Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Necrotizing enterocolitis
研究概览
简要总结
Necrotizing enterocolitis (NEC) is a leading cause of mortality among preterm infants.The pathogenesis of NEC remains unclear with conflicting data regarding the role of red blood cell (RBC) transfusion and anemia. A meta-analysis of retrospective studies demonstrated an association between exposure to RBC transfusion and NEC(adjusted odds ratio, 2.0 [95% confidence interval, 1.6-2.5]). However, recent observational studies have found no association between RBC transfusion and NEC or have found RBC transfusion to be protective.
详细描述
Improving understanding of the role of RBC transfusion and anemia in the development of NEC is important. Several studies characterizing the associations between transfusion, anemia, and NEC were potentially limited by small sample size, study design. As such, researchers have underscored the need for prospective study in which each RBC exposure, episode of anemia, and outcome of NEC can be systematically and consistently evaluated.
This prospective study examined whether RBC transfusion and anemia were associated with the rate of NEC. The primary objective was to test whether NEC was increased in infants receiving RBC transfusion compared with non transfused infants. Further, exposure to severe neonatal anemia was examined as an independent risk factor for NEC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 1 min and 28 days
- •the level blood bilirubin reached the criteria of transfusion therapy
排除标准
- •congenital abnormalities
- •receipt of transfusion before enrollment
- •parents' decision not to participate
- •infant not expected to survive beyond 7 days of life based on the assessment by the treating neonatologist
结局指标
主要结局
Necrotizing enterocolitis
时间窗: within 28 days
Necrotizing enterocolitis was diagnosed within 28 days
次要结局
- death(within 28 days)
研究者
Chen Long,MD
director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University