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临床试验/NCT01949896
NCT01949896终止不适用

Impact of Feeding on Pro-Inflammatory Cytokine Response in Neonates Receiving a RBC Transfusion

Christiana Care Health Services2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Ellefson

MD / Neonatal Fellow

Christiana Care Health Services

研究点 (2)

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