Impact of Feeding on Pro-Inflammatory Cytokine Response in Neonates Receiving a RBC Transfusion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Pro-inflammatory cytokine response
研究概览
简要总结
Prior to a non-urgent blood transfusion, subjects will be randomized to either stopping feeds or continuing feeds. The intervention group will be the placement of a subject in the NPO group. Subjects in the intervention group will have their feedings stopped for a total of 24 hours around the time of the PRBC transfusion. These infants will be given intravenous nutrition during the period of time that they will not be fed. During the transfusion, both groups of subjects will have serum cytokine levels obtained at 3 time intervals- 1) 4 hours pre-transfusion, 2) 2-4 hours post-transfusion, and 3) 20-24 hours post-transfusion.
详细描述
Recently many publications have indicated a potential temporal association between packed red blood cell (PRBC) transfusion and the development of NEC in neonates. Although, to date, there is no conclusive evidence indicating a causal role of PRBC transfusion on the development of NEC. Given the growing body of data that support the association of PRBC transfusions and NEC, a common clinical dilemma arises with regard to feeding infants during a blood transfusion. Additionally, it is thought that increased immunomodulation may be exacerbated by any other pro-inflammatory process or insult; thereby leading to a rapidly increasing cascade of pro-inflammatory cytokines which may ultimately lead to gut inflammation and NEC.
Prior to a non-urgent PRBC transfusion, subjects will be randomized to either the NPO group or fed group of patients. The intervention will be the placement of a subject in the NPO group. Subjects will be made NPO for a total of 24 hours around the time of the PRBC transfusion. During the transfusion, both groups of subjects will have serum cytokine levels obtained at 3 time intervals- 1) 4 hours pre-transfusion, 2) 2-4 hours post-transfusion, and 3) 20-24 hours post-transfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born < 31 weeks gestational age
- •Between 3 and 7 days old at time of consent
排除标准
- •Infants with multiple congenital anomalies
- •Infant with suspected/confirmed genetic anomalies
- •Infant with suspected/confirmed congenital immune deficiencies
结局指标
主要结局
Pro-inflammatory cytokine response
时间窗: 24 hours
Evaluate the pro-inflammatory cytokine response in both fed and NPO infants during a transfusion
次要结局
未报告次要终点
研究者
Andrew Ellefson
MD / Neonatal Fellow
Christiana Care Health Services
