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临床试验/NCT02787980
NCT02787980已完成不适用

Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity

CHU de Reims2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2015年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
87
试验地点
2
主要终点
serum tryptase levels

研究概览

简要总结

Compare serum tryptase levels of premature babies (<37 weeks of amenorrhea) to children born at full term.

Study the evolution of serum tryptase levels in premature babies(<37 weeks of amenorrhea). Study the relationship between the onset of infectious complications, mainly the type of necrotizing enterocolitis seen in premature babies (<37 weeks of amenorrhea) and the evolution profile of serum tryptase levels.

详细描述

It seems appropriate to believe that prematurity associated or not with a genetic-related sensitivity, involving several signaling pathways, makes children more vulnerable to different environmental, infectious factors that could trigger the different pathologies of premature babies. Mast cell, via its mediators, seems to play a key role.

Dosage of serum tryptase levels which is easily accessible and the work by Vitte let us imagine that the younger the child, the greater the mast cell expression, thus opening a capital pathway in the comprehension of immune system phenomena in premature babies and investigators can hope that by performing regular workups of serum tryptase levels, investigators could validate that some premature babies will express this activity in a more important manner. The relationship to eventual pathological phenomena such as necrotizing enterocolitis, but also bronchopulmonary dysplasia could then be highlighted.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

serum tryptase levels

时间窗: infants born before 37 weeks of gestation:Day 1, day 7 and then every 15 days until new borns go home(up to 4 months). infants born after 37 weeks of gestation at Day 3

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

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