Case-control Study Evaluating the Impact of p16Ink4a in Bronchopulmonary Dysplasia in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- p16 expression
研究概览
简要总结
The bronchopulmonary dysplasia (BPD) is a respiratory disease of the premature child which lead to a reduction of gas exchange surface and to a prolonged respiratory failure. This disease has morphologic and functional consequences at adulthood and is today considered to be an early determinant of respiratory diseases at adulthood.
The physiopathology of BPD is not well known. Several mechanisms could be involved especially a reparation failure favored by an increase of cellular senescence which is a permanent stop of cellular proliferation. The transcription factor 16 Ink4a, considered as a marker of aging, is one of the essential markers of senescence. Its increase during prematurity was shown at the blood cells of the cordon, but its involvement in BPD and its evolution in child are not yet studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature(< 28 GA) neonates
- •Alive neonate born at less than 28 gestational age
- •Signed inform consent
- •Term neonates:
- •Alive neonate born at least at 37 GA or more
- •Signed inform consent
- •Child from 7 to 15 years old with BPD:
- •Child from 7 to 15 years old
- •Child with a BPD diagnosed
- •Signed inform consent
- •Child from 7 to 15 years old without BPD:
- •Child from 7 to 15 years old
- •Child receiving a blood test
- •Signed inform consent
排除标准
- •Premature (< 28 GA) and term neonates:
- •Congenital malformation
- •Child from 7 to 15 years old with BPD:
- •Cystic fibrosis
- •Evolutive cancer
- •Chronic inflammatory disease
- •Known anemia
- •Refusal of participation of child or parental authority
- •Child from 7 to 15 years old without BPD:
- •Other respiratory disease: severe asthma, cystic fibrosis, deficit AAT, bronchial dilatation
- •Evolutive cancer
- •Chronic inflammatory disease
- •Known anemia
- •Refusal of participation of child or parental authority
结局指标
主要结局
p16 expression
时间窗: Day 1
p16 expression measured by qPCR in newborns cord blood cells and in circulating leukocytes of children aged from 7 to 15
次要结局
- Telomeres length(Day 1)
- Genetic expression of p21, p53, H2Ax(Day 1)