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临床试验/NCT02820662
NCT02820662已完成不适用

Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in Newborns

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Stage of retinopathy of prematurity using a Retcam according to the ICROP classification (International Classification of Retinopathy of Prematurity) revised in 2005.

研究概览

简要总结

The development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of prematurity. Among the different factors affecting the development of the retinal vasculature, the tissue level of omega-3 polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the PUFA present in the tissues (nature of the phospholipids in their membranes). This project aims to show a possible association between levels of omega-3 PUFA and the onset of retinopathy of prematurity (ROP).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
0 Months 至 4 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Premature new-born infants born at less than 29 weeks of amenorrhea after informed consent has been obtained from a parent or the legal guardian of the infant

排除标准

  • Premature new-born infants presenting a life-threatening condition. Persons without national health insurance cover

研究组 & 干预措施

RETCAM

Experimental

干预措施: RETCAM (Other)

RETCAM

Experimental

干预措施: Blood samples (Biological)

结局指标

主要结局

Stage of retinopathy of prematurity using a Retcam according to the ICROP classification (International Classification of Retinopathy of Prematurity) revised in 2005.

时间窗: At 4 weeks of life or 31 weeks of amenorrhea

次要结局

  • Concentrations of omega-3 PUFA in Red Blood Cell (RBC) membranes.(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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