间窗: Day 0

Number

次要结局

  • Time from first retinal examination to diagnostic of severe ROP(Day 0)
  • Time from first retinal examination to treatment of ROP(Day 0)
  • Postnatal age / SAC at first by gestational age(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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