Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity
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
- 1
- 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
- 是
入选标准
- •"Patients" :
- •all premature babies (<37 weeks of amenorrhea)
- •managed in the first 24 hours of life at the Reims university hospital
- •parents accepted to participate in the research - social security card
- •Inclusion Criteria "Controls" :
- •children born full term, just after each "patient" child included
- •managed in the first 24 hours of life at the Reims university hospital
- •parents accepted to participate in the research.
排除标准
- •"Patients" and "Controls"
- •Not managed in the first 24 hours of life at the Reims University Hospital,
- •Person, who has parental authority, protected by law,
- •Newborns with a life and death emergency in the first 24 h of life,
- •Person, who has parental authority, under age 18
研究组 & 干预措施
Patients = premature newborns
"Patients" will consist of all premature babies (<37 weeks of amenorrhea), managed in the first 24 hours of life at the Reims university hospital for whom parents accepted to participate in the research Additional taking blood
干预措施: Additional taking blood (Biological)
"Controls" = children born full term
For "controls" the participation to research would be proposed to parents of children born full term, just after each "patient" child included.
Additional taking blood
干预措施: Additional taking blood (Biological)
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