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临床试验/NCT01865435
NCT01865435已完成不适用

IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
cord blood samples

研究概览

简要总结

Actually, there is an increasing number of arguments for a premature origin of chronic adult's diseases, as the chronic obstructive pulmonary disease (COPD). Several factors interacting with the foetal or postnatal lung growth are associated with early and long-lasting respiratory functional changes susceptible to contribute very significantly to the arisen of a COPD in the adulthood. It is possible that these situations reflect phenomena of premature cellular senescence, recently involved in the physiopathology of the COPD. An in utero exposition to cigarette smoking is one of these situations, because it is known to induce, not only functional respiratory changes, but also multiple diseases in the child which could testify of cellular ageing phenomena.

Our project aims to demonstrate that in utero smoking is associated with markers of premature cellular senescence in newborn children

The study will be driven in human newborn child's, with comparison of the length of the telomeres in circulating lymphocytes (umbilical blood is collected), according to the exposure in in utero smoking and also according to the degree of hypotrophy. This study will be a pilot study completed by an animal experimental study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
— 至 27 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Born weight upper or equal to the 10th percentile and absence of smoking declared by the mother
  • Born weight lower than the 10th percentile and absence of smoking declared by the mother
  • Born weight upper or equal to the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day
  • Born weight lower than the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day

排除标准

  • Gestationnel age 37 LIMITED COMPANIES
  • Low(Weak) declaratory(declarative) maternal smoking (1 in 4 cigarettes a day)
  • Pathologies associated by the newborn child (deformations, foetal suffering, infection maternofœtale, respiratory distress syndrome)

结局指标

主要结局

cord blood samples

时间窗: 12months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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